Chiasma is conducting clinical trials of octreotide capsules (conditionally trade named Mycapssa®) for the maintenance therapy of adult patients with acromegaly in whom prior treatment with somatostatin analogs has been shown to be effective and tolerated.

CHIASMA OPTIMAL Phase 3 Trial

In June 2019, Chiasma completed an international Phase 3 trial of octreotide capsules (conditionally trade named Mycapssa®) for the maintenance treatment of adults with acromegaly.

The trial, referred to as “CHIASMA OPTIMAL” (Octreotide capsules vs. Placebo Treatment In MultinationAL centers), was a randomized, double-blind, placebo-controlled, nine-month Phase 3 clinical trial of octreotide capsules that was conducted under a Special Protocol Assessment (SPA) agreement with the U.S. Food and Drug Administration (FDA). The trial was designed to evaluate the proportion of patients who maintain their biochemical response to octreotide capsules compared to placebo.

The company completed enrollment with 56 adult acromegaly patients in the CHIASMA OPTIMAL trial in October 2018 and completed the trial in June 2019. Positive topline results were reported in July 2019. The pivotal trial met its primary endpoint and all four secondary endpoints. Patients completing the trial were given the option of continuing on Mycapssa through the Open Label Extension (OLE) phase.

To learn more about CHIASMA OPTIMAL, please visit  https://clinicaltrials.gov/ct2/show/NCT03252353.

MPOWERED™ Phase 3 Trial

Chiasma is currently conducting an international Phase 3 clinical trial under a protocol accepted by the European Medicines Agency (EMA), designed to support approval of octreotide capsules (conditionally trade named Mycapssa®) in the European Union for the maintenance therapy of adult patients with acromegaly.

The trial, referred to as MPOWERED™ (Maintenance of acromegaly Patients with Octreotide capsules compared With injections – Evaluation of REsponse Durability), is a global, randomized, open-label and active-controlled, 15-month trial intended to support approval in the European Union.

Chiasma completed enrollment of 146 adult acromegaly patients into the trial in June 2019, of which 92 patients who are responders to octreotide capsules per the protocol following a six-month run-in were randomized to either octreotide capsules or injectable somatostatin receptor ligands (octreotide LAR or lanreotide autogel) and are being followed for an additional nine months. The trial is designed to evaluate the proportion of patients who maintain their biochemical response to octreotide capsules and patient-reported outcomes in patients treated with octreotide capsules, compared to patients treated with standard of care injectable somatostatin receptor ligands. Chiasma expects to release top-line data from the MPOWERED Phase 3 clinical trial during the fourth quarter of 2020.

To learn more about MPOWERED, please visit https://clinicaltrials.gov/ct2/show/NCT02685709.

CH-ACM-01 Phase 3 Trial

In November 2014, Chiasma completed a multinational, open-label Phase 3 clinical trial of oral octreotide capsules for the treatment of acromegaly.

The trial was a multi-center, open-label, baseline-controlled clinical trial to evaluate the safety and efficacy of octreotide capsules in patients with acromegaly who responded to and tolerated treatment with somatostatin analogs.

Chiasma enrolled 155 patients with acromegaly in this trial which was completed in November 2014. Applying a last-observation carried forward, or LOCF, methodology, 65 percent of patients in the mITT group were classified as responders at the end of the seven-month core treatment phase, which was the primary endpoint for the trial.

To learn more about MPOWERED, please visit https://clinicaltrials.gov/ct2/show/NCT01412424.