Chiasma Announces Publication of Pivotal Data from the Phase 3 CHIASMA OPTIMAL Clinical Trial in the Journal of Clinical Endocrinology & Metabolism

NEEDHAM, Mass., Aug. 17, 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 the online publication of its CHIASMA OPTIMAL (Octreotide capsules vs. Placebo Treatment In MultinationAL centers) Phase 3 clinical trial results in the prestigious endocrinologist-focused Journal of Clinical Endocrinology & Metabolism. The publication, entitled, “Maintenance of acromegaly control in patients switching from injectable somatostatin receptor ligands to oral octreotide therapy,” was lead authored by Susan Samson, M.D., Ph.D., FRCPC, FACE, who served as principal investigator of the CHIASMA OPTIMAL clinical trial.

“We are honored that the results from our Phase 3 CHIASMA OPTIMAL trial will be published in the Journal of Clinical Endocrinology & Metabolism,” said William Ludlam, M.D., Ph.D., senior vice president of clinical development and medical affairs at Chiasma. “This publication in a top tier respected journal provides validation in the scientific community of our pivotal study results and the potential benefits MYCAPSSA could bring to patients with acromegaly.  We would like to thank the authors, investigators, staff and, most importantly, patients that participated in this study for their help in bringing a novel, non-injectable oral option to those living with acromegaly.”

The CHIASMA OPTIMAL trial (NCT03252353) was a randomized, double-blind, placebo-controlled, nine-month Phase 3 clinical trial to evaluate the efficacy and safety of MYCAPSSA (octreotide) capsules in patients with acromegaly who previously demonstrated biochemical control while receiving injectable somatostatin analogs (SSA), namely octreotide LAR or lanreotide depot. The trial enrolled 56 adult patients whose disease was biochemically controlled by SSA therapy based upon levels of IGF-1, a byproduct of increased growth hormone (GH), caused by acromegaly (average IGF-1 ≤ 1.0 × upper limit of normal (ULN)). Patients were randomized on a 1:1 basis, to MYCAPSSA 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).