About Us | ScientistTARS Tarsus Pharmaceuticals Inc.
Upcoming Catalysts
| Drug | Stage | Catalyst Date |
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TP-03 (Saturn-2)
Demodex Blepharitis
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Phase 3
Phase 3
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Drug Pipeline
| Drug | Stage | Notes |
|---|---|---|
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TP-03 - Saturn-1
Demodex Blepharitis
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Phase 2/3
Phase 2/3
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Phase 2b/3 top-line data released June 21, 2021. Endpoints met.
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TP-05
Healthy volunteers / Lyme disease
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Phase 1
Phase 1
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Phase 1 trial initiation announced June 16, 2021.
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Latest News
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Announced positive results of the Saturn-1 pivotal trial evaluating TP-03 for the treatment of Demodex blepharitis; results presented at the 2021 American Society of Cataract and Refractive Surgery (ASCRS) conference
Initiated Saturn-2, second pivotal Phase 3 trial evaluating the safety and efficacy of TP-03 for the treatment of Demodex blepharitis; Saturn-2 trial design similar to Saturn-1, topline data expected in Q1 2022
Initiated the Phase 1 Callisto trial evaluating TP-05, a novel, oral, non-vaccine therapeutic, for the prevention of Lyme disease
Cash and equivalents of $177 million, plus TP-03 license receivables of $20 million as of June 30, 2021
IRVINE, Calif., Aug. 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 financial results and provided business and clinical updates for the quarter ended June 30, 2021.
"We have achieved significant milestones on our lead product and pipeline so far in 2021 with the positive read-out of the Saturn-1 data for TP-03 in Demodex blepharitis, the initiation of Saturn-2, and the initiation of the Callisto trial of TP-05 for the prevention of Lyme disease," said Bobak Azamian, M.D., Ph.D., President and Chief Executive Officer of Tarsus. "Interest from the physician community also continues to build, as new Saturn-1 data presented at the ASCRS 2021 Annual Meeting reinforced the strong potential clinical utility of TP-03 with a broad range of patients showing a substantial response. Additionally, results from the Titan and Atlas studies reinforce the prevalence and burden of Demodex blepharitis, suggesting that this disease could affect as many as 25 million Americans, with 80% of patients reporting a negative impact on daily life. We believe this data supports both the need and opportunity for an FDA-approved therapeutic treatment option."
Recent Business Highlights and Corporate Update:
- Announced positive results of the Phase 2b/3 Saturn-1 pivotal trial studying TP-03 (lotilaner ophthalmic solution, 0.25%) in patients with Demodex blepharitis. All pre-specified primary and secondary endpoints were met, and complete resolution of Demodex blepharitis signs was demonstrated in many patients treated with TP-03 (lotilaner ophthalmic solution, 0.25%).
- 81% of patients on TP-03 achieved a clinically meaningful collarette cure, defined as 0-10 collarettes per lid at day 43 compared to 23% of those on vehicle (p<0.0001).
- 44% of patients on TP-03 achieved the primary endpoint of complete collarette cure, defined as 0-2 collarettes per lid at day 43, compared to 7% on vehicle (p<0.0001).
- 68% of patients on TP-03 achieved mite eradication defined as 0 mites per lash at day 43, compared to 18% on vehicle (p<0.0001).
- Additionally, significant efficacy in lid erythema (redness) was demonstrated across multiple measures including complete and clinically meaningful composite cures, and in erythema alone. Results showed 45% of patients improved erythema by one (1) grade or more (compared to 28% of patients on vehicle, p=0.0002) and 19% of patients on TP-03 achieved a complete erythema cure (compared to 7% of patients on vehicle, p<0.0001).
- TP-03 was well tolerated with a safety profile similar to the vehicle group. Additionally, the vast majority of TP-03 patients (92%) reported that the drop comfort was neutral to very comfortable. There were no serious treatment-related adverse events nor any treatment-related adverse events leading to treatment discontinuation.
