TARS Tarsus Pharmaceuticals Inc.
Upcoming Catalysts
| Drug | Stage | Catalyst Date |
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TP-03 - Saturn-1
Demodex Blepharitis
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Phase 2/3
Phase 2/3
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Drug Pipeline
| Drug | Stage | Notes |
|---|---|---|
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TP-03 (Saturn-2)
Demodex Blepharitis
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Phase 3
Phase 3
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Phase 3 trial initiation announced May 6, 2021.
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TP-05
Healthy volunteers
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Phase 1
Phase 1
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Phase 1 trial to be initiated July 2021.
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Latest News
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Initiated Saturn-2, second pivotal Phase 3 trial evaluating the safety and efficacy of TP-03 for the treatment of Demodex blepharitis; topline data from Saturn-1 expected this July
Announced FDA acceptance of IND for TP-05, a novel candidate in development that aims to be first approved non-vaccine therapeutic for Lyme disease prevention
Presented results of pioneering Atlas study at ARVO 2021 Annual Meeting demonstrating the functional and psychosocial impact of Demodex blepharitis
Cash and cash equivalents of $156.2 million as of March 31, 2021; excludes Greater China out-license initial proceeds received in April and May 2021 of $25 million
IRVINE, Calif., May 11, 2021 (GLOBE NEWSWIRE) -- Tarsus Pharmaceuticals, Inc. (NASDAQ:TARS), a late clinical-stage biopharmaceutical company whose mission is to focus on unmet needs and apply proven science and new technology to revolutionize treatment for patients, starting with eye care, today announced financial results and certain business and clinical updates for the quarter ended March 31, 2021.
"During the quarter, the company continued to execute on our pipeline goals for our most advanced program, TP-03 in Demodex blepharitis, as well as for our second asset, TP-05 for Lyme disease prevention," said Bobak Azamian, M.D., Ph.D., President and Chief Executive Officer of Tarsus. "Initiating the second pivotal Phase 3 trial for TP-03, Saturn-2, while planning for the topline data read-out from Saturn-1, now expected this July, moves us closer towards potential commercialization of a treatment for Demodex blepharitis. We have increased confidence in the market opportunity and need for a therapeutic option for the 25 million Americans that may be affected by this common ocular disease with no currently FDA-approved therapies."
Recent Business Highlights and Corporate Update:
- Announced commencement of Saturn-2 enrollment, Tarsus' second pivotal Phase 3 trial evaluating the company's novel investigational treatment, TP-03, in patients with Demodex blepharitis. Up to 25 million Americans may be affected by Demodex blepharitis, which is caused by an infestation of Demodex mites. TP-03 is a topical ophthalmic formulation of lotilaner, a well-characterized anti-parasitic agent designed to target and eradicate Demodex mites. Tarsus also recently completed enrollment for the Phase 2b/3 Saturn-1 pivotal trial, with 421 patients. Topline results of the trial are expected to be announced this July.
- Announced that the U.S. Food and Drug Administration (FDA) has accepted the Company's Investigational New Drug (IND) application for TP-05, an oral, non-vaccine therapeutic for the prevention of Lyme disease. With this IND acceptance, Tarsus plans to initiate a Phase 1 single ascending dose and multiple ascending dose (SAD/MAD) study to evaluate the safety, tolerability, and pharmacokinetics (PK) of TP-05 in healthy volunteers. Study initiation is anticipated in July.
- Presented data from its Atlas study at the virtual Association for Research in Vision and Ophthalmology (ARVO) 2021 Annual Meeting. The Atlas study is the first multi-center observational study to evaluate the functional and psychosocial impact of Demodex blepharitis, along with clinical manifestations, in adult patients. Overall, the study showed that Demodex blepharitis is associated with a significant symptomatic and psychosocial burden, negatively affecting daily life in the majority (80%) of patients with the disease.
- Also at ARVO, Tarsus presented the complete findings of the Europa study, a prospective, randomized, vehicle-controlled Phase 2b trial that evaluated the safety and efficacy of twice-daily TP-03, topical lotilaner ophthalmic solution 0.25%, in adult patients with Demodex blepharitis. In the trial, TP-03 demonstrated statistically significant results for the primary endpoint, collarette cure over vehicle, which was achieved in 80% of patients versus 16%, respectively, at 42 days (p<0.001) and the secondary endpoint of mite eradication, which was achieved in 73% of patients treated with TP-03 versus 21% of the vehicle group (p=0.003). There were no serious adverse events and no discontinuations due to adverse events.
- In March 2021, Tarsus announced its strategic partnership with LianBio Ophthalmology Limited (LianBio) to develop and commercialize TP-03 in Greater China (PRC, Hong Kong, Taiwan, and Macau) for the treatment of Demodex blepharitis and Meibomian Gland Disease (MGD), eye conditions with significant unmet treatment needs. In this arrangement, LianBio obtained exclusive TP-03 development and commercialization rights to Greater China for the treatment of Demodex blepharitis and MGD. As initial time-based consideration, LianBio paid Tarsus $15 million in April 2021 and $10 million in May 2021. LianBio remains contractually obligated to: (i) pay Tarsus up to $175 million in clinical, regulatory, and sales milestones upon achievement, (ii) pay Tarsus tiered low double-digit royalties on its sales of TP-03 in Greater China, and (iii) grant Tarsus equity warrants in LianBio, subject to vesting provisions. Assuming Tarsus achieves remaining U.S. clinical milestones for TP-03, as expected by March 2022, cumulative proceeds from LianBio will total $70 million within the first 12 months following agreement execution.
First Quarter 2021 Financial Results
- First quarter net income for 2021 was $10.4 million, compared to a net loss of $(2.0) million for the same period in 2020.
