Chiasma has completed patient enrolment in its Phase lll CHIASMA OPTIMAL clinical trial evaluating octreotide capsules for the treatment of adult patients with acromegaly.
The randomised, double-blind, placebo-controlled, nine-month clinical trial has enrolled 56 patients, including 21 in the US, across 17 countries worldwide.
The patients’ disease was biochemically controlled and confirmed active acromegaly following their last surgical intervention based upon levels of IGF-1.
During the trial, patients were randomised in a 1:1 ratio to receive various doses of octreotide capsules starting from 40mg to a maximum of 80mg a day, and placebo.
Patients who meet the trial’s predefined withdrawal criteria in either of the treatment arm will be considered treatment failures. They will go back to their original treatment of injections and will be observed during the remaining course of the trial.
The trial’s primary endpoint is the proportion of patients who maintain their biochemical response compared to placebo at the end of the nine-month, double-blind, placebo-controlled period.
Top-line data from the trial is expected to be released in September next year.
The trial is being carried out under a special protocol assessment (SPA) agreement reached between Chiasma and the US Food and Drug Administration (FDA) in support of a potential regulatory approval of the octreotide capsules, conditionally trade-named MYCAPSSA.
Chiasma CEO Mark Fitzpatrick said: “The current standard of care for patients living with acromegaly, injectable somatostatin analogs, carries significant treatment burdens in many patients.
“These burdens underscore the need for an orally administered treatment option, and we believe octreotide capsules, if approved, can potentially address some of these issues.”
Acromegaly is a disorder caused by excess growth hormone (GH) following the closing of the growth plates.
It may lead to enlargement of hands and feet, forehead, jaw, and nose.