CHMA Chiasma Inc.

4.16
+0.18  (+5%)
Previous Close 3.98
Open 4.05
52 Week Low 2.88
52 Week High 7.75
Market Cap $240,465,035
Shares 57,804,095
Float 51,828,246
Enterprise Value $71,569,175
Volume 1,961,232
Av. Daily Volume 1,065,760
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Drug Pipeline

Drug Stage Notes
Mycapssa - MPOWERED
Maintenance treatment of adult acromegaly
Phase 3
Phase 3
Phase 3 trial met primary non-inferiority endpoint - November 18, 2020.
Mycapssa - OPTIMAL
Acromegaly
Approved
Approved
FDA approval announced June 26, 2020.
Mycapssa
Acromegaly
CRL
CRL
CRL April 15 2016

Latest News

  1. NEEDHAM, Mass., Jan. 19, 2021 (GLOBE NEWSWIRE) -- Chiasma, Inc. (NASDAQ:CHMA), a commercial-stage biopharmaceutical company utilizing its delivery platform technology to develop and commercialize oral therapies to improve the lives of patients with rare diseases currently treated with burdensome and painful injections, as evidenced by its recent phased launch of MYCAPSSA® as the first oral therapy for the treatment of acromegaly, today announced the hiring of John Doyle as its new Chief Financial Officer, effective today. As previously reported, Mark Fitzpatrick, Chiasma's current President and Principal Financial Officer, will remain with the company in a consulting role through June 30, 2021 to help facilitate a transition of responsibilities…

    NEEDHAM, Mass., Jan. 19, 2021 (GLOBE NEWSWIRE) -- Chiasma, Inc. (NASDAQ:CHMA), a commercial-stage biopharmaceutical company utilizing its delivery platform technology to develop and commercialize oral therapies to improve the lives of patients with rare diseases currently treated with burdensome and painful injections, as evidenced by its recent phased launch of MYCAPSSA® as the first oral therapy for the treatment of acromegaly, today announced the hiring of John Doyle as its new Chief Financial Officer, effective today. As previously reported, Mark Fitzpatrick, Chiasma's current President and Principal Financial Officer, will remain with the company in a consulting role through June 30, 2021 to help facilitate a transition of responsibilities to Mr. Doyle. Prior to joining Chiasma, Mr. Doyle served as Vice President of Finance and Investor Relations at Verastem, Inc.

    "It is my pleasure to welcome John to Chiasma, and I believe he will make an immediate impact as we continue to execute on our U.S. commercial launch of MYCAPSSA," stated Raj Kannan, chief executive officer of Chiasma. "John brings an established track record of leadership and success, and I look forward to working with him in realizing the full potential of Chiasma."

    "I would also like to thank Mark Fitzpatrick for his dedicated service to Chiasma since joining the company in 2015. Mark has served in a variety of leadership roles, including as Chief Executive Officer, and his many significant contributions have enabled our potential future success. On behalf of the entire Chiasma team, I wish Mark the very best in his future endeavors," Mr. Kannan added.

    "I was attracted to Chiasma because of the company's unwavering commitment to bring MYCAPSSA to patients in the U.S. and globally, potentially improving the lives of patients suffering from acromegaly," stated Mr. Doyle. "As an early commercial-stage company, I cannot think of a more exciting time to join the Chiasma team, and I look forward to contributing to the company's commercial and financial goals."

    Mr. Doyle joins Chiasma from Verastem, Inc., a publicly traded biopharmaceutical company, where he most recently served as Vice President of Finance and Investor Relations. Prior to joining Verastem in February 2018, he served as Head of Financial Planning & Analysis at SimpliVity Corp., a software company that was acquired by Hewlett Packard Enterprises in February 2017. Before that, Mr. Doyle was Director of Business Unit Financial Planning & Analysis, Early Phase Division, at PAREXEL, a publicly traded pharmaceutical contract research organization. Earlier in his career, he served in increasingly senior financial planning and analysis roles at Hologic, Inc., a publicly traded provider of medical diagnostic, surgical and imaging products. Mr. Doyle holds a B.S. in finance from the University of Massachusetts.

    About MYCAPSSA

    INDICATION AND IMPORTANT SAFETY INFORMATION

    INDICATION AND USAGE

    MYCAPSSA (octreotide) delayed-release capsules, for oral use, is a somatostatin analog indicated for long-term maintenance treatment in acromegaly patients who have responded to and tolerated treatment with octreotide or lanreotide.

    CONTRAINDICATIONS

    Hypersensitivity to octreotide or any of the components of MYCAPSSA. Anaphylactoid reactions, including anaphylactic shock, have been reported in patients receiving octreotide.

    IMPORTANT SAFETY INFORMATION

    Warnings and Precautions

    MYCAPSSA can cause problems with the gallbladder. Monitor patients periodically. Discontinue if complications of cholelithiasis are suspected.

    Blood sugar, thyroid levels, and vitamin B12 levels should be monitored and treated accordingly.

    Bradycardia, arrhythmia, or conduction abnormalities may occur. Treatment with drugs that have bradycardia effects may need to be adjusted.

    ADVERSE REACTIONS

    The most common adverse reactions (incidence >10%) are nausea, diarrhea, headache, arthralgia, asthenia, hyperhidrosis, peripheral swelling, blood glucose increased, vomiting, abdominal discomfort, dyspepsia, sinusitis, and osteoarthritis.

    DRUG INTERACTIONS

    The following drugs require monitoring and possible dose adjustment when used with MYCAPSSA: cyclosporine, insulin, antidiabetic drugs, calcium channel blockers, beta blockers, lisinopril, digoxin, bromocriptine, and drugs mainly metabolized by CYP3A4. Counsel women to use an alternative non-hormonal method of contraception or a back-up method when MYCAPSSA is used with combined oral contraceptives.

    Patients taking proton pump inhibitors, H2-receptor antagonists, or antacids concomitantly with MYCAPSSA may require increased dosages of MYCAPSSA.

