Benzinga | Jul 27, 2020 04:05PM EDT

UPDATE: Chiasma Says Mean Of IGF-1 Levels For Population Of All MYCAPSSA-Treated Patients That Completed 36-Week Core CHIASMA OPTIMAL Trial And Continued Into OLE 'was maintained within normal limits at the end of the 48-week OLE period'

-- 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(r) (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 (n=19) 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 (n=20) completed the 48-week OLE period.

* All patients that enrolled into the OLE as responders to MYCAPSSA (IGF-1 within normal limits, n=14) 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 Chiasma's Transient Permeability Enhancer (TPE(r)) technology.