- 81% of patients on TP-03 achieved a clinically meaningful collarette cure, defined as 0-10 collarettes per lid at day 43 compared to 23% of those on vehicle (p<0.0001).
- Released new data from the Saturn-1 Phase 2b/3 pivotal trial at the ASCRS 2021 Annual Meeting. The new Saturn-1 data reinforces the strong potential clinical utility of TP-03 for the treatment of Demodex blepharitis, with a broad range of patients showing a substantial response.
- 95% of TP-03 patients showed a significant improvement in mite count, achieving ≤0.5 mites per lash at day 43 from an average baseline of 3.2 mites per lash, compared to 36% of those on vehicle (p<0.0001).
- 93% of TP-03 patients improved by at least one collarette grade or approximately 50 collarettes per lid by day 43, from an average baseline of grade 2.8 or approximately 100 collarettes per lid, compared to 50% of those on vehicle (p<0.0001).
- An additional Saturn-1 safety analysis also revealed that TP-03 had no clinically significant effect on multiple safety measures including Corrected Distance Visual Acuity (CDVA), corneal staining, and intraocular pressure (IOP), and no significant findings from slit lamp biomicroscopy or fundus exam. In addition, no impact to endothelial cell density (ECD) was seen in a subset of 21 patients. ECD will be further evaluated as part of the Saturn-2 trial plan.
- 95% of TP-03 patients showed a significant improvement in mite count, achieving ≤0.5 mites per lash at day 43 from an average baseline of 3.2 mites per lash, compared to 36% of those on vehicle (p<0.0001).
- Presented data from the Titan real world prevalence study at the ASCRS meeting. The Titan study is an IRB-approved, retrospective chart review of 1,032 patients across six U.S.-based ophthalmology and optometry practices, designed to better understand the prevalence of collarettes in U.S. eye care clinics. Collarettes, or cylindrical dandruff, are a pathognomonic sign of Demodex blepharitis and are an accumulation of mite waste product and eggs that form at the base of the eyelashes. In data presented at ASCRS, the Titan study revealed the presence of collarettes in 58% (n=595) of patients. When projected across the U.S. population, these results suggest that Demodex blepharitis could affect as many as 25 million Americans. The study also revealed that the prevalence of Demodex blepharitis is similar to that of dry eye (58%, n=593).
- Commenced enrollment in Saturn-2, the second pivotal trial evaluating TP-03 for the treatment of Demodex blepharitis. Saturn-2 is a randomized, controlled, multicenter, double-masked trial studying the safety and efficacy of TP-03. The trial is expected to enroll 418 participants and has a similar design to Saturn-1. Saturn-2's primary endpoint is the proportion of patients achieving collarette cure, defined as 0 to 2 collarettes per lid. 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). Topline results for the study are anticipated in Q1 of 2022.
- Initiated the Phase 1 Callisto trial of TP-05, a novel, oral, non-vaccine therapeutic, for the prevention of Lyme disease and malaria. The Phase 1 Callisto trial is a single ascending dose and multiple ascending dose trial designed to evaluate the safety, tolerability, and pharmacokinetics (PK) of TP-05 in healthy volunteers. There are currently no U.S. Food and Drug Administration (FDA)-approved pharmacological prophylactic options for Lyme disease, which is the most common vector-borne disease in the United States, transmitted to humans through the infection of the bacterium Borrelia burgdorferi following the bite of a tick vector.
- Presented data from the Atlas study at the virtual Association for Research in Vision and Ophthalmology (ARVO) 2021 Annual Meeting. The Atlas study is believed to be 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.
- Received $35 million in proceeds as part of the partnership with LianBio; an additional $20 million is expected in Q3 2021 for clinical milestones achieved in June 2021.
Second Quarter 2021 Financial Results
- Second quarter net income for 2021 was $6.3 million, compared to a net loss of $(3.3) million for the same period in 2020.
- Second quarter 2021 license fee and collaboration revenue, as part of strategic partnership with LianBio, was $22.0 million; and $0.7 million in associated expense in proportion to this revenue.
