Chiasma (NASDAQ:CHMA) reported positive top-line Phase 3 data from a pivotal trial evaluating its octreotide candidate, conditionally trade-named Mycapssa, for the treatment of acromegaly.
Acromegaly is caused by the overproduction of growth hormone, which Mycapssa – and oral synthetic somatostatin analogue – is designed to inhibit.
The trial, which was conducted under a special protocol assessment, met its primary endpoint: 58% of patients taking Mycapssa maintained their insulin-like growth factor response, compared with 19% of patients taking placebo. The trial also met all of its secondary endpoints.
“The FDA previously indicated that this trial is adequately designed to address the clinical deficiency listed in their complete response letter, subject to their review,” Dr. Gary Patou, Chiasma’s head of clinical, said in a statement.
“We look forward to working with the FDA to bring this important treatment option to patients,” he added.
Chiasma hopes to file an NDA for Mycapssa to the FDA by the end of 2019.