    PREGNANCY

    Advise premenopausal females of the potential for an unintended pregnancy.

    To report SUSPECTED ADVERSE REACTIONS, contact the product information department at 1-844-312-2462 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch

    The full Prescribing Information for MYCAPSSA is available at www.MYCAPSSA.com.

    About Acromegaly

    Acromegaly typically develops when a benign tumor of the pituitary gland produces too much growth hormone, ultimately leading to significant health problems. Common features of acromegaly are facial changes, intense headaches, joint pain, impaired vision and enlargement of the hands, feet, tongue and internal organs. Serious health conditions associated with the progression of acromegaly include type 2 diabetes, hypertension, respiratory disorders and cardiac and cerebrovascular disease. Chiasma estimates that approximately 8,000 adult acromegaly patients are chronically treated with somatostatin analog injections in the United States.

    About Chiasma

    Chiasma is a commercial-stage biopharmaceutical company focused on developing and commercializing oral therapies to improve the lives of patients who face challenges associated with their existing treatments for rare and serious chronic diseases. Employing its Transient Permeability Enhancer (TPE®) technology platform, Chiasma seeks to develop oral medications that are currently available only as injections. In June 2020, Chiasma received FDA approval of MYCAPSSA for long-term maintenance therapy in acromegaly patients who have responded to and tolerated treatment with octreotide or lanreotide. MYCAPSSA, the first and only oral somatostatin analog approved by the FDA, is available for commercial sale. Chiasma is headquartered in Needham, MA with a wholly owned subsidiary in Israel. MYCAPSSA, TPE and CHIASMA are registered trademarks of Chiasma. For more information, please visit the company's website at www.chiasma.com.

    Forward-Looking Statements

    This release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, including, but not limited to, statements regarding the potential commercial success of MYCAPSSA. Such statements are subject to numerous important factors, risks and uncertainties, many of which are beyond the company's control, that may cause actual events or results to differ materially from the company's current expectations. Management's expectations and, therefore, any forward-looking statements in this press release could be affected by risks and uncertainties. For a discussion of these risks and uncertainties, and other important factors, any of which could cause the company's actual results to differ from those contained in the forward-looking statements, see the section entitled "Risk Factors" in Chiasma's Quarterly Report on Form 10-Q for the quarter ended September 30, 2020, and in subsequent filings with the Securities and Exchange Commission. All information in this press release is as of the date of the release, and Chiasma undertakes no duty to update this information unless required by law.

    Contacts:

    Investor Relations and Corporate Communications:

    Ashley Robinson

    LifeSci Advisors, LLC

    617-430-7577

    Media Relations:

    Patrick Bursey

    LifeSci Communications

    646-876-4932



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  2. MYCAPSSA® launch in US continuing to gain traction with physicians, patients, and payers

    MYCAPSSA®EMA submission for EU marketing approval on track for mid-2021 following positive results of MPOWERED Phase 3 clinical trial

    NEEDHAM, Mass., Jan. 06, 2021 (GLOBE NEWSWIRE) -- Chiasma, Inc. (NASDAQ:CHMA), a commercial-stage biopharmaceutical company utilizing its delivery platform technology to develop and commercialize oral therapies to improve the lives of patients with rare diseases currently treated with burdensome and painful injections, as evidenced by its recent phased launch of MYCAPSSA® as the first oral therapy for the treatment of acromegaly, today reviewed its 2020 accomplishments and previewed its anticipated 2021 corporate milestones…

    MYCAPSSA® launch in US continuing to gain traction with physicians, patients, and payers

    MYCAPSSA® EMA submission for EU marketing approval on track for mid-2021 following positive results of MPOWERED Phase 3 clinical trial

    NEEDHAM, Mass., Jan. 06, 2021 (GLOBE NEWSWIRE) -- Chiasma, Inc. (NASDAQ:CHMA), a commercial-stage biopharmaceutical company utilizing its delivery platform technology to develop and commercialize oral therapies to improve the lives of patients with rare diseases currently treated with burdensome and painful injections, as evidenced by its recent phased launch of MYCAPSSA® as the first oral therapy for the treatment of acromegaly, today reviewed its 2020 accomplishments and previewed its anticipated 2021 corporate milestones.

    2020 Key Highlights:

    • MYCAPSSA Approved in the U.S. as the first and only oral somatostatin analog (SSA) for the long-term maintenance treatment of patients with acromegaly who responded to and tolerated treatment with octreotide or lanreotide.
      • Approval was based on the positive CHIASMA OPTIMAL Phase 3 trial results which were published in the Journal of Clinical Endocrinology & Metabolism and presented at the 2020 Endocrine Society Annual Meeting (ENDO) along with six other scientific posters relevant to MYCAPSSA.
    • Commercial Launch of MYCAPSSA in the U.S. Late in the third quarter of 2020, Chiasma commenced the initial phase of the MYCAPSSA U.S. commercial launch with a focused salesforce calling on approximately one-third of key prescribing accounts. Chiasma progressed to the second phase of the launch at the beginning of 2021 with an expanded salesforce hired during the fourth quarter of 2020. Progression to the final phase of the launch with a full-strength salesforce is expected after market conditions improve beyond the COVID era.



    • Early launch insights and progress:



      • Coverage of MYCAPSSA by multiple payers insuring approximately 150 million lives provides a solid foundation for MYCAPSSA uptake in 2021.
      • Positive and encouraging feedback on MYCAPSSA from endocrinologists and patients supports the company's goal of ultimately becoming the standard of pharmacological care in acromegaly.
      • Preliminary (unaudited) net revenues for 2020 are expected to be between $0.9 and $1.1 million.  
    • Reported Positive Data from CHIASMA OPTIMAL Open Label Extension. The efficacy and safety (tolerability) seen in the 1-year extension phase of the study (48 weeks) was similar to that seen in the 36-week core study period. The mean of the insulin-like growth factor 1 (IGF-1) levels for the population of all MYCAPSSA treated patients that completed the 36-week core CHIASMA OPTIMAL trial and continued into the open-label extension (OLE) (n=19) was maintained within normal limits at the end of the 48-week OLE period.