- Second quarter research and development expenses for 2021 were $7.2 million (inclusive of stock-based compensation of $0.4 million), compared to $1.7 million for the same period in 2020.
- Second quarter general and administrative expenses for 2021 increased to $6.8 million (inclusive of stock-based compensation of $2.4 million), compared to $1.5 million for the same period in 2020.
- As of June 30, 2021, cash and cash equivalents were $176.7 million, and accounts receivable were $20 million for an achieved TP-03 clinical milestone.
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. The Company is studying two investigational medicines in clinical trials. Its lead product candidate, TP-03, is a novel therapeutic being studied in a second Phase 3 pivotal trial for the treatment of Demodex blepharitis. TP-03 is also being developed for the treatment of Meibomian Gland Disease. Tarsus is developing TP-05, an oral, non-vaccine therapeutic for the prevention of Lyme disease, which is currently being studied in a Phase 1 clinical trial.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, and Form 10-Q for the quarter ended June 30, 2021 filed with the SEC on August 4, 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
June 30,Six Months Ended
June 30,2021 2020 2021 2020 Revenues: License fees $ 19,048 — $ 52,359 — Collaboration revenue 2,969 — 3,090 — Total revenues 22,017 — 55,449 — Operating expenses: Cost of license fees and collaboration revenue 737 — 2,034 — Research and development 7,204 1,737 23,465 3,249 General and administrative 6,794 1,526 11,954 2,132 Total operating expenses 14,735 3,263 37,453 5,381 Income (loss) from operations before other (expense) income and income taxes 7,282 (3,263 ) 17,996 (5,381 ) Other (expense) income: Interest income (expense), net 7 13 16 174 Other (expense) income, net (39 ) — (73 ) — Change in fair value of equity warrant rights (876 ) — (876 ) — Total other (expense) income (908 ) 13 (933 ) 174 Provision for income taxes (29 ) — (342 ) — Net income (loss) and comprehensive income (loss) $ 6,345 $ (3,250 ) $ 16,721 $ (5,207 ) Net income (loss) per share Basic $ 0.31 $ (1.23 ) $ 0.81 $ (1.96 ) Diluted $ 0.29 $ (1.23 ) $ 0.76 $ (1.96 ) Weighted-average shares outstanding Basic 20,555,258 2,651,321 20,446,246 2,650,843 Diluted 21,966,599 2,651,321 21,895,304 2,650,843 TARSUS PHARMACEUTICALS, INC.
BALANCE SHEETS
(In thousands, except share and par value amounts)June 30, 2021 December 31, 2020 (unaudited) ASSETS Current assets: Cash and cash equivalents $ 176,735 $ 168,129 Restricted cash — 20 Accounts receivable 20,000 — Other receivables 157 20 Prepaid expenses and other current assets 4,012 2,486 Total current assets 200,904 170,655 Property and equipment, net of accumulated depreciation 481 548 Operating lease right-of-use asset 540 688 Other assets 1,525 81 Total assets $ 203,450 $ 171,972 LIABILITIES, PREFERRED STOCK AND STOCKHOLDERS' EQUITY Current liabilities: Accounts payable and other accrued liabilities $ 8,985 $ 4,347 Accrued payroll and benefits 1,470 1,040 Total current liabilities 10,455 5,387 Other long-term liabilities 524 605 Total liabilities 10,979 5,992 Commitments and contingencies (Note 9) Stockholders' equity: Preferred stock, $0.0001 par value; 10,000,000 authorized at June 30, 2021 and December 31, 2020; no shares issued and outstanding at June 30, 2021 and December 31, 2020 — — Common stock, $0.0001 par value; 200,000,000 shares authorized; 20,704,104 shares issued and 20,573,951 outstanding, which excludes 130,153 shares subject to repurchase at June 30, 2021 (unaudited); 20,502,576 shares issued and 20,323,301 outstanding, which excludes 179,375 shares subject to repurchase at December 31, 2020 4 4 Additional paid-in capital 208,591 198,821 Accumulated deficit (16,124 ) (32,845 ) Total stockholders' equity 192,471 165,980 Total liabilities, preferred stock and stockholders' equity $ 203,450 $ 171,972 
- Announced positive results of the Phase 2b/3 Saturn-1 pivotal trial studying TP-03 (lotilaner ophthalmic solution, 0.25%) in patients with Demodex blepharitis. All pre-specified primary and secondary endpoints were met, and complete resolution of Demodex blepharitis signs was demonstrated in many patients treated with TP-03 (lotilaner ophthalmic solution, 0.25%).
