Chiasma Announces 48-Week Safety and Efficacy Data from the Open-Label Extension Study of its CHIASMA OPTIMAL Phase 3 Trial Evaluating MYCAPSSA® in Patients with Acromegaly
-- 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) (n=19) 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:
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 Chiasma’s Transient Permeability Enhancer (TPE®) technology.
CHIASMA OPTIMAL Global Phase 3 Trial
INDICATION AND USAGE
IMPORTANT SAFETY INFORMATION
WARNINGS AND PRECAUTIONS
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.
Patients taking proton pump inhibitors, H2-receptor antagonists, or antacids concomitantly with MYCAPSSA may require increased dosages of MYCAPSSA.
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.
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