    • Reported Positive MPOWERED Phase 3 Topline Data. The MPOWERED study met its primary non-inferiority endpoint. 91% of patients on MYCAPSSA maintained IGF-1 response (95% CI = 80%, 97%) compared to 100% on injectable SSAs (95% CI = 91%, 100%). The positive clinical trial results provide Chiasma a pathway to pursue regulatory approval of MYCAPSSA in the European Union (EU), further strengthen the available robust clinical data set for MYCAPSSA and provide additional meaningful information for healthcare providers in treating patients with acromegaly.



    • Strengthened Balance Sheet for U.S. Commercial Launch. In April, Chiasma entered into a revenue interest financing agreement with HealthCare Royalty Partners (HCR) for up to $75 million. Also, in July, Chiasma raised approximately $75 million of net proceeds through an underwritten public offering of common stock and pre-funded warrants. Chiasma ended the year with approximately $135 million in cash, cash equivalents and marketable securities (exclusive of approximately $20 million of restricted cash), which is expected to fund its operations as currently planned through at least the end of 2021, including the execution of Chiasma's planned 2021 U.S. MYCAPSSA commercial launch strategy.

    "2020 was the beginning of an important transformation for Chiasma from a company with a strong research and development foundation to a commercial-stage company," stated Raj Kannan, chief executive officer. "We are pleased with the progress of the MYCAPSSA launch to date and the encouraging feedback we have received from physicians, patients and payers. In 2021, we continue to build upon the MYCAPSSA launch in the United States while pursuing MYCAPSSA approval in the European Union. The recently reported positive MPOWERED clinical trial results further support our goal to make MYCAPSSA the new standard of pharmacological care in the long-term maintenance treatment of people with acromegaly."

    Anticipated 2021 Milestones and Related Guidance:

    • Grow MYCAPSSA revenues in the U.S. by building on the progress made with the initial, focused selling effort in the first four months since launch:   Chiasma plans to drive adoption for MYCAPSSA with a broader group of physicians by expanding from a 36-person customer-facing team today to an approximately 45-person customer-facing team as market challenges associated with COVID-19 recede and payer coverage continues to expand.



    • MYCAPSSA EMA Submission. In mid-2021, Chiasma plans to submit a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) seeking regulatory approval to market MYCAPSSA to patients with acromegaly in the EU.



    • CHIASMA OPTIMAL Open Label Extension Data Oral Presentation at Virtual ENDO 2021. Chiasma plans to present data on longer-term efficacy and safety of MYCAPSSA from the CHIASMA OPTIMAL trial's open-label extension at the virtual 2021 Endocrine Society Annual Meeting (ENDO), which is being held March 20-23.



    • Presentation of MPOWERED Phase 3 Data at Medical Conferences and Publication in a Peer Reviewed Medical Journal. Chiasma expects to present MPOWERED Phase 3 data analyses at upcoming endocrinology scientific meetings in spring and in fall 2021 and submit the results of the MPOWERED trial to a peer-reviewed journal for expected publication in 2021.



    • 2021 Financial Guidance. Operating expense for the full year 2021 is expected to be in a range of $80 million to $90 million, including estimated stock-based compensation expense in a range of $5 million to $6 million. This guidance is based on the company's current U.S. commercial plans and excludes expenditure for potential EU launch preparations of MYCAPSSA and potential additional new product development programs.  

    2021 LifeSci Advisors Corporate Access Event

    Chiasma management will be available to meet with institutional investors and analysts virtually at the 2021 LifeSci Advisors Corporate Access Event on January 7-8 and 11-14.

    About MYCAPSSA

    INDICATION AND IMPORTANT SAFETY INFORMATION

    INDICATION AND USAGE

    MYCAPSSA (octreotide) delayed-release capsules, for oral use, is a somatostatin analog indicated for long-term maintenance treatment in acromegaly patients who have responded to and tolerated treatment with octreotide or lanreotide.

    CONTRAINDICATIONS

    Hypersensitivity to octreotide or any of the components of MYCAPSSA. Anaphylactoid reactions, including anaphylactic shock, have been reported in patients receiving octreotide.

    IMPORTANT SAFETY INFORMATION

    Warnings and Precautions

    MYCAPSSA can cause problems with the gallbladder. Monitor patients periodically. Discontinue if complications of cholelithiasis are suspected.

    Blood sugar, thyroid levels, and vitamin B12 levels should be monitored and treated accordingly.

    Bradycardia, arrhythmia, or conduction abnormalities may occur. Treatment with drugs that have bradycardia effects may need to be adjusted.

    ADVERSE REACTIONS

    The most common adverse reactions (incidence >10%) are nausea, diarrhea, headache, arthralgia, asthenia, hyperhidrosis, peripheral swelling, blood glucose increased, vomiting, abdominal discomfort, dyspepsia, sinusitis, and osteoarthritis.

    DRUG INTERACTIONS

    The following drugs require monitoring and possible dose adjustment when used with MYCAPSSA: cyclosporine, insulin, antidiabetic drugs, calcium channel blockers, beta blockers, lisinopril, digoxin, bromocriptine, and drugs mainly metabolized by CYP3A4. Counsel women to use an alternative non-hormonal method of contraception or a back-up method when MYCAPSSA is used with combined oral contraceptives.

    Patients taking proton pump inhibitors, H2-receptor antagonists, or antacids concomitantly with MYCAPSSA may require increased dosages of MYCAPSSA.

    PREGNANCY

    Advise premenopausal females of the potential for an unintended pregnancy.

    To report SUSPECTED ADVERSE REACTIONS, contact the product information department at 1-844-312-2462 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch

    The full Prescribing Information for MYCAPSSA is available at www.MYCAPSSA.com.