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New Saturn-1 data demonstrated a strong patient responder rate with 95% of Demodex blepharitis patients treated with TP-03 achieving ≤0.5 mites per lash and 93% improving by at least one collarette grade
Further Saturn-1 safety analysis revealed that TP-03 had a favorable safety profile with no clinically significant effect on multiple measures
Titan study reveals the high real-world prevalence of Demodex blepharitis, with collarettes present in 58% of U.S. patients visiting an eye doctor
IRVINE, Calif., July 24, 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 new data from its Saturn-1 Phase 2b/3 pivotal trial and the Titan real-world collarette prevalence study at the American Society of Cataract and Refractive Surgery (ASCRS) 2021 Annual Meeting. The new Saturn-1 data reinforce the strong potential clinical utility of TP-03 (lotilaner ophthalmic solution, 0.25%) for the treatment of Demodex blepharitis, with a broad range of patients showing a substantial response. The Titan study revealed the high prevalence of Demodex blepharitis in all-comer eye care patients in the U.S. across diverse populations and geographies, including significant overlap with some of the most commonly seen patients, such as those taking prescription dry eye treatments.
"We are very encouraged by the additional Saturn-1 data points, demonstrating that nearly all patients experienced a substantial response, and the clinical value that TP-03 may have for both patients and eye care professionals who have long struggled to manage Demodex blepharitis – a disease with no existing approved therapies," said Bobak Azamian, M.D., Ph.D., President and Chief Executive Officer of Tarsus. "We have received a lot of enthusiasm and positive feedback on this new data from clinicians at the ASCRS meeting. The compelling results of the Saturn-1 trial mark an important step in our clinical program for TP-03 and bring us one step closer to the development of a much-needed therapy for patients suffering from this disease. Our second pivotal trial, Saturn-2 is currently enrolling. If the topline results expected in Q1 2022 are positive, we expect to submit a New Drug Application next year for TP-03 for the treatment of Demodex blepharitis."
Additional Saturn-1 Phase 2b/3 Results & Safety Data
New Saturn-1 data presented at ASCRS today, demonstrated that, in addition to achieving all primary and secondary endpoints, the results showed a strong patient responder rate, as nearly all Demodex blepharitis patients experienced a significant response to treatment with TP-03. These findings indicate the substantial potential impact this treatment may have for both patients and eye care professionals. Results showed meaningful improvement in the number of mites per lash as well as collarette grade reduction:
- 95% of TP-03 patients showed a significant response in mite count, achieving ≤0.5 mites per lash at day 43 from an average baseline of 3.2 mites per lash, compared to 36% of those on vehicle (p<0.0001), with statistically significant results seen as early as day 15.
- 93% of TP-03 patients improved by at least one collarette grade by day 43, from an average baseline of grade 2.8 or approximately 100 collarettes per lid, compared to 50% of those on vehicle (p<0.0001), with statistically significant results seen as early as day 8.
In addition to the data presented at the ASCRS meeting, Tarsus is also announcing results from additional Saturn-1 safety analysis, which revealed that TP-03 had no clinically significant effect on multiple safety measures including Corrected Distance Visual Acuity (CDVA), corneal staining, and intraocular pressure (IOP) and no significant findings from slit lamp biomicroscopy or fundus exam. In addition, no impact to endothelial cell density (ECD) was seen in a subset of 21 patients. ECD will be further evaluated as part of the Saturn-2 trial plan. Analysis from Saturn-1, along with previously announced data, reinforces that TP-03 is potentially safe to use in a broad patient population.