- First quarter 2021 license fee and collaboration revenue, as part of strategic partnership with LianBio, was $33.4 million; and $1.3 million in associated expense in proportion to this revenue.
- First quarter research and development expenses for 2021 were $16.3 million (inclusive of non-cash stock-based charges of $5.8 million), compared to $1.5 million for the same period in 2020.
- First quarter general and administrative expenses for 2021 increased to $5.2 million (inclusive of non-cash stock-based charges of $1.0 million), compared to $0.6 million for the same period in 2020.
- As of March 31, 2021, cash and cash equivalents were $156.2 million.
About Tarsus Pharmaceuticals, Inc.
Tarsus Pharmaceuticals, Inc. is a late clinical-stage biopharmaceutical company that applies proven science and new technology to revolutionize treatment for patients, starting with eye care. It is advancing its pipeline to address several diseases with high unmet need across a range of therapeutic categories, including eye care, dermatology, and infectious disease prevention. Its lead product candidate, TP-03, is a novel therapeutic being studied in two pivotal trials for the treatment of Demodex blepharitis. TP-03 is also being developed for the treatment of Meibomian Gland Disease.Forward-Looking Statements
Statements in this press release about future expectations, plans and prospects, as well as any other statements regarding matters that are not historical facts, may constitute "forward-looking statements." These statements include statements regarding the receipt by Tarsus of future payments and achievement and timing of milestones under the terms of the collaboration with LianBio, the ability of LianBio to commercialize TP-03 in the Greater China territory, the market size for TP-03 and TP-05, future events and Tarsus' plans for and the anticipated benefits of its product candidates including TP-03 and TP-05, the timing, objectives and results of the clinical studies, anticipated regulatory and development milestones and the quotations of Tarsus' management. The words, without limitation, "believe," "contemplate," "continue," "could," "estimate," "expect," "intend," "may," "might," "plan," "potential," "predict," "project," "should," "target," "will," or "would," or the negative of these terms or other similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these or similar identifying words. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors. Important factors that could cause actual results to differ materially from those in the forward-looking statements include: Tarsus has incurred significant losses and negative cash flows from operations since inception and anticipates that it will continue to incur significant expenses and losses for the foreseeable future; Tarsus may need to obtain additional funding to complete the development and any commercialization of its product candidates, if approved; Tarsus is heavily dependent on the success of its lead product candidate, TP-03 for the treatment of Demodex blepharitis; the COVID-19 pandemic may affect Tarsus' ability to initiate and complete preclinical studies and clinical trials, disrupt regulatory activities, disrupt manufacturing and supply chain or have other adverse effects on Tarsus' business and operations; even if TP-03, TP-05, or any other product candidate that Tarsus develops receives marketing approval, Tarsus may not be successful in educating eye care physicians and the market about the need for treatments specifically for Demodex blepharitis, Lyme disease, and/or other diseases or conditions targeted by Tarsus' products; the development and commercialization of Tarsus products is dependent on intellectual property it licenses from Elanco Tiergesundheit AG; Tarsus will need to develop and expand the company and Tarsus may encounter difficulties in managing its growth, which could disrupt its operations; the sizes of the market opportunity for Tarsus' product candidates, particularly TP-03 for the treatment of Demodex blepharitis and MGD, as well as TP-05 for the treatment of Lyme disease, have not been established with precision and may be smaller than estimated; the results of Tarsus' earlier studies and trials may not be predictive of future results; any termination or suspension of, or delays in the commencement or completion of, Tarsus' planned clinical trials could result in increased costs, delay or limit its ability to generate revenue and adversely affect its commercial prospects; and if Tarsus is unable to obtain and maintain sufficient intellectual property protection for its product candidates, or if the scope of the intellectual property protection is not sufficiently broad, Tarsus' competitors could develop and commercialize products similar or identical to Tarsus' products. Further, there are other risks and uncertainties that could cause actual results to differ from those set forth in the forward-looking statement and they are detailed from time to time in the reports Tarsus files with the Securities and Exchange Commission, including Tarsus' Form 10-K for the year ended December 31, 2020 filed with the SEC on March 31, 2021, which Tarsus incorporates by reference into this press release, copies of which are posted on its website and are available from Tarsus without charge. However, new risk factors and uncertainties may emerge from time to time, and it is not possible to predict all risk factors and uncertainties. Accordingly, readers are cautioned not to place undue reliance on these forward-looking statements. Any forward-looking statements contained in this press release are based on the current expectations of Tarsus' management team and speak only as of the date hereof, and Tarsus specifically disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events or otherwise.Media Contact: SuJin Oh Shop PR (917) 841-5213 [email protected] Investor Contact: Patti Bank Westwicke Partners, an ICR company (415) 513-1284 [email protected] TARSUS PHARMACEUTICALS, INC.
STATEMENTS OF OPERATIONS AND COMPREHENSIVE INCOME (LOSS)
(In thousands, except share and per share amounts)Three Months Ended
March 31,2021 2020 Revenues: License fees $ 33,311 $ — Collaboration revenue 121 — Total revenues 33,432 — Operating expenses: Cost of license fees and collaboration revenue 1,297 — Research and development 16,261 1,512 General and administrative 5,160 606 Total operating expenses 22,718 2,118 Income (loss) from operations before other (expense) income and income taxes 10,714 (2,118 ) Other (expense) income: Interest income (expense), net 9 161 Other (expense) income, net (34 ) — Total other (expense) income (25 ) 161 Provision for income taxes (313 ) — Net income (loss) and comprehensive income (loss) $ 10,376 $ (1,957 ) Net income (loss) per share Basic $ 0.51 $ (0.74 ) Diluted $ 0.47 $ (0.74 ) Weighted-average shares outstanding Basic 20,336,022 2,650,363 Diluted 21,824,574 2,650,363 TARSUS PHARMACEUTICALS, INC.