    About Acromegaly

    Acromegaly typically develops when a benign tumor of the pituitary gland produces too much growth hormone, ultimately leading to significant health problems. Common features of acromegaly are facial changes, intense headaches, joint pain, impaired vision and enlargement of the hands, feet, tongue and internal organs. Serious health conditions associated with the progression of acromegaly include type 2 diabetes, hypertension, respiratory disorders and cardiac and cerebrovascular disease. Chiasma estimates that approximately 8,000 adult acromegaly patients are chronically treated with somatostatin analog injections in the United States.

    About Chiasma

    Chiasma is a commercial-stage biopharmaceutical company focused on developing and commercializing oral therapies to improve the lives of patients who face challenges associated with their existing treatments for rare and serious chronic diseases. Employing its Transient Permeability Enhancer (TPE®) technology platform, Chiasma seeks to develop oral medications that are currently available only as injections. In June 2020, Chiasma received FDA approval of MYCAPSSA for long-term maintenance therapy in acromegaly patients who have responded to and tolerated treatment with octreotide or lanreotide. MYCAPSSA, the first and only oral somatostatin analog approved by the FDA, is available for commercial sale. Chiasma is headquartered in Needham, MA with a wholly owned subsidiary in Israel. MYCAPSSA, TPE and CHIASMA are registered trademarks of Chiasma. For more information, please visit the company's website at www.chiasma.com.

    Forward-Looking Statements

    This release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, including, but not limited to, statements regarding  the company's expectations relating to MYCAPSSA for the long-term maintenance therapy in acromegaly patients who have responded to and tolerated treatment with octreotide or lanreotide, the commercialization of MYCAPSSA, including efficiency improvements in processes for prescriptions and delivery of commercial product, the commercial or therapeutic potential of MYCAPSSA, including its ability to become a standard of care and the anticipated market acceptance and third-party reimbursement of and access to MYCAPSSA, the expansion of the customer-facing team, the data from the MPOWERED trial and whether the data will support the submission of a marketing authorization application (MAA) to the European Medicines Agency (EMA) for MYCAPSSA in the European Union and ultimately regulatory approval, the presentation and publication plans for the data from the MPOWERED trial, and the company's financial guidance, including operating expense and cash runway guidance. Such statements are subject to numerous important factors, risks and uncertainties, many of which are beyond the company's control, that may cause actual events or results to differ materially from the company's current expectations. Management's expectations and, therefore, any forward-looking statements in this press release could be affected by risks and uncertainties relating to a number of factors, including the following: the content and timing of decisions made by the FDA or EMA, the sufficiency of the data collected from the company's clinical trials to obtain regulatory approval in the European Union or elsewhere, the company's ability to retain requisite regulatory approvals for the commercial sale of MYCAPSSA in the United States, the timing and costs involved in establishing and maintaining a commercial organization and launching the sale of MYCAPSSA, and the impact the ongoing COVID-19 pandemic may have on the company's business, including its expected development, manufacturing, regulatory and commercialization timelines for MYCAPSSA. For a discussion of these and other risks and uncertainties, and other important factors, any of which could cause the company's actual results to differ from those contained in the forward-looking statements, see the section entitled "Risk Factors" in Chiasma's Quarterly Report on Form 10-Q for the quarter ended September 30, 2020, and in subsequent filings with the Securities and Exchange Commission. All information in this press release is as of the date of the release, and Chiasma undertakes no duty to update this information unless required by law.

    Contacts:

    Investor Relations and Corporate Communications:

    Ashley Robinson

    LifeSci Advisors, LLC

    617-430-7577

    Media Relations:

    Patrick Bursey

    LifeSci Communications

    646-876-4932

     



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  3. NEEDHAM, Mass., Nov. 23, 2020 (GLOBE NEWSWIRE) -- Chiasma, Inc. (NASDAQ:CHMA), a commercial-stage biopharmaceutical company utilizing its delivery platform technology to develop and commercialize oral therapies to improve the lives of patients with rare diseases on burdensome and painful injections, today announced that management will be presenting and participating in investor meetings at both the Piper Sandler Healthcare Conference as well as the Evercore ISI HealthCONx Conference. Details for each conference are as follows:

    Piper Sandler Healthcare Conference:
    Date:Monday, November 23, 2020 *
    Time:10:00am ET
    Format:
    Fireside Chat

    * All presentations for the Piper Sandler Healthcare Conference will be available on Piper Sandler's conference

    NEEDHAM, Mass., Nov. 23, 2020 (GLOBE NEWSWIRE) -- Chiasma, Inc. (NASDAQ:CHMA), a commercial-stage biopharmaceutical company utilizing its delivery platform technology to develop and commercialize oral therapies to improve the lives of patients with rare diseases on burdensome and painful injections, today announced that management will be presenting and participating in investor meetings at both the Piper Sandler Healthcare Conference as well as the Evercore ISI HealthCONx Conference. Details for each conference are as follows:

    Piper Sandler Healthcare Conference:
    Date:Monday, November 23, 2020 *
    Time:10:00am ET
    Format:

    Fireside Chat

    * All presentations for the Piper Sandler Healthcare Conference will be available on Piper Sandler's conference portal at 10:00 am on Monday, November 23. Actual dates for the conference are November 30 – December 3.

    Evercore ISI HealthCONx Conference:
    Date:Thursday, December 3, 2020
    Time:1:00pm ET
    Format:Panel Discussion, "Easy Pills to Swallow: Oral Drugs for Large Endo Markets" - Chiasma, Crinetics and Lumos

    A live audio webcast of each of the two events may be accessed under "Events & Presentations" on the News and Investors section of Chiasma's website at https://ir.chiasma.com/events-presentations. A replay will be available for 90 days.

