Chiasma, Inc has achieved 50% patients randomized in its international phase 3 clinical trial, also referred to as “CHIASMA OPTIMAL,” of its octreotide capsules for acromegaly.
Chiasma, Inc. has achieved 50% patients randomized in its international phase 3 clinical trial, “CHIASMA OPTIMAL” (Octreotide capsules vs. Placebo Treatment In MultinationAL centers), for its octreotide capsules, trade-named Mycapssa, for the maintenance therapy of adult patients with acromegaly.
“We are encouraged by the clinical progress in our acromegaly program,” commented Mark Fitzpatrick, president and CEO of Chiasma in a recent statement. “Reaching the midway point for randomization in our CHIASMA OPTIMAL phase 3 trial is an important step toward our goal of resubmitting a New Drug Application with the US Food and Drug Administration (FDA).”
Acromegaly is characterized by the causation of a benign tumor of the pituitary gland that produces excess growth hormone, which ultimately leads to significant health problems and early morbidity if left untreated.
Octreotide capsules are believed to exhibit the effects of somatostatin, a naturally-occurring hormone that reduces the production of growth hormone by binding to receptors on