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).Results from the study demonstrated that average IGF-1 levels were within the normal range (0.97 X upper limit of normal (ULN)) for all patients receiving MYCAPSSA at the end of the treatment compared to patients receiving placebo (1.69 X ULN). Growth hormone levels were maintained (< 2.5 ng/mL) in 77.7% of the MYCAPSSA group versus 30.4% in the placebo group (P=0.0007). Patients in the MYCAPSSA group, 75% (21/28) successfully completed the trial after 36 weeks and did not require reversion to prior injectable treatment. Most patients that reverted to injectable SSA re-established their baseline response levels after a single dose of injectable SSA suggesting that, in the clinical setting, those patients who fail to respond on treatment with MYCAPSSA may be able to quickly and safely revert to prior therapy, if necessary. The data from the study demonstrated that MYCAPSSA was well tolerated, and no new or unexpected safety signals were observed.The full pre-print publication can be accessed at:https://academic.oup.com/jcem/advance-article/doi/10.1210/clinem/dgaa526/5892992In 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.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.
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