    About Chiasma

    Chiasma is a commercial-stage biopharmaceutical company focused on developing and commercializing oral therapies to improve the lives of patients who face challenges associated with their existing treatments for rare and serious chronic diseases. Employing its Transient Permeability Enhancer (TPE®) technology platform, Chiasma seeks to develop oral medications that are currently available only as injections. On June 26, 2020, Chiasma received FDA approval of MYCAPSSA for long-term maintenance therapy in acromegaly patients who have responded to and tolerated treatment with octreotide or lanreotide. MYCAPSSA, the first and only oral somatostatin analog approved by the FDA, is available for commercial sale in the United States. Chiasma is headquartered in Needham, MA with a wholly owned subsidiary in Israel. MYCAPSSA, TPE and CHIASMA are registered trademarks of Chiasma. For more information, please visit the company's website at www.chiasma.com.

    Investor Relations and Corporate Communications:

    Ashley Robinson

    LifeSci Advisors, LLC

    617-430-7577

    Media Relations:

    Patrick Bursey

    LifeSci Communications

    646-876-4932



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  4. NEEDHAM, Mass., Nov. 20, 2020 (GLOBE NEWSWIRE) -- Chiasma, Inc. (NASDAQ:CHMA), a commercial-stage biopharmaceutical company utilizing its delivery platform technology to develop and commercialize oral therapies to improve the lives of patients with rare diseases on burdensome and painful injections, today announced that it will host an expert panel on acromegaly and the results from its recently completed MPOWERED® Phase 3 clinical trial on Monday, November 30, 2020 at 11:00 am Eastern Time.

    The call will feature presentations by Key Opinion Leader (KOL) Maria Fleseriu, MD, FACE, lead investigator of the MPOWERED study, who will discuss the topline data from Chiasma's Phase 3 MPOWERED study as well as the unmet medical need in acromegaly…

    NEEDHAM, Mass., Nov. 20, 2020 (GLOBE NEWSWIRE) -- Chiasma, Inc. (NASDAQ:CHMA), a commercial-stage biopharmaceutical company utilizing its delivery platform technology to develop and commercialize oral therapies to improve the lives of patients with rare diseases on burdensome and painful injections, today announced that it will host an expert panel on acromegaly and the results from its recently completed MPOWERED® Phase 3 clinical trial on Monday, November 30, 2020 at 11:00 am Eastern Time.

    The call will feature presentations by Key Opinion Leader (KOL) Maria Fleseriu, MD, FACE, lead investigator of the MPOWERED study, who will discuss the topline data from Chiasma's Phase 3 MPOWERED study as well as the unmet medical need in acromegaly and the treatment burden that patients experience with monthly somatostatin analog injections. Additionally, a renowned patient advocate and Acromegaly Community President Jill Sisco will discuss the patient experience switching to MYCAPSSA®. Dr. Fleseriu and Ms. Sisco will be available to answer questions following the formal presentations.

    Chiasma's management team will also provide an overview of the MPOWERED Phase 3 topline data, which were announced on November 18th. MPOWERED (Maintenance of acromegaly Patients with Octreotide capsules compared with injections – Evaluation of REsponse Durability), was a global, randomized, non-inferiority, open-label, and active-controlled 15-month trial that was designed to support a potential marketing application of MYCAPSSA® in the European Union.

    This event is intended for institutional investors, sell-side analysts, and business development professionals only.  To register for the call, please click here.

    Maria Fleseriu, MD, FACE is a Professor of Medicine and Neurological Surgery and Director of the Pituitary Center at Oregon Health and Science University in Portland, Oregon and Immediate Past President of the Pituitary Society. Dr. Fleseriu has a long-standing clinical and research interest in the pathophysiology and treatment of pituitary and adrenal disorders. She is a frequent plenary guest speaker at national and international meetings on treatment of Cushing's, acromegaly and growth hormone deficiency, is global principal investigator in clinical trials, and has authored over 170 manuscripts in prestigious journals, including guidelines, consensus papers and book chapters.

    Dr. Fleseriu has been awarded the title of "Doctor Honors Causa" by the University of Medicine and Pharmacy "Carol Davila" Bucharest, she serves on the Board of Directors and chairs Physician Education Committee for Pituitary Society, she serves on several committees for the Endocrine Society, Pituitary Society, and American Association of Clinical Endocrinology and she is past chair of the Endocrine Society Guidelines Committee and the Hypopituitarism task force.

    Dr. Fleseriu is Chief Editor of Pituitary Endocrinology for Frontiers in Endocrinology, Section Head for Pituitary and Neuroendocrine F 1000, Associate Editor for European Journal of Endocrinology, Reviews in Endocrinology and Metabolism, Senior Editor for Endocrinology, Diabetes and Metabolism CR and a member of the editorial board of Pituitary. She has been involved in leadership positions of educational programs sponsored by the Endocrine Society, the Pituitary Society, and patient advocacy groups to teach physicians and patients about pituitary tumors and neuroendocrine disorders. She has served on multiple scientific advisory boards for biotechnology and pharmaceutical companies and participated in study design and has been global principal investigator for several Cushing's and acromegaly studies.

    Dr. Fleseriu received her medical degree from the University of Medicine and Pharmacy, Timisoara, Romania and completed endocrinology training at University Hospital Sibiu, National Institute of Endocrinology "C.I Parhon" (with focus on pituitary disorders), Romania and Centre Hospitalier Luxembourg in Luxembourg. She pursued additional residency in internal medicine at Case Western Reserve University and an endocrinology fellowship at Cleveland Clinic in USA.

    Jill Sisco is President of Acromegaly Community, Inc., a patient organization that helps educate patients and loved ones regarding this rare disease and provides guidance on how to cope with their difficult illness. Since her diagnosis in 2005, Jill has been an influential advocate towards a better quality of life for Acromegaly patients worldwide. In 2008, Jill became a leader in patient advocacy and has sat on several Acromegaly advisory boards. Jill has presented the patient perspective to FDA, co-authored several medical journal articles and abstracts regarding Acromegaly, and manages the widely visited patient community website and social media support groups. By organizing and hosting the biennial International Acromegaly Community Conference which engages patients, specialists, and pharmaceutical companies, Jill shows how passionate she is about providing an emotional and communal support network for people touched by acromegaly. She works tirelessly to enable forward thinking that will facilitate research, assist patients with their treatment plans, and provide positive outcomes for the future of acromegaly patients everywhere. Jill is highly respected in her community and has been a pioneer in building awareness around Acromegaly. Through her dedication, Jill leads by example and is a proponent of patients taking control of their lives and their disease and advocating for their best health possible.