BALANCE SHEETS
(In thousands, except share and par value amounts)March 31, 2021 December 31, 2020 (unaudited) ASSETS Current assets: Cash and cash equivalents $ 156,179 $ 168,129 Restricted cash 20 20 Accounts receivable 25,000 — Contract asset 7,199 — Other receivables 247 20 Prepaid expenses and other current assets 2,806 2,486 Total current assets 191,451 170,655 Property and equipment, net of accumulated depreciation 589 548 Operating lease right-of-use asset 584 688 Other assets 1,330 81 Total assets $ 193,954 $ 171,972 LIABILITIES, PREFERRED STOCK AND STOCKHOLDERS' EQUITY Current liabilities: Accounts payable and other accrued liabilities $ 9,433 $ 4,347 Accrued payroll and benefits 685 1,040 Total current liabilities 10,118 5,387 Other long-term liabilities 604 605 Total liabilities 10,722 5,992 Commitments and contingencies (Note 9) Stockholders' equity: Preferred stock, $0.0001 par value; 10,000,000 authorized at March 31, 2021 and
December 31, 2020; no shares issued and outstanding at March 31, 2021 and
December 31, 2020— — Common stock, $0.0001 par value; 200,000,000 shares authorized; 20,703,849 shares
issued and 20,524,474 outstanding, which excludes 179,375 shares subject to
repurchase at March 31, 2021 (unaudited); 20,502,576 shares issued and 20,323,301
outstanding, which excludes 179,375 shares subject to repurchase at December 31, 20204 4 Additional paid-in capital 205,697 198,821 Accumulated deficit (22,469 ) (32,845 ) Total stockholders' equity 183,232 165,980 Total liabilities, preferred stock and stockholders' equity $ 193,954 $ 171,972 
- Announced commencement of Saturn-2 enrollment, Tarsus' second pivotal Phase 3 trial evaluating the company's novel investigational treatment, TP-03, in patients with Demodex blepharitis. Up to 25 million Americans may be affected by Demodex blepharitis, which is caused by an infestation of Demodex mites. TP-03 is a topical ophthalmic formulation of lotilaner, a well-characterized anti-parasitic agent designed to target and eradicate Demodex mites. Tarsus also recently completed enrollment for the Phase 2b/3 Saturn-1 pivotal trial, with 421 patients. Topline results of the trial are expected to be announced this July.
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Demodex blepharitis may affect up to 25 million Americans and result in significant clinical, functional and psychosocial burden for patients
Saturn-2 trial design similar to Saturn-1, first pivotal trial for TP-03
Topline data from Saturn-1 expected this July
IRVINE, Calif., May 06, 2021 (GLOBE NEWSWIRE) -- Tarsus Pharmaceuticals, Inc. (NASDAQ:TARS), a late clinical-stage biopharmaceutical company whose mission is to focus on unmet needs and apply proven science and new technology to revolutionize treatment for patients, starting with eye care, today announced that it has commenced enrollment in Saturn-2, its second pivotal trial evaluating the company's novel investigational treatment, TP-03, in patients with Demodex blepharitis. Up to 25 million Americans may be affected by Demodex blepharitis, which is caused by an infestation of Demodex mites. TP-03 is a topical ophthalmic formulation of lotilaner, a well-characterized anti-parasitic agent designed to target and eradicate Demodex mites. Tarsus also recently completed full enrollment for the Saturn-1 pivotal trial, with 421 patients; topline results of the trial are expected to be announced this July.
Demodex blepharitis is a common, yet often overlooked or misdiagnosed, ocular disease that is characterized by inflammation of the eyelid margin, redness and ocular irritation. The disease is associated with significant clinical, functional and psychosocial burdens, with the recently presented Atlas study revealing that the majority of patients (80%) say the disease negatively affects their daily life. Currently, there is no FDA-approved therapy for the disease.
"We are pleased to complete first patient visits in Saturn-2, our second pivotal trial of TP-03 in Demodex blepharitis," said Bobak Azamian, M.D., Ph.D., President and Chief Executive Officer of Tarsus. "Fully enrolling the Saturn-1 trial in a timely manner underscores patients' significant need for a safe and effective therapy, and we look forward to sharing the topline results this July. Demodex blepharitis can have a major impact on patients as evidenced by the Atlas study of participants pre-screened for Saturn-1. We are committed to progressing TP-03 with the goal of potentially providing the first FDA-approved drug treatment for this disease."
The Saturn-2 trial has a similar design to Saturn-1, and is a randomized, controlled, multicenter, double-masked trial studying the safety and efficacy of TP-03, lotilaner ophthalmic solution 0.25%, in adults with Demodex blepharitis. The trial's primary endpoint is the proportion of patients achieving collarette cure, defined as 0 to 2 eyelashes with collarettes. Secondary endpoints include the eradication of Demodex mites and the proportion of patients achieving a cure based on a composite of collarette cure and erythema cure (eyelid redness). We expect Saturn-2 to enroll approximately 418 participants who will administer TP-03 or vehicle twice daily for 42 days.
Tarsus has completed four Phase 2 clinical trials of TP-03 in Demodex blepharitis, all of which met their respective endpoints with no significant adverse events nor any events leading to treatment discontinuation. The positive results from these trials guided the design of the Saturn-1 and Saturn-2 pivotal trials. If the Saturn-1 and Saturn-2 trials are positive, we expect they will support the submission of a New Drug Application (NDA) to the United States Food and Drug Administration (FDA) for TP-03 for the treatment of Demodex blepharitis.
