Chiasma reaches agreement with FDA for Phase 3 OPTIMAL trial
Chiasma announced it has reached agreement with the FDA on the design of a new Phase 3 clinical trial for its octreotide capsules product candidate, conditionally trade-named Mycapssa, for the maintenance therapy of adult patients with acromegaly. The agreed-upon study is designed to address the concerns previously raised in the FDA's complete response letter and was reached through special protocol assessment with the FDA's Division of Metabolism and Endocrinology Products. The trial, referred to as OPTIMAL, is a randomized, double-blind, placebo-controlled, nine-month trial in 50 adult acromegaly patients. OPTIMAL utilizes levels of insulin-like growth factor, IGF-1, a byproduct of increased growth hormone levels caused by acromegaly, as the sole primary endpoint measure. The company anticipates release of top-line data from this new Phase 3 clinical trial by the end of 2019. The company continues to enroll patients in its international Phase 3 MPOWERED clinical trial of octreotide capsules for the maintenance treatment of adult patients with acromegaly to potentially support regulatory approval in Europe. However, in order to support enrollment rates for the OPTIMAL Phase 3 clinical trial, Chiasma has significantly reduced the number of sites enrolling patients in the MPOWERED trial.