Saturn-1 (Phase 2b/3) was a randomized, controlled, multicenter, double-masked pivotal trial evaluating the safety and efficacy of TP-03 in adults with Demodex blepharitis. Previously announced Saturn-1 topline data showed that TP-03 met all its primary and secondary endpoints, including improvements in lid margin redness, with no serious treatment-related adverse events and no treatment-related discontinuations.
The Saturn-1 trial was the first pivotal large-scale trial to show positive, clinically meaningful and statistically significant patient improvements for a therapeutic specifically designed to treat Demodex blepharitis. TP-03 has the potential to be the first U.S. Food and Drug Administration (FDA)-approved therapeutic for Demodex blepharitis that targets the underlying cause of disease – Demodex mite infestation.
Tarsus is currently proceeding with the second pivotal trial, the Saturn-2 (Phase 3) trial, which has the same primary and secondary endpoints as Saturn-1 and is expected to report topline data results in Q1 2022.
Titan Study Results
The Titan study is an IRB-approved, retrospective chart review of 1,032 patients across six U.S.-based ophthalmology and optometry practices by seven investigators, designed to better understand the prevalence of collarettes in U.S. eye care clinics. Collarettes, or cylindrical dandruff, are a pathognomonic sign of Demodex blepharitis and are an accumulation of mite waste product and eggs that form at the base of the eyelashes. In data presented at ASCRS, the Titan study revealed the presence of collarettes in 58% (n=595) of patients. These results indicate a high prevalence of Demodex blepharitis across diverse patient populations and geographies. The study also revealed that the prevalence of Demodex blepharitis is similar to that of dry eye (58%, n=593).
"The Titan findings are significant and help to quantify how prevalent Demodex blepharitis is in real-life clinical practice, with more than half of observed patients presenting with collarettes," said Ehsan Sadri, M.D., FACS, CEO and Founder of Visionary Eye Institute, Newport Beach and Titan study presenter at ASCRS. "The study also showed that collarettes are easy to identify through a close evaluation of the upper eyelid when patients are looking down during an eye exam. I look forward to the potential of a new, effective treatment option that can provide relief for this disease which impacts so many of my patients."
The Titan study also found that most blepharitis patients (69%) had collarettes, underscoring the role that Demodex mites play in blepharitis cases. Additionally, 60% (n=135) of patients who were on a dry eye prescription also had collarettes. Analysis of these data suggest that these patients may have concomitant disease or that Demodex blepharitis may be the root cause or an exacerbating factor of their dry eye disease.
The Titan study findings are further supported by a prospective independent study presented at ARVO 2021 (Teo et al), which found that demodicosis was newly diagnosed in 55.3% of patients, with 61.8% and 68.3% noted to have blepharitis and dry eye, respectively.
