 -- The mean of the 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 n19 was maintained within normal limits at the end of the 48-week OLE period -- -- All MYCAPSSA responders IGF-1 within normal limits who enrolled into the OLE completed the 48-week period; 93 maintained their response at the end of this period --NEEDHAM, Mass., July 27, 2020 GLOBE NEWSWIRE -- Chiasma, Inc. NASDAQ: CHMA, a commercial stage biopharmaceutical company utilizing its delivery platform technology to develop oral therapies to reduce the burden of chronic injections for people with rare diseases, today announced 48-week, open-label efficacy and safety data from the Phase 3 CHIASMA OPTIMAL Octreotide capsules vs. Placebo Treatment In MultinationAL centers open-label extension OLE study of MYCAPSSA octreotide capsules.We are excited to see in the OLE data that MYCAPSSA, the only FDA-approved oral somatostatin analog, maintained insulin-like growth factor 1 IGF-1 levels within normal limits for an additional 48-weeks following the completion of the 36-week CHIASMA OPTIMAL Phase 3 clinical trial, said William Ludlam, M.D., Ph.D., senior vice president of clinical development and medical affairs at Chiasma. All MYCAPSSA responders that entered into the OLE study continued to take MYCAPSSA after an additional 48 weeks, providing further evidence of patient satisfaction and preference for this recently approved oral treatment option.The OLE study, which is still ongoing, is examining the longer-term safety and efficacy of MYCAPSSA in patients who participated in our Phase 3 CHIASMA OPTIMAL clinical trial. Key findings from the OLE at 48-weeks include: The mean of the IGF-1 levels for the population of all MYCAPSSA treated patients that completed the 36-week, double-blind placebo controlled DPC CHIASMA OPTIMAL trial and continued into the OLE n19 was maintained within normal limits at the end of the 48-week OLE period. 90 of patients enrolled into the OLE that were treated with MYCAPSSA during the DPC phase of the study n20 completed the 48-week OLE period. All patients that enrolled into the OLE as responders to MYCAPSSA IGF-1 within normal limits, n14 completed the 48-week OLE period and 93 maintained their response within the normal limits at the end of this period. The safety profile observed during OLE was generally consistent with the safety of MYCAPSSA noted in the 36-week CHIASMA OPTIMAL trial with no new patterns noted with the increased duration of exposure.Raj Kannan, chief executive officer of Chiasma, added, these longer term data reaffirm our belief in the potential for MYCAPSSA to be the new standard of pharmacological care for patients with acromegaly who face significant challenges with their octreotide and lanreotide injectables.In June 2020, the U.S. Food and Drug Administration FDA approved MYCAPSSA for long-term maintenance treatment in acromegaly patients who have responded to and tolerated treatment with octreotide or lanreotide. MYCAPSSA is the first and only oral somatostatin analog approved by the FDA and the first product approved by the FDA utilizing Chiasmas Transient Permeability Enhancer TPE technology.CHIASMA OPTIMAL Global Phase 3 Trial The CHIASMA OPTIMAL trial was a randomized, double-blind, placebo-controlled, nine-month Phase 3 clinical trial of octreotide capsules that was conducted under a special protocol assessment SPA agreement with the FDA. The trial enrolled 56 adult acromegaly patients whose disease was biochemically controlled by injectable somatostatin analogs octreotide or lanreotide based upon levels of IGF-1, a byproduct of increased growth hormone GH, levels caused by acromegaly average IGF-1 1.0 × upper limit of normal ULN. The patients also had confirmed active acromegaly following their last surgical intervention based upon an elevated IGF-1 at that time of 1.3 × ULN. Patients were randomized on a 1:1 basis, to octreotide capsules or placebo. Patients were dose titrated from 40 mg per day equaling one capsule in the morning and one capsule in the evening to up to a maximum of 80 mg per day equaling two capsules in the morning and two capsules in the evening. Patients who met the predefined withdrawal criteria, or discontinued from oral treatment for any reason, in either treatment arm during the course of the trial were considered treatment failures, reverted to their original treatment of injections and monitored for the remainder of the trial. The primary endpoint of the trial was the proportion of patients who maintained their biochemical response at the end of the nine-month, double-blind, placebo-controlled period as measured using the average of the last two IGF-1 levels 1.0 × ULN assessed at weeks 34 and 36. Hierarchical secondary endpoints include: proportion of patients who maintain GH response at week 36 compared to screening; time to loss of response: IGF-1 of 2 consecutive visits is 1.0 × ULN; time to loss of response: IGF-1 of 2 consecutive visits is 1.3 × ULN; and proportion of patients requiring reversion to prior treatment. As previously announced, CHIASMA OPTIMAL met the primary endpoint and all secondary endpoints.About MYCAPSSA INDICATION AND IMPORTANT SAFETY INFORMATIONINDICATION 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 INFORMATIONWARNINGS 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 The full Prescribing Information for MYCAPSSA is available at 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 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 is the first and only oral somatostatin analog approved by the FDA. 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 companys website at 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 open label extension of the CHIASMA OPTIMAL trial, and statements concerning the commercial or therapeutic potential of MYCAPSSA, including its ability to become a standard of care, and the anticipated market acceptance 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. 