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WALTHAM, Mass., Nov. 14, 2019 (GLOBE NEWSWIRE) -- Chiasma, Inc. (NASDAQ: CHMA), a clinical-stage biopharmaceutical company focused on improving the lives of patients with rare and serious chronic diseases, today announced that William Ludlam, M.D., Ph.D., Senior Vice President of Clinical Development and Medical Affairs, will present at the 13th Acromegaly Consensus Conference, to be held from November 17th-19th in Fort Lauderdale, Florida. Dr. Ludlam is scheduled to present on Sunday, November 17th.
“We are pleased to be sharing positive top-line data from our Phase 3 CHIASMA OPTIMAL trial of MYCAPSSA®, that is being developed for the maintenance treatment of adult acromegaly patients, at the conference this year,” said Dr. William Ludlam. “We believe there is a high unmet need amongst acromegaly patients for treatment options that can address the challenges associated with injectable therapies. If marketing approval is granted for MYCAPSSA®, we believe it has the potential to fundamentally change the lives of many patients for the better as the first oral somatostatin analog treatment alternative in an injectables-only market.”
Chiasma remains on track to file its NDA by year-end and expects possible FDA approval in mid-2020, following an expected six-month PDUFA review classification. In parallel, the company is conducting a Phase 3 clinical trial, MPOWEREDTM, which is designed to support an application for marketing approval in the European Union, and the company remains on track to report top-line data in the second half of 2020.
The Acromegaly Consensus Conference is a closed, invitation-only workshop where key opinion leaders advise on evidence-based treatment guidelines for acromegaly patients.
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. We believe that approximately 8,000 adult acromegaly patients are chronically treated with somatostatin analogs in the United States.
Chiasma is focused on improving 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 July 2019, the Company reported positive top-line data from its CHIASMA OPTIMAL Phase 3 clinical trial for its octreotide capsules product candidate, conditionally trade named MYCAPSSA, for the maintenance therapy of adult patients with acromegaly in whom prior treatment with somatostatin analogs has been shown to be effective and tolerated. Prior to trial initiation, the Company reached agreement with the FDA on the design of the trial through a special protocol assessment. Chiasma is headquartered in Waltham, 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.
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 development of octreotide capsules, conditionally named MYCAPSSA, for the treatment of acromegaly, the data from the CHIASMA OPTIMAL trial and whether the data will support the submission of an NDA for octreotide capsules and ultimately regulatory approval, statements regarding the timing of NDA submission, regulatory review, including the company’s anticipated eligibility for a six-month PDUFA review cycle, and potential approval, statements concerning the nature of the FDA’s review of any such NDA submission and whether the data submission will be sufficient to support regulatory approval, the Company’s efforts to potentially obtain regulatory approval in the European Union by conducting the ongoing MPOWERED Phase 3 clinical trial, the timing of receipt and announcement of top-line and other clinical data and submission of regulatory filings, the Company’s ability to release top-line data from the MPOWERED trial during the second half of 2020, and statements concerning the therapeutic potential and the ability to become a standard of care of MYCAPSSA, if approved. Any forward-looking statements in this press release are based on management’s current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. For a discussion of these and other risks and uncertainties, and other important factors, any of which could cause our actual results to differ from those contained in the forward-looking statements, see the section entitled “Risk Factors” in Chiasma’s Annual Report on Form 10-K for the year ended December 31, 2018, 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.
Vice President, Investor Relations and Corporate Communications
Ashley R. Robinson
LifeSci Advisors, LLC