Archived videos of the ASCRS presentations can be accessed via the following links:
- Safety and Efficacy of Topical Lotilaner, 0.25% for the Treatment of Demodex Blepharitis: Results of the Phase 2b/3 Saturn-1 Trial
- The Prevalence of Collarettes and Demodex Blepharitis in Ophthalmology and Optometry Practices
About TP-03
TP-03 (lotilaner ophthalmic solution, 0.25%) is a novel, investigational therapeutic designed to resolve the signs of Demodex blepharitis by targeting and eradicating the root cause of the disease – Demodex mite infestation. TP-03 is a topical ophthalmic formulation of lotilaner, which is a well-characterized anti-parasitic agent that paralyzes and eradicates Demodex mites by selectively inhibiting parasite-specific GABA-Cl channels. 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. TP-03 was evaluated in the pivotal Saturn-1 (Phase 2b/3) trial involving 421 patients and met all primary and secondary endpoints with no serious treatment-related adverse events and no treatment-related discontinuations. Prior to that, Tarsus also 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-2 (Phase 3) pivotal 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 blepharitis may affect as many as 25 million Americans based on an extrapolation from the Titan study indicating 58% of patients presenting to U.S. eye care clinics have collarettes, a pathognomonic sign of Demodex infestation, and another published study estimating that at least 45 million people annually visit an eye care clinic. Demodex blepharitis can have a significant clinical burden and negatively impact patients' daily lives. 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. The company is studying two investigational medicines in clinical trials. Its lead product candidate, TP-03, is a novel therapeutic being studied in a second Phase 3 pivotal trial for the treatment of Demodex blepharitis. TP-03 is also being developed for the treatment of Meibomian Gland Disease. Tarsus is developing TP-05, an oral, non-vaccine therapeutic for the prevention of Lyme disease, which is currently being studied in a Phase 1 clinical trial.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 includes statements regarding Tarsus' plans for and the anticipating benefits of its product candidates, including TP-03, the timing, objectives and results of the clinical trials and anticipated regulatory and development milestones, including the timing of the Saturn-2 clinical trial and submission of an NDA, 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 and Form 10-Q for the quarter ended March 31, 2021 filed with the SEC on May 11, 2021, which Tarsus incorporates by reference into this press release and 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., July 07, 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 provide a brief corporate update at the Ladenburg Thalmann 2021 Virtual Healthcare Conference.
Presentation Details
Date: Wednesday, July 14
Time: 1:30 PM ET/10:30 AM PT
Webcast: https://wsw.com/webcast/ladenburg7/tars/2438302The 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. The company is studying two investigational medicines in clinical trials. Its lead product candidate, TP-03, is a novel therapeutic being studied in a second Phase 3 pivotal trial for the treatment of Demodex blepharitis. TP-03 is also being developed for the treatment of Meibomian Gland Disease. Tarsus is developing TP-05, an oral, non-vaccine therapeutic for the prevention of Lyme disease, which is currently being studied in a Phase 1 clinical trial.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., June 22, 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 provide a brief corporate update during a fireside chat at the Raymond James 2021 Human Health Innovation Conference.
Fireside Chat Details
Date: Tuesday, June 22
Time: 12:00 PM ET/ 9:00 AM PT
Webcast: https://kvgo.com/rj-health/tarsus-pharmaceuticals-inc-june-2021The 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. The company is studying two investigational medicines in clinical trials. Its lead product candidate, TP-03, is a novel therapeutic being studied in a second Phase 3 pivotal trial for the treatment of Demodex blepharitis. TP-03 is also being developed for the treatment of Meibomian Gland Disease. Tarsus is developing TP-05, an oral, non-vaccine therapeutic for the prevention of Lyme disease, which is currently being studied in a Phase 1 clinical trial.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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Saturn-1 Phase 2b/3 trial met all primary and secondary endpoints, and demonstrated significant, clinically meaningful outcomes with no serious treatment-related adverse events and no treatment-related discontinuations, demonstrating the potential of TP-03 to treat Demodex blepharitis, a disease with no FDA-approved therapies
As many as 25 million Americans may have Demodex blepharitis, an ocular disease that can have a significant clinical burden and negatively impact patients' daily lives
Conference call and webcast scheduled for today at 8:00 a.m. ET to review detailed topline Saturn-1 data
IRVINE, Calif., June 21, 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 all pre-specified primary and secondary endpoints were met for its pivotal Phase 2b/3 Saturn-1 trial evaluating the company's novel investigational therapeutic, TP-03 (lotilaner ophthalmic solution, 0.25%), in patients with Demodex blepharitis. Results demonstrated a statistically significant complete collarette cure at day 43 in patients with Demodex blepharitis treated with TP-03 compared to vehicle (p<0.0001; primary endpoint). The Saturn-1 trial also met the secondary endpoints of mite eradication at day 43 (p<0.0001) and composite cure based on complete collarette and erythema cures at day 43 (p<0.0001). In addition, significant, clinically meaningful improvements were observed within two weeks across multiple endpoints. TP-03 was well tolerated with a safety profile similar to vehicle, and there were no treatment-related discontinuations.