About TP-03
TP-03 (lotilaner ophthalmic solution, 0.25%) is a novel, investigational therapeutic designed to target and eradicate Demodex mites. It is a potent, non-competitive antagonist of insect and arachnid GABA-Cl channels and a highly lipophilic molecule, which may promote its uptake in the oily sebum of the hair follicle where the mites reside. Tarsus has completed four Phase 2 clinical trials of TP-03 in Demodex blepharitis, all of which met their respective endpoints with no significant adverse events nor any events leading to treatment discontinuation. TP-03 is currently being evaluated in the Saturn-1 and Saturn-2 pivotal trials. If approved, TP-03 may offer treatment for millions of patients around the world with Demodex blepharitis.About Demodex Blepharitis
Blepharitis is a common ocular condition that is characterized by inflammation of the eyelid margin, redness and ocular irritation. Demodex blepharitis is caused by infestation of Demodex mites, the most common ectoparasite found on humans. Demodex mites cause approximately 45% of blepharitis, or about 9 million cases in the US and the number may be as high as approximately 25 million based on Tarsus' internal research indicating about 58% of patients presenting to eye care clinics have collarettes, a pathognomonic sign of Demodex infestation, and a published study estimating that at least 45 million people annually visit an eye care clinic. Currently, there are no FDA-approved treatments for Demodex blepharitis.About Tarsus Pharmaceuticals, Inc.
Tarsus Pharmaceuticals, Inc. is a late clinical-stage biopharmaceutical company that applies proven science and new technology to revolutionize treatment for patients, starting with eye care. It is advancing its pipeline to address several diseases with high unmet need across a range of therapeutic categories, including eye care, dermatology, and infectious disease prevention. Its lead product candidate, TP-03, is a novel therapeutic being studied in two pivotal trials for the treatment of Demodex blepharitis. TP-03 is also being developed for the treatment of Meibomian Gland Disease.Forward-Looking Statements
Statements in this press release about future expectations, plans and prospects, as well as any other statements regarding matters that are not historical facts, may constitute "forward-looking statements." These statements include statements regarding the market size for TP-03, enrollment expectations in the Saturn-2 trial, timing of topline data for Saturn-1, future events and Tarsus' plans for and the anticipated benefits of its product candidates, including TP-03, the timing, objectives and results of the clinical trials and anticipated regulatory and development milestones and the quotations of Tarsus' management. The words, without limitation, "believe," "contemplate," "continue," "could," "estimate," "expect," "intend," "may," "might," "plan," "potential," "predict," "project," "should," "target," "will" or "would" or the negative of these terms or other similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these or similar identifying words. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors. Important factors that could cause actual results to differ materially from those in the forward-looking statements include: Tarsus has incurred significant losses and negative cash flows from operations since inception and anticipates that it will continue to incur significant expenses and losses for the foreseeable future; Tarsus may need to obtain additional funding to complete the development and any commercialization of its product candidates, if approved; Tarsus is heavily dependent on the success of its lead product candidate, TP-03 for the treatment of Demodex blepharitis; the COVID-19 pandemic may affect Tarsus' ability to initiate and complete preclinical studies and clinical trials, disrupt regulatory activities, disrupt manufacturing and supply chain or have other adverse effects on Tarsus' business and operations; even if TP-03 or any other product candidate that Tarsus develops receives marketing approval, Tarsus may not be successful in educating eye care physicians and the market about the need for treatments specifically for Demodex blepharitis and or other diseases or conditions targeted by Tarsus' products; the development and commercialization of Tarsus products is dependent on intellectual property it licenses from Elanco Tiergesundheit AG; Tarsus will need to develop and expand the company and Tarsus may encounter difficulties in managing its growth, which could disrupt its operations; the sizes of the market opportunity for Tarsus' product candidates, particularly TP-03 for the treatment of Demodex blepharitis and MGD, have not been established with precision and may be smaller than estimated; the results of Tarsus' earlier studies and trials may not be predictive of future results; any termination or suspension of, or delays in the commencement or completion of, Tarsus' planned clinical trials could result in increased costs, delay or limit its ability to generate revenue and adversely affect its commercial prospects; and if Tarsus is unable to obtain and maintain sufficient intellectual property protection for its product candidates, or if the scope of the intellectual property protection is not sufficiently broad, Tarsus' competitors could develop and commercialize products similar or identical to Tarsus' products. Further, there are other risks and uncertainties that could cause actual results to differ from those set forth in the forward-looking statement and they are detailed from time to time in the reports Tarsus files with the Securities and Exchange Commission, including Tarsus' Form 10-K for the year ended December 31, 2020 filed with the SEC on March 31, 2021, which Tarsus incorporates by reference into this press release, copies of which are posted on its website and are available from Tarsus without charge. However, new risk factors and uncertainties may emerge from time to time, and it is not possible to predict all risk factors and uncertainties. Accordingly, readers are cautioned not to place undue reliance on these forward-looking statements. Any forward-looking statements contained in this press release are based on the current expectations of Tarsus' management team and speak only as of the date hereof, and Tarsus specifically disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events or otherwise.Contacts:
Media Contact:
SuJin Oh
Shop PR
(917) 841-5213
[email protected]Investor Contact:
Patti Bank
Westwicke Partners, an ICR company
(415) 513-1284
[email protected] -
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Novel candidate in development aims to be first approved non-vaccine therapeutic for Lyme disease prevention
Allows initiation of Phase 1 study to evaluate safety, pharmacokinetics, and dosing
More than 30 million Americans at risk for Lyme disease exposure, which can result in severe neurological and other debilitating symptoms
IRVINE, Calif., May 04, 2021 (GLOBE NEWSWIRE) -- Tarsus Pharmaceuticals, Inc. (NASDAQ:TARS), a late clinical-stage biopharmaceutical company whose mission is to focus on unmet needs and apply proven science and new technology to revolutionize treatment for patients, starting with eye care, today announced that the U.S. Food and Drug Administration (FDA) has accepted the Company's Investigational New Drug (IND) application for TP-05, an oral, non-vaccine therapeutic for the prevention of Lyme disease. With this IND acceptance, Tarsus will initiate a Phase 1 single ascending dose and multiple ascending dose (SAD/MAD) study to evaluate the safety, tolerability, and pharmacokinetics (PK) of TP-05 in healthy volunteers. Study initiation is anticipated in July.