    MPOWERED™ Phase 3 Clinical Trial

    The MPOWERED trial was a global, non-inferiority, randomized, open-label and active-controlled, 15-month trial intended to support approval of MYCPASSA in the European Union. Chiasma completed enrollment of 146 adult acromegaly patients into the trial in June 2019, of which 92 patients were deemed responders to octreotide capsules per the protocol following a six-month run-in were randomized to either octreotide capsules (n=55) or injectable somatostatin receptor ligands (octreotide LAR or lanreotide autogel) (n=37), and then followed for an additional nine months. The trial was designed to evaluate the proportion of patients who maintain their biochemical response to octreotide capsules and patient-reported outcomes in patients treated with octreotide capsules, compared to patients treated with leading injectable somatostatin analogs.

    About MYCAPSSA

    INDICATION AND IMPORTANT SAFETY INFORMATION

    INDICATION AND USAGE

    MYCAPSSA (octreotide) delayed-release capsules, for oral use, is a somatostatin analog indicated for long-term maintenance treatment in acromegaly patients who have responded to and tolerated treatment with octreotide or lanreotide.

    CONTRAINDICATIONS

    Hypersensitivity to octreotide or any of the components of MYCAPSSA. Anaphylactoid reactions, including anaphylactic shock, have been reported in patients receiving octreotide.

    IMPORTANT SAFETY INFORMATION

    Warnings and Precautions

    MYCAPSSA can cause problems with the gallbladder. Monitor patients periodically. Discontinue if complications of cholelithiasis are suspected.

    Blood sugar, thyroid levels, and vitamin B12 levels should be monitored and treated accordingly.

    Bradycardia, arrhythmia, or conduction abnormalities may occur. Treatment with drugs that have bradycardia effects may need to be adjusted.

    ADVERSE REACTIONS

    The most common adverse reactions (incidence >10%) are nausea, diarrhea, headache, arthralgia, asthenia, hyperhidrosis, peripheral swelling, blood glucose increased, vomiting, abdominal discomfort, dyspepsia, sinusitis, and osteoarthritis.

    DRUG INTERACTIONS

    The following drugs require monitoring and possible dose adjustment when used with MYCAPSSA: cyclosporine, insulin, antidiabetic drugs, calcium channel blockers, beta blockers, lisinopril, digoxin, bromocriptine, and drugs mainly metabolized by CYP3A4. Counsel women to use an alternative non-hormonal method of contraception or a back-up method when MYCAPSSA is used with combined oral contraceptives.

    Patients taking proton pump inhibitors, H2-receptor antagonists, or antacids concomitantly with MYCAPSSA may require increased dosages of MYCAPSSA.

    PREGNANCY

    Advise premenopausal females of the potential for an unintended pregnancy.

    To report SUSPECTED ADVERSE REACTIONS, contact the product information department at 1-844-312-2462 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch

    The full Prescribing Information for MYCAPSSA is available at www.MYCAPSSA.com.

    About Acromegaly

    Acromegaly typically develops when a benign tumor of the pituitary gland produces too much growth hormone, ultimately leading to significant health problems. Common features of acromegaly are facial changes, intense headaches, joint pain, impaired vision and enlargement of the hands, feet, tongue and internal organs. Serious health conditions associated with the progression of acromegaly include type 2 diabetes, hypertension, respiratory disorders and cardiac and cerebrovascular disease. Chiasma estimates that approximately 8,000 adult acromegaly patients are chronically treated with somatostatin analog injections in the United States.

    About Chiasma

    Chiasma is a commercial-stage biopharmaceutical company focused on developing and commercializing oral therapies to improve the lives of patients who face challenges associated with their existing treatments for rare and serious chronic diseases. Employing its Transient Permeability Enhancer (TPE®) technology platform, Chiasma seeks to develop oral medications that are currently available only as injections. On June 26, 2020, Chiasma received FDA approval of MYCAPSSA for long-term maintenance therapy in acromegaly patients who have responded to and tolerated treatment with octreotide or lanreotide. MYCAPSSA, the first and only oral somatostatin analog approved by the FDA, is available for commercial sale. Chiasma is headquartered in Needham, MA with a wholly owned subsidiary in Israel. MYCAPSSA, TPE and CHIASMA are registered trademarks of Chiasma. For more information, please visit the company's website at www.chiasma.com.

    Forward-Looking Statements

    This release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, including, but not limited to, statements regarding the data from the MPOWERED trial and whether the data will support the submission of a marketing authorization application (MAA) to the European Medicines Agency (EMA) for MYCAPSSA in the European Union and ultimately regulatory approval. Such statements are subject to numerous important factors, risks and uncertainties, many of which are beyond the company's control, that may cause actual events or results to differ materially from the company's current expectations. Management's expectations and, therefore, any forward-looking statements in this press release could be affected by risks and uncertainties relating to a number of factors, including the following: the content and timing of decisions made by the EMA, the sufficiency of the data collected from the company's clinical trials to obtain regulatory approval in the European Union or elsewhere, and the impact the ongoing COVID-19 pandemic may have on the company's business, including its expected development, manufacturing, regulatory and commercialization timelines for MYCAPSSA. For a discussion of these and other risks and uncertainties, and other important factors, any of which could cause the company's actual results to differ from those contained in the forward-looking statements, see the section entitled "Risk Factors" in Chiasma's Quarterly Report on Form 10-Q for the quarter ended September 30, 2020, and in subsequent filings with the Securities and Exchange Commission. All information in this press release is as of the date of the release, and Chiasma undertakes no duty to update this information unless required by law.