"Millions of people are living with Demodex blepharitis, and we know from recent research that these patients are suffering daily. With no U.S. Food and Drug Administration (FDA)-approved therapies, both patients and eye care professionals need a solution to eradicate the mites that cause the disease," said Bobak Azamian, M.D., Ph.D., President and Chief Executive Officer of Tarsus. "We believe the results from our Saturn-1 trial mark an important moment in Demodex blepharitis research, showing the potential of TP-03 to target the underlying cause of this disease and potentially become the standard of care for patients and clinicians. We expect to provide topline results for our second pivotal trial for TP-03, Saturn-2, in Q1 of 2022. If Saturn-2 trial data is positive, similar to the positive Saturn-1 results, we expect both Saturn-1 and Saturn-2 trials to support our submission of a New Drug Application (NDA) for TP-03 for the treatment of Demodex blepharitis in 2022."
Demodex blepharitis is a highly prevalent ocular disease, affecting as many as 25 million Americans, that can have a significant clinical burden and negatively impact patients' daily lives. The disease is caused by an infestation of Demodex mites, the most common ectoparasite found on humans, that live on the skin of the face and eyelids. Demodex blepharitis is characterized by inflammation of the eyelid margin, redness and ocular irritation. TP-03 has the potential to be the first FDA-approved therapeutic for Demodex blepharitis and targets the underlying cause of disease – Demodex mite infestation. The Saturn-1 trial is the first large-scale trial to show positive, clinically meaningful results for a therapeutic specifically designed to treat Demodex blepharitis.
Saturn-1 Phase 2b/3 Results
Results demonstrated 81% of patients achieved a significant, clinically meaningful collarette cure defined by a collarette grade of zero (0) or one (1) at day 43 compared to 23% of those on vehicle (p<0.0001). Additionally, a significant, clinically meaningful collarette cure was seen in 23% of patients on TP-03 compared to 11% on vehicle as early as day 8 (p=0.0003). Saturn-1 data also showed that 43% of patients on TP-03 achieved the primary endpoint of complete collarette cure (grade 0) at day 43, defined as zero to two (0-2) collarettes per lid compared to 7% on vehicle (p<0.0001). Collarettes, a pathognomonic sign of Demodex infestation, are composed of partially digested epithelial cells, mite waste products and eggs and are most easily observed at the base of the upper eyelashes when the patient looks down during a standard eye examination.
The secondary endpoint of complete mite eradication achieved statistically significant results by day 15, and 68% of patients on TP-03 achieved mite eradication compared to 18% on vehicle (p<0.0001) at day 43. Mite eradication is defined as a mite density of zero (0) mites per lash.
For composite cure, 68% of patients experienced a significant, clinically meaningful cure of both a grade zero (0) or one (1) collarette and erythema score at day 43 compared to 20% on vehicle (p<0.0001), with significant improvements seen as early as day 8. Additionally, 13.4% of patients on TP-03 achieved a complete composite cure, which was another secondary endpoint, based on a composite of collarette cure and erythema cure compared to 1.0% on vehicle (p<0.0001) at day 43. Composite cure is defined as the presence of zero to two (0-2) collarettes on the upper eyelid and the absence of erythema (redness). Results for complete erythema cure (19% of patients on TP-03 compared to 7% of patients on vehicle, p<0.0001) and one (1) grade or more erythema improvement (45% of patients on TP-03 compared to 28% of patients on vehicle, p=0.0002) were also statistically significant.
Trial Safety Data
TP-03 is a well-characterized anti-parasitic agent that paralyzes and eradicates Demodex mites by selectively inhibiting parasite-specific GABA-Cl channels. Saturn-1 trial results demonstrated that TP-03 was well tolerated with a safety profile similar to the vehicle group. Additionally, most TP-03 patients (92%) reported that the drop comfort was neutral to very comfortable. There were no serious treatment-related adverse events nor any treatment-related adverse events leading to treatment discontinuation. All treatment-related ocular adverse events in the TP-03 group were mild with the most common being instillation site pain/burning/stinging (11.8%, n=25). Other adverse events occurring at a rate of ≥1% in the TP-03 group included instillation site pruritis, reduced visual acuity, eye pain and eye discharge, each representing 1.4% (n=3) of patients.