"We are pleased that the FDA has accepted the IND for TP-05, which is an important milestone in our pipeline development. Currently, there are no approved pharmacological prophylactic options for tick kill and preventing transmission of Lyme disease, which has the potential to cause severe, often debilitating symptoms with permanent and irreversible damage," said Bobak Azamian, M.D., Ph.D., President and Chief Executive Officer of Tarsus. "There is a significant unmet need for a therapeutic to quickly and reliably prevent this disease that can lead to poor outcomes for so many people. We look forward to initiating our clinical development program for TP-05 and advancing the path for this much-needed therapeutic for Lyme disease prevention."
Lyme disease is transmitted to humans after the bite of a blacklegged tick infected with the Borrelia bacteria. It is the most common vector-borne disease in the United States and can result in inflammation, nerve, joint and muscle pain and swelling, numbness, shortness of breath and – in severe cases – neurological complications such as facial palsy, vision issues, and meningitis symptoms, including severe headaches and neck stiffness. Lyme disease impacts more than 300,000 people in the U.S. each year and over 30 million are at high or moderate risk for contracting the disease.
TP-05 is an oral systemic formulation of lotilaner, a well-characterized anti-parasitic agent that paralyzes and kills ticks by blocking the parasite-specific GABA-CI channels. TP-05 is believed to be the only non-vaccine based therapeutic in development and is designed to rapidly provide systemic blood levels of lotilaner, and kill infected ticks attached to the human body before they can transmit the Borrelia bacteria that causes Lyme disease. In addition to the prevention of Lyme disease, Tarsus is also exploring TP-05 for the community prevention of malaria.
Tarsus is currently conducting a pivotal trial evaluating the efficacy and safety of TP-03, a topical ophthalmic formulation of lotilaner, for the treatment of Demodex blepharitis, a common ocular condition caused by an infestation of Demodex mites.
About TP-05
TP-05 is an oral systemic formulation of lotilaner, a well-characterized anti-parasitic agent that paralyzes and kills parasites by inhibiting parasite-specific GABA-Cl channels. Tarsus is studying TP-05 for the prevention of Lyme disease. In July of 2021, Tarsus will initiate a Phase 1 single ascending dose and multiple ascending dose (SAD/MAD) study to evaluate the safety, tolerability and pharmacokinetics (PK) of TP-05 in healthy volunteers. In addition to Lyme disease, Tarsus is also exploring TP-05 for the community prevention of malaria.About Lyme Disease
Lyme disease is the most common vector-borne disease in the United States, transmitted to humans after the bite of a blacklegged tick infected by the bacterium Borrelia burgdorferi. Over 30 million Americans are at high or moderate risk of contracting Lyme disease and there are approximately 300,000 – 400,000 cases in the U.S. each year. People who spend extended amounts of time outdoors in wooded, grassy areas are at higher risk of getting the infection. Data from the Centers for Disease Control (CDC) shows that the risk of Lyme disease is spreading to new geographical areas, resulting in a significant need for prophylactic solutions. Currently, there are no FDA-approved pharmacological prophylactic options for Lyme disease.About Tarsus Pharmaceuticals, Inc.
Tarsus Pharmaceuticals, Inc. is a late clinical-stage biopharmaceutical company that applies proven science and new technology to revolutionize treatment for patients, starting with eye care. It is advancing its pipeline to address several diseases with high unmet need across a range of therapeutic categories, including eye care, dermatology, and infectious disease prevention. Its lead product candidate, TP-03, is a novel therapeutic in a pivotal Phase 2b/3 trial for the treatment of Demodex blepharitis. TP-03 is also being developed for the treatment of Meibomian Gland Disease.Forward-Looking Statements
Statements in this press release about future expectations, plans and prospects, as well as any other statements regarding matters that are not historical facts, may constitute "forward-looking statements." These statements include statements regarding the market size for TP-03, TP-05, future events and Tarsus' plans for and the anticipated benefits of its product candidates including TP-03, TP-05, the timing, objectives and results of the clinical studies and anticipated regulatory and development milestones and the quotations of Tarsus' management. The words, without limitation, "believe," "contemplate," "continue," "could," "estimate," "expect," "intend," "may," "might," "plan," "potential," "predict," "project," "should," "target," "will" or "would" or the negative of these terms or other similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these or similar identifying words. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors. Important factors that could cause actual results to differ materially from those in the forward-looking statements include: Tarsus has incurred significant losses and negative cash flows from operations since inception and anticipates that it will continue to incur significant expenses and losses for the foreseeable future; Tarsus may need to obtain additional funding to complete the development and any commercialization of its product candidates, if approved; Tarsus is heavily dependent on the success of its lead product candidate, TP-03 for the treatment of Demodex blepharitis; the COVID-19 pandemic may affect Tarsus' ability to initiate and complete preclinical studies and clinical trials, disrupt regulatory activities, disrupt manufacturing and supply chain or have other adverse effects on Tarsus' business and operations; even if TP-03, TP-05 or any other product candidate that Tarsus develops receives marketing approval, Tarsus may not be successful in educating physicians and the market about the need for treatments specifically for Demodex blepharitis, Lyme disease and or other diseases or conditions targeted by Tarsus' products; the development and commercialization of Tarsus products is dependent on intellectual property it licenses from Elanco Tiergesundheit AG; Tarsus will need to develop and expand the company and Tarsus may encounter difficulties in managing its growth, which could disrupt its operations; the sizes of the market opportunity for Tarsus' product candidates, particularly TP-03 for the treatment of Demodex blepharitis and MGD, as well as TP-05 for the treatment of Lyme disease, have not been established with precision and may be smaller than estimated; the results of Tarsus' earlier studies and trials may not be predictive of