    Investor Relations and Corporate Communications:

    Ashley Robinson

    LifeSci Advisors, LLC

    617-430-7577

    Media Relations:

    Patrick Bursey

    LifeSci Communications

    646-876-4932



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  5. 91% of patients on MYCAPSSA maintained IGF-1 response in the 9-month randomized, controlled phase of the non-inferiority trial

    Company intends to submit a marketing application for MYCAPSSA in the EU in mid-2021

    Company to host conference call today at 8:00 a.m. ET

    NEEDHAM, Mass., Nov. 18, 2020 (GLOBE NEWSWIRE) -- Chiasma, Inc. (NASDAQ:CHMA), a commercial-stage biopharmaceutical company utilizing its delivery platform technology to develop and commercialize oral therapies to improve the lives of patients with rare diseases on burdensome and painful injections, today announced positive top-line data from its global Phase 3 MPOWERED™ non-inferiority clinical trial comparing MYCAPSSA® (oral octreotide capsules) to long-acting injectable somatostatin…

    91% of patients on MYCAPSSA maintained IGF-1 response in the 9-month randomized, controlled phase of the non-inferiority trial

    Company intends to submit a marketing application for MYCAPSSA in the EU in mid-2021

    Company to host conference call today at 8:00 a.m. ET

    NEEDHAM, Mass., Nov. 18, 2020 (GLOBE NEWSWIRE) -- Chiasma, Inc. (NASDAQ:CHMA), a commercial-stage biopharmaceutical company utilizing its delivery platform technology to develop and commercialize oral therapies to improve the lives of patients with rare diseases on burdensome and painful injections, today announced positive top-line data from its global Phase 3 MPOWERED™ non-inferiority clinical trial comparing MYCAPSSA® (oral octreotide capsules) to long-acting injectable somatostatin analogs (SSAs) for maintenance of biochemical response in patients with acromegaly. The MPOWERED trial was designed to support a planned marketing authorization application for MYCAPSSA in the European Union. MYCAPSSA is currently approved in the United States for long-term maintenance treatment in acromegaly patients who have responded to and tolerated treatment with injectable octreotide or lanreotide.

    The MPOWERED non-inferiority trial was designed to compare long-term maintenance treatment with MYCAPSSA, the first and only approved oral SSA therapy for acromegaly, to the long-acting injectables octreotide long-acting release and lanreotide autogel, in patients previously responding to these therapies. After a six-month run-in phase, 92 patients who were responders to MYCAPSSA were randomized to a nine-month controlled phase with continued treatment on MYCAPSSA or on their prior injectable therapy.

    Key Results:

    • The study met its primary non-inferiority endpoint. 91% of patients on MYCAPSSA maintained insulin-like growth factor 1 (IGF-1) response (95% CI = 80%, 97%) compared to 100% on injectable SSAs (95% CI = 91%, 100%). Response was defined as the time-weighted average of IGF-1 <1.3 x upper limit of normal (ULN) during the 9-month randomized, controlled treatment (RCT) phase.
    • MYCAPSSA maintained mean IGF-1 within normal limits and was comparable to injectable therapy: mean IGF-1 in the MYCAPSSA cohort at the beginning and end of the RCT phase was 0.9 × ULN and 0.9 × ULN, respectively, compared to 0.8 × ULN and 0.8 × ULN, respectively, in the injectable SSA cohort.

    "We are excited with the positive results from the MPOWERED study that demonstrated non-inferiority relative to long-acting SSAs. These results further strengthen the available robust clinical data set for MYCAPSSA and provide additional meaningful information for healthcare providers in treating patients with acromegaly," said Raj Kannan, chief executive officer of Chiasma. "In light of these positive results, we plan to submit a marketing authorization application for MYCAPSSA to the European Medicines Agency in mid-2021. While we are excited to report the preliminary top line results, further analyses of the trial results are ongoing, and we plan to present the full data set from the study at upcoming medical conferences in 2021."

    "I am pleased that the MPOWERED study met its primary endpoint of non-inferiority compared to long acting SSA injectables. These results should provide treating physicians with confidence that patients on injectables who are switched to oral octreotide can be expected to achieve comparable efficacy and safety," commented Maria Fleseriu, MD, FACE, lead investigator of the MPOWERED study, Professor of Medicine and Neurological Surgery, Director of the Pituitary Center at Oregon Health and Science University in Portland, Oregon, Immediate Past President of the Pituitary Society. "Many patients with acromegaly experience significant burdens with SSA injections, including injection site pain and reactions, and I believe that the results of the MPOWERED study underscore the importance of an oral treatment alternative for patients with acromegaly."

    MPOWERED MYCAPSSA® Safety:

    The safety profile of MYCAPSSA capsules in the MPOWERED trial was consistent with the known safety profile of octreotide but without adverse injection site reactions. No new or unexpected safety signals were detected during the study among MYCAPSSA subjects. See Important Safety Information below for contraindications, warnings, precautions and adverse reactions associated with MYCAPSSA based in the current approved labeling in the United States.

    Conference Call and Webcast Information

    Chiasma management will host a conference call and webcast to discuss the results of the MPOWERED study today, November 18, 2020, at 8:00 a.m. ET. The dial-in number in the U.S. / Canada is 877-407-4018; for international participants, the dial-in number is 201-689-8471. For all callers, please refer to Conference ID 13713200. To access the live webcast, please use the following link: http://public.viavid.com/index.php?id=142448

    A live audio webcast of the call may also be accessed under "Events & Presentations" on the News & Investors section of the Company's website, https://ir.chiasma.com/events-presentations. An archived replay of webcast will be available on the Company's website approximately two hours after the event. The archived webcast will be available for one year.

