CHIASMA OPTIMAL Phase III trial of Mycapssa in acromegaly published in Journal of Clinical Endocrinology & Metabolism.- Chiasma

Chiasma announced the online publication of results from its CHIASMA OPTIMAL Phase III clinical trial of Mycapssa (octreotide oral) for acromegaly in the 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. The CHIASMA OPTIMAL trial (NCT03252353) was a randomized, double-blind, placebo-controlled, nine-month Phase III clinical trial to evaluate the efficacy and safety of octreotide capsules in patients with acromegaly who previously demonstrated biochemical control while receiving injectable somatostatin analogs (SSA), namely octreotide LAR or lanreotide depot. 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. See: "Maintenance of Acromegaly Control in Patients Switching From Injectable Somatostatin Receptor Ligands to Oral Octreotide" Susan L Samson et al. The Journal of Clinical Endocrinology & Metabolism, 16 August 2020 dgaa526, https://doi.org/10.1210/clinem/dgaa526