future results; any termination or suspension of, or delays in the commencement or completion of, Tarsus' planned clinical trials could result in increased costs, delay or limit its ability to generate revenue and adversely affect its commercial prospects; and if Tarsus is unable to obtain and maintain sufficient intellectual property protection for its product candidates, or if the scope of the intellectual property protection is not sufficiently broad, Tarsus' competitors could develop and commercialize products similar or identical Tarsus' product. Further, there are other risks and uncertainties that could cause actual results to differ from those set forth in the forward-looking statement and they are detailed from time to time in the reports Tarsus files with the Securities and Exchange Commission, including Tarsus' Form 10-K for the year ended December 31, 2020 filed with the SEC on March 31, 2021, which Tarsus incorporates by reference into this press release, copies of which are posted on its website and are available from Tarsus without charge. However, new risk factors and uncertainties may emerge from time to time, and it is not possible to predict all risk factors and uncertainties. Accordingly, readers are cautioned not to place undue reliance on these forward-looking statements. Any forward-looking statements contained in this press release are based on the current expectations of Tarsus' management team and speak only as of the date hereof, and Tarsus specifically disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events or otherwise.Contacts:
Media Contact:
SuJin Oh
Shop PR
(917) 841-5213
[email protected]Investor Contact:
Patti Bank
Westwicke Partners, an ICR company
(415) 513-1284
[email protected] -
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Demodex blepharitis is a common ocular condition that may affect up to 25 million Americans
Atlas study shows that Demodex blepharitis negatively impacts daily life for 80 percent of patients
Tarsus also presents complete efficacy and safety data from Phase 2b Europa trial, positive trial results used as the basis for the Saturn-1 & 2 pivotal trials
IRVINE, Calif., May 03, 2021 (GLOBE NEWSWIRE) -- Tarsus Pharmaceuticals, Inc. (NASDAQ:TARS), a late clinical-stage biopharmaceutical company whose mission is to focus on unmet needs and apply proven science and new technology to revolutionize treatment for patients, starting with eye care, today announced data from its Demodex blepharitis clinical program presented at the virtual Association for Research in Vision and Ophthalmology (ARVO) 2021 Annual Meeting. Demodex blepharitis is a common ocular disease that may affect as many as 25 million Americans and has both clinical and psychosocial impacts. Characterized by inflammation of the eyelid margin, redness and ocular irritation, Demodex blepharitis is caused by an infestation of Demodex mites. Currently, there is no FDA-approved therapy for the disease. Tarsus' lead product candidate, TP-03, is a topical ophthalmic formulation of lotilaner, a well-characterized anti-parasitic agent, designed to target and eradicate Demodex mites, and is currently being evaluated in the pivotal Phase 2b/3 Saturn-1 trial.
Although highly prevalent, Demodex blepharitis is often overlooked or misdiagnosed and – as a result – patients may struggle with the condition for years. Until now, the psychosocial effects of Demodex blepharitis have been poorly characterized. The Atlas study is the first multi-center observational study to evaluate the functional and psychosocial impact of the disease, along with clinical manifestations, in adult patients. Overall, the study showed that Demodex blepharitis is associated with a significant symptomatic and psychosocial burden, negatively affecting daily life in the majority (80%) of patients with the disease.
"The results from the Atlas study are significant because they demonstrate that there are severe functional and psychosocial impacts related to Demodex blepharitis with regard to routine, everyday activities and overall quality of life," said Elizabeth Yeu, M.D., Chief Medical Advisor for Tarsus. "The study underscores the importance of identifying the disease sooner, as well as the need for a safe, effective therapy that may provide substantial relief to this patient population. Tarsus is committed to progressing their clinical program in this area to develop a therapy that may address the underlying cause of Demodex blepharitis."
The Atlas study surveyed 311 patients who were pre-screened at 8 sites participating in Tarsus' pivotal Phase 2b/3 Saturn-1 trial. Patients had three objective signs of Demodex blepharitis, including the presence of Demodex mites; presence of collarettes on the lashes, also known as cylindrical dandruff, which are a pathognomonic sign of Demodex blepharitis; and lid margin erythema. Patients were asked questions about ocular symptoms, diagnoses, and history and their questionnaire responses were analyzed. The study found that the functional and psychosocial burdens of Demodex blepharitis are considerable, leading patients to seek treatment and medical care, mostly unsuccessfully:
- More than half of patients (51%) said they had signs and symptoms of blepharitis for at least four years, but most (58%) reported they had never been diagnosed, even though a third had made at least two and sometimes more than six visits to a doctor seeking relief.
- Patients reported their most bothersome symptoms were itchy eyes and dry eyes, with the majority (52%) experiencing these symptoms frequently or all the time in the past month.
- Many patients said they were emotionally affected, with almost half (47%) conscious of their eyes all day, nearly a quarter (23%) constantly worrying about their eyes and 23% saying it gave their eyes or eyelids a negative appearance to others.
- The disease also affected their daily activities, with almost half (47%) reporting difficulty driving at night and nearly a third (30%) saying it added time to their daily hygiene routine.
- Most patients (81%) had sought treatment, but many of these patients discontinue treatment, citing ineffectiveness, tolerability, or other reasons.
"The Atlas study reveals the need for a proven treatment for Demodex blepharitis to treat patients' disease and end the daily toll it takes on their ocular health and quality of life," said Bobak Azamian, M.D., Ph.D., President and Chief Executive Officer of Tarsus. "Our goal is to offer patients and eye care professionals the first drug treatment that targets the underlying cause of disease, and may positively impact the significant disease burden. We remain focused on advancing our pivotal TP-03 clinical program and we look forward to initiating Saturn-2 this quarter and announcing the results of Saturn-1 this summer."