Saturn-1 Phase 2b/3 Trial Design
Saturn-1 was a randomized, controlled, multicenter, double-masked trial evaluating the safety and efficacy of TP-03 in adults with Demodex blepharitis. The trial enrolled 421 adults aged 18 and over having more than 10 collarettes on the upper lid and at least mild erythema of the upper eyelid margin. Each patient had at least 1.5 mites per lash on the upper and lower eyelids combined. One drop of TP-03 was self-administered twice per day in each eye for six weeks and patients were instructed not to touch or rub their lid margin. Enrolled patients received no treatment for blepharitis symptoms (i.e., lid hygiene) during the trial or 14 days prior to enrollment.
"Demodex blepharitis is a widespread, yet frequently overlooked condition that can negatively impact the quality of life for many patients and lead to more serious health outcomes if left untreated," said Elizabeth Yeu, M.D., Chief Medical Advisor for Tarsus. "I am highly encouraged by the results seen in the Saturn-1 trial and I'm hopeful that there may be a treatment option on the horizon that targets the underlying cause of this disease to help patients finally find relief."
Tarsus is also evaluating TP-03 in its pivotal Saturn-2 (Phase 3) trial, which has the same endpoints as Saturn-1, and commenced patient enrollment in May of 2021. Tarsus expects topline results for the Saturn-2 trial in Q1 2022, and, if the results are similarly positive, Tarsus expects data from both the Saturn-1 and Saturn-2 trials to support submission of a New Drug Application (NDA) to the FDA for TP-03 for the treatment of Demodex blepharitis. TP-03 has the potential to help millions of patients and eye care professionals struggling to manage Demodex blepharitis.
Conference Call and Webcast Information
A detailed summary of the Saturn-1 findings will be presented on a conference call and live, listen-only webcast today at 8:00 a.m. ET. The dial-in numbers are (833) 540-1160 for domestic callers and (929) 517-0351 for international callers. The Conference ID is 3766845. The webcast of the conference call can be accessed at https://edge.media-server.com/mmc/p/uh6zebmu. After the live webcast, the event will remain archived on the Tarsus Pharmaceuticals website at https://ir.tarsusrx.com/ for 90 days.
About TP-03
TP-03 (lotilaner ophthalmic solution, 0.25%) is a novel, investigational therapeutic designed to target and eradicate Demodex mites. TP-03 is a topical ophthalmic formulation of lotilaner, which is a well-characterized anti-parasitic agent that paralyzes and eradicates Demodex mites by selectively inhibiting parasite-specific GABA-Cl channels. 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 was also evaluated in the pivotal Saturn-1 (Phase 2b/3) trial and met all primary and secondary endpoints with no serious treatment-related adverse events and no treatment-related discontinuations. It is currently being evaluated in the Saturn-2 (Phase 3) pivotal 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 U.S. 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. The company is studying two investigational medicines in clinical trials. Its lead product candidate, TP-03, is a novel therapeutic being studied in a second Phase 3 pivotal trial for the treatment of Demodex blepharitis. TP-03 is also being developed for the treatment of Meibomian Gland Disease. Tarsus is developing TP-05, an oral, non-vaccine therapeutic for the prevention of Lyme disease, which is currently being studied in a Phase 1 clinical trial.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 includes statements regarding Tarsus' plans for and the anticipating benefits of its product candidates, including TP-03, the timing, objectives and results of the clinical trials and anticipated regulatory and development milestones, including the timing of the Saturn-2 clinical trial and submission of an NDA, 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 and Form 10-Q for the quarter ended March 31, 2021 filed with the SEC on May 11, 2021, which Tarsus incorporates by reference into this press release and 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]A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/d788bb0e-ef21-4338-aa1d-dc7612611b81