GlobeNewswire Inc | Jun 28, 2021 04:12PM EDT

June 28, 2021

NEEDHAM, Mass., June 28, 2021 (GLOBE NEWSWIRE) -- Chiasma, Inc. (NASDAQ: CHMA), (Chiasma or the Company), 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, today announced that it has submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) seeking approval of MYCAPSSA (oral octreotide capsules) as a maintenance therapy for adults with acromegaly.

The MAA is supported by positive results from Chiasmas global Phase 3 MPOWERED non-inferiority clinical trial comparing MYCAPSSA to long-acting injectable somatostatin analogs (iSSAs) for maintenance of biochemical response in patients with acromegaly who previously responded toboth therapies. MYCAPSSA, the first and only oral somatostatin analog for the treatment of acromegaly approved by the Food and Drug Administration (FDA), is available in the U.S. for long-term maintenance treatment in acromegaly patients who have responded to and tolerated treatment with injectable octreotide or lanreotide.

"We are pleased to submit our marketing authorization application to the EMA as planned, as this marks an important step forward in our mission to expand the availability of MYCAPSSA to patients outside the U.S. suffering from acromegaly, said Raj Kannan, chief executive officer of Chiasma.

About the CHIASMA MPOWEREDTrialThe MPOWERED trial was a global, randomized, open-label and active-controlled, 15-month trial intended to support approval of MYCAPSSA(oral octreotide capsules) in theEuropean Union. This non-inferiority clinical trial was designed to compare MYCAPSSA to long-acting injectable somatostatin analogs (SSAs) for maintenance of biochemical response in patients with acromegaly. The trial enrolled 146 adult acromegaly patients of which 92 patients who were responders to MYCAPSSA after a six-month run-in phase were then randomized to a nine-month controlled (RCT) phase to either receive continued treatment on MYCAPSSA (n=55) or their prior injectable therapy (octreotide long-acting release or lanreotide autogel) (n=37). The primary endpoint of the trial was time-weighted average of IGF-1 <1.3 x upper limit of normal during the nine-month RCT phase. As previously announced, MPOWERED met its primary endpoint of non-inferiority compared to long-acting SSA injectables.

About MYCAPSSAINDICATION AND IMPORTANT SAFETY INFORMATION

INDICATION AND USAGEMYCAPSSA (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.

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

Blood sugar, thyroid levels, and vitamin B12levels 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 REACTIONSThe 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 INTERACTIONSThe 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.

PREGNANCYAdvise 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 orwww.fda.gov/medwatch.

The full Prescribing Information for MYCAPSSA is available atwww.MYCAPSSA.com.

About AcromegalyAcromegaly 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 inthe United States.

About ChiasmaChiasma 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. InJune 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 inNeedham, MAwith a wholly owned subsidiary inIsrael. MYCAPSSA, TPE and CHIASMA are registered trademarks of Chiasma. For more information, please visit the companys website atwww.chiasma.com.

Forward-Looking StatementsThis 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 companys development of MYCAPSSA for the treatment of acromegaly, statements regarding the regulatory review of MYCAPSSA, statements regarding the data from the MPOWERED trial and whether the data will support the submission of a Marketing Authorization Application (MAA) to theEuropean Medicines Agency(EMA) for MYCAPSSA in theEuropean Unionand ultimately regulatory approval, statements regarding the companys 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 commercial or therapeutic potential of MYCAPSSA. Such statements are subject to numerous important factors, risks and uncertainties, many of which are beyond the companys control, that may cause actual events or results to differ materially from the companys current expectations. Managements 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 companys clinical trials to obtain regulatory approval in theEuropean Unionor elsewhere, the impact the ongoing COVID-19 pandemic may have on the companys 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 companys actual results to differ from those contained in the forward-looking statements, see the section entitled Risk Factors in Chiasmas Quarterly Report on Form 10-Q for the quarter endedMarch 31, 2021, and in subsequent filings with theSecurities 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 RobinsonLifeSci Advisors, LLC617-430-7577arr@lifesciadvisors.com

Media Relations:Patrick BurseyLifeSci Communications646-876-4932pbursey@lifescicomms.com