Tarsus also presented the complete findings of the Europa study, a prospective, randomized, vehicle-controlled Phase 2b trial that evaluated the safety and efficacy of twice-daily TP-03, topical lotilaner ophthalmic solution 0.25%, in adult patients with Demodex blepharitis. Enrolled participants received no treatment for blepharitis symptoms (i.e., lid hygiene) during the study, as well as at least 14 days prior.
- In the trial, TP-03 demonstrated statistically significant results for the primary endpoint, collarette cure over vehicle, which was achieved in 80% of patients versus 16%, respectively, at 42 days (p<0.001).
- Furthermore, TP-03 demonstrated statistically significant results for the secondary endpoints. Mites were eradicated in 73% of patients treated with TP-03 compared to 21% of the vehicle group (p=0.003) and composite collarette and erythema cure was achieved in 73% of patients treated with TP-03 compared to 11% of the vehicle group, both at 42 days (p<0.001).
- In post hoc analyses, 93% of patients treated with TP-03 had a clinically meaningful outcome of 10 or fewer lashes with collarettes by day 42.
- Additional post-hoc analyses showed that 87% of patients treated with TP-03 had mite density reduced by 50% or more by day 14.
- There were no serious adverse events and no discontinuations due to adverse events.
The positive results observed in the Europa study were used as the basis for the pivotal Phase 2b/3 Saturn-1 and Phase 3 Saturn-2 trials of TP-03 to treat Demodex blepharitis.
About TP-03
TP-03 (lotilaner ophthalmic solution, 0.25%) is a novel, investigational therapeutic designed to target and eradicate Demodex mites. It is a potent, non-competitive antagonist of insect and arachnid GABA-Cl channels and a highly lipophilic molecule, which may promote its uptake in the oily sebum of the hair follicle where the mites reside. Tarsus has completed four Phase 2 clinical trials of TP-03 in Demodex blepharitis, all of which met their respective endpoints with no significant adverse events nor any events leading to treatment discontinuation. TP-03 is currently being evaluated in the Saturn-1 pivotal Phase 2b/3 trial. If approved, TP-03 may offer treatment for millions of patients around the world with Demodex blepharitis.About Demodex Blepharitis
Blepharitis is a common ocular condition that is characterized by inflammation of the eyelid margin, redness and ocular irritation. Demodex blepharitis is caused by infestation of Demodex mites, the most common ectoparasite found on humans. Demodex mites cause approximately 45% of blepharitis, or about 9 million cases in the US and the number may be as high as approximately 25 million based on Tarsus' internal research indicating about 58% of patients presenting to eye care clinics have collarettes, a pathognomonic sign of Demodex infestation, and a published study estimating that at least 45 million people annually visit an eye care clinic. Currently, there are no FDA-approved treatments for Demodex blepharitis.About Tarsus Pharmaceuticals, Inc.
Tarsus Pharmaceuticals, Inc. is a late clinical-stage biopharmaceutical company that applies proven science and new technology to revolutionize treatment for patients, starting with eye care. It is advancing its pipeline to address several diseases with high unmet need across a range of therapeutic categories, including eye care, dermatology, and infectious disease prevention. Its lead product candidate, TP-03, is a novel therapeutic in a pivotal Phase 2b/3 trial for the treatment of Demodex blepharitis. TP-03 is also being developed for the treatment of Meibomian Gland Disease.Forward-Looking Statements
Statements in this press release about future expectations, plans and prospects, as well as any other statements regarding matters that are not historical facts, may constitute "forward-looking statements." These statements include statements regarding the market size for TP-03, future events and Tarsus' plans for and the anticipated benefits of its product candidates including TP-03, the timing, objectives and results of the clinical studies and anticipated regulatory and development milestones and the quotations of Tarsus' management. The words, without limitation, "believe," "contemplate," "continue," "could," "estimate," "expect," "intend," "may," "might," "plan," "potential," "predict," "project," "should," "target," "will" or "would" or the negative of these terms or other similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these or similar identifying words. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors. Important factors that could cause actual results to differ materially from those in the forward-looking statements include: Tarsus has incurred significant losses and negative cash flows from operations since inception and anticipates that it will continue to incur significant expenses and losses for the foreseeable future; Tarsus may need to obtain additional funding to complete the development and any commercialization of its product candidates, if approved; Tarsus is heavily dependent on the success of its lead product candidate, TP-03 for the treatment of Demodex blepharitis; the COVID-19 pandemic may affect Tarsus' ability to initiate and complete preclinical studies and clinical trials, disrupt regulatory activities, disrupt manufacturing and supply chain or have other adverse effects on Tarsus' business and operations; even if TP-03 or any other product candidate that Tarsus develops receives marketing approval, Tarsus may not be successful in educating eye care physician and the market about the need for treatments specifically for Demodex blepharitis and or other diseases or conditions targeted by Tarsus' products; the development and commercialization of Tarsus products is dependent on intellectual property it licenses from Elanco Tiergesundheit AG; Tarsus will need to develop and expand the company and Tarsus may encounter difficulties in managing its growth, which could disrupt its operations; the sizes of the market opportunity for Tarsus' product candidates, particularly TP-03 for the treatment of Demodex blepharitis and MGD, have not been established with precision and may be smaller than estimated; the results of Tarsus' earlier studies and trials may not be predictive of future results; any termination or suspension of, or delays in the commencement or completion of, Tarsus' planned clinical trials could result in increased costs, delay or limit its ability to generate revenue and adversely affect its commercial prospects; and if Tarsus is unable to obtain and maintain sufficient intellectual property protection for its product candidates, or if the scope of the intellectual property protection is not sufficiently broad, Tarsus' competitors could develop and commercialize products similar or identical Tarsus' product. Further, there are other risks and uncertainties that could cause actual results to differ from those set forth in the forward-looking statement and they are detailed from time to time in the reports Tarsus files with the Securities and Exchange Commission, including Tarsus' Form 10-K for the year ended December 31, 2020 filed with the SEC on March 31, 2021, which Tarsus incorporates by reference into this press release, copies of which are posted on its website and are available from Tarsus without charge. However, new risk factors and uncertainties may emerge from time to time, and it is not possible to predict all risk factors and uncertainties. Accordingly, readers are cautioned not to place undue reliance on these forward-looking statements. Any forward-looking statements contained in this press release are based on the current expectations of Tarsus' management team and speak only as of the date hereof, and Tarsus specifically disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events or otherwise.Contacts:
Media Contact:
SuJin Oh
Shop PR
(917) 841-5213
[email protected]Investor Contact:
Patti Bank
Westwicke Partners, an ICR company
(415) 513-1284
[email protected] -
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IRVINE, Calif., April 27, 2021 (GLOBE NEWSWIRE) -- Tarsus Pharmaceuticals, Inc. (NASDAQ:TARS), a late clinical-stage biopharmaceutical company whose mission is to focus on unmet needs and apply proven science and new technology to revolutionize treatment for patients, starting with eye care, today announced Bobak Azamian, M.D., Ph.D., President and Chief Executive Officer of Tarsus, will present an overview of the company at the BofA Securities 2021 Virtual Health Care Conference. In addition to the presentation, the management team will host investor meetings at the conference.