    MPOWERED™ Phase 3 Trial Design

    The MPOWERED trial was a global, randomized, open-label and active-controlled, 15-month trial intended to support approval of MYCPASSA in the European Union. Chiasma completed enrollment of 146 adult acromegaly patients into the trial in June 2019, of which 92 patients who were deemed responders to octreotide capsules per the protocol following a six-month run-in were randomized to either octreotide capsules (n=55) or injectable somatostatin receptor ligands (octreotide long-acting release or lanreotide autogel) (n=37), and then followed for an additional nine months. The trial was designed to evaluate the proportion of patients who maintain their biochemical response to octreotide capsules and patient-reported outcomes in patients treated with octreotide capsules, compared to patients treated with leading injectable somatostatin analogs.

    About MYCAPSSA

    INDICATION AND IMPORTANT SAFETY INFORMATION

    INDICATION AND USAGE

    MYCAPSSA (octreotide) delayed-release capsules, for oral use, is a somatostatin analog indicated for long-term maintenance treatment in acromegaly patients who have responded to and tolerated treatment with octreotide or lanreotide.

    CONTRAINDICATIONS

    Hypersensitivity to octreotide or any of the components of MYCAPSSA. Anaphylactoid reactions, including anaphylactic shock, have been reported in patients receiving octreotide.

    IMPORTANT SAFETY INFORMATION

    Warnings and Precautions

    MYCAPSSA can cause problems with the gallbladder. Monitor patients periodically. Discontinue if complications of cholelithiasis are suspected.

    Blood sugar, thyroid levels, and vitamin B12 levels should be monitored and treated accordingly.

    Bradycardia, arrhythmia, or conduction abnormalities may occur. Treatment with drugs that have bradycardia effects may need to be adjusted.

    ADVERSE REACTIONS

    The most common adverse reactions (incidence >10%) are nausea, diarrhea, headache, arthralgia, asthenia, hyperhidrosis, peripheral swelling, blood glucose increased, vomiting, abdominal discomfort, dyspepsia, sinusitis, and osteoarthritis.

    DRUG INTERACTIONS

    The following drugs require monitoring and possible dose adjustment when used with MYCAPSSA: cyclosporine, insulin, antidiabetic drugs, calcium channel blockers, beta blockers, lisinopril, digoxin, bromocriptine, and drugs mainly metabolized by CYP3A4. Counsel women to use an alternative non-hormonal method of contraception or a back-up method when MYCAPSSA is used with combined oral contraceptives.

    Patients taking proton pump inhibitors, H2-receptor antagonists, or antacids concomitantly with MYCAPSSA may require increased dosages of MYCAPSSA.

    PREGNANCY

    Advise premenopausal females of the potential for an unintended pregnancy.

    To report SUSPECTED ADVERSE REACTIONS, contact the product information department at 1-844-312-2462 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch

    The full Prescribing Information for MYCAPSSA is available at www.MYCAPSSA.com.

    About Acromegaly

    Acromegaly typically develops when a benign tumor of the pituitary gland produces too much growth hormone, ultimately leading to significant health problems. Common features of acromegaly are facial changes, intense headaches, joint pain, impaired vision and enlargement of the hands, feet, tongue and internal organs. Serious health conditions associated with the progression of acromegaly include type 2 diabetes, hypertension, respiratory disorders and cardiac and cerebrovascular disease. Chiasma estimates that approximately 8,000 adult acromegaly patients are chronically treated with somatostatin analog injections in the United States.

    About Chiasma

    Chiasma is a commercial-stage biopharmaceutical company focused on developing and commercializing oral therapies to improve the lives of patients who face challenges associated with their existing treatments for rare and serious chronic diseases. Employing its Transient Permeability Enhancer (TPE®) technology platform, Chiasma seeks to develop oral medications that are currently available only as injections. On June 26, 2020, Chiasma received FDA approval of MYCAPSSA for long-term maintenance therapy in acromegaly patients who have responded to and tolerated treatment with octreotide or lanreotide. MYCAPSSA, the first and only oral somatostatin analog approved by the FDA, is available for commercial sale in the United States. Chiasma is headquartered in Needham, MA with a wholly owned subsidiary in Israel. MYCAPSSA, TPE and CHIASMA are registered trademarks of Chiasma. For more information, please visit the company's website at www.chiasma.com.

    Forward-Looking Statements

    This release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, including, but not limited to, statements regarding the data from the MPOWERED trial and whether the data will support the submission of a marketing authorization application (MAA) to the European Medicines Agency (EMA) for MYCAPSSA in the European Union and ultimately regulatory approval, statements regarding the timing of an MAA submission and regulatory review, statements regarding the company's plans for the presentation of the full trial results, statements regarding the company's expectations relating to MYCAPSSA for the long-term maintenance therapy in acromegaly patients who have responded to and tolerated treatment with octreotide or lanreotide, and statements concerning the therapeutic potential of MYCAPSSA, including its ability to become a standard of care. Such statements are subject to numerous important factors, risks and uncertainties, many of which are beyond the company's control, that may cause actual events or results to differ materially from the company's current expectations. Management's expectations and, therefore, any forward-looking statements in this press release could be affected by risks and uncertainties relating to a number of factors, including the following: the content and timing of decisions made by the EMA, the sufficiency of the data collected from the company's clinical trials to obtain regulatory approval in the European Union or elsewhere, and the impact the ongoing COVID-19 pandemic may have on the company's business, including its expected development, manufacturing, regulatory and commercialization timelines for MYCAPSSA. For a discussion of these and other risks and uncertainties, and other important factors, any of which could cause the company's actual results to differ from those contained in the forward-looking statements, see the section entitled "Risk Factors" in Chiasma's Quarterly Report on Form 10-Q for the quarter ended September 30, 2020, and in subsequent filings with the Securities and Exchange Commission. All information in this press release is as of the date of the release, and the company undertakes no duty to update this information unless required by law.

    Investor Relations and Corporate Communications:

    Ashley Robinson

    LifeSci Advisors, LLC

    617-430-7577

    Media Relations:

    Patrick Bursey

    LifeSci Communications

    646-876-4932



    Primary Logo

    View Full Article Hide Full Article
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