Presentation Details
Date: Wednesday, May 12
Time: 5:00 PM ET/ 2:00 PM PT
Webcast: https://www.veracast.com/webcasts/bofa/hc2021/id5V4C40.cfmThe live webcast will be hosted on ir.tarsusrx.com and available for replay for a period of 90 days.
About Tarsus Pharmaceuticals, Inc.
Tarsus Pharmaceuticals, Inc. is a late clinical-stage biopharmaceutical company that applies proven science and new technology to revolutionize treatment for patients, starting with eye care. It is advancing its pipeline to address several diseases with high unmet need across a range of therapeutic categories, including eye care, dermatology, and infectious disease prevention. Its lead product candidate, TP-03, is a novel therapeutic in a pivotal Phase 2b/3 trial for the treatment of Demodex blepharitis. TP-03 is also being developed for the treatment of Meibomian Gland Disease.Forward-Looking Statements
Statements in this press release about future expectations, plans and prospects, as well as any other statements regarding matters that are not historical facts, may constitute "forward-looking statements." These statements include statements regarding the market size for TP-03, future events and Tarsus' plans for and the anticipated benefits of its product candidates including TP-03, the timing, objectives and results of the clinical studies and anticipated regulatory and development milestones and the quotations of Tarsus' management. The words, without limitation, "believe," "contemplate," "continue," "could," "estimate," "expect," "intend," "may," "might," "plan," "potential," "predict," "project," "should," "target," "will" or "would" or the negative of these terms or other similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these or similar identifying words. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors. Important factors that could cause actual results to differ materially from those in the forward-looking statements include: Tarsus has incurred significant losses and negative cash flows from operations since inception and anticipates that it will continue to incur significant expenses and losses for the foreseeable future; Tarsus may need to obtain additional funding to complete the development and any commercialization of its product candidates, if approved; Tarsus is heavily dependent on the success of its lead product candidate, TP-03 for the treatment of Demodex blepharitis; the COVID-19 pandemic may affect Tarsus' ability to initiate and complete preclinical studies and clinical trials, disrupt regulatory activities, disrupt manufacturing and supply chain or have other adverse effects on Tarsus' business and operations; even if TP-03 or any other product candidate that Tarsus develops receives marketing approval, Tarsus may not be successful in educating eye care physician and the market about the need for treatments specifically for Demodex blepharitis and or other diseases or conditions targeted by Tarsus' products; the development and commercialization of Tarsus products is dependent on intellectual property it licenses from Elanco Tiergesundheit AG; Tarsus will need to develop and expand the company and Tarsus may encounter difficulties in managing its growth, which could disrupt its operations; the sizes of the market opportunity for Tarsus' product candidates, particularly TP-03 for the treatment of Demodex blepharitis and MGD, have not been established with precision and may be smaller than estimated; the results of Tarsus' earlier studies and trials may not be predictive of future results; any termination or suspension of, or delays in the commencement or completion of, Tarsus' planned clinical trials could result in increased costs, delay or limit its ability to generate revenue and adversely affect its commercial prospects; and if Tarsus is unable to obtain and maintain sufficient intellectual property protection for its product candidates, or if the scope of the intellectual property protection is not sufficiently broad, Tarsus' competitors could develop and commercialize products similar or identical Tarsus' product. Further, there are other risks and uncertainties that could cause actual results to differ from those set forth in the forward-looking statement and they are detailed from time to time in the reports Tarsus files with the Securities and Exchange Commission, including Tarsus' Form 10-K for the year ended December 31, 2020 filed with the SEC on March 31, 2021, which Tarsus incorporates by reference into this press release, copies of which are posted on its website and are available from Tarsus without charge. However, new risk factors and uncertainties may emerge from time to time, and it is not possible to predict all risk factors and uncertainties. Accordingly, readers are cautioned not to place undue reliance on these forward-looking statements. Any forward-looking statements contained in this press release are based on the current expectations of Tarsus' management team and speak only as of the date hereof, and Tarsus specifically disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events or otherwise.Media Contact:
SuJin Oh
Shop PR
(917) 841-5213
[email protected]
Investor Contact:
Patti Bank
Westwicke Partners, an ICR company
(415) 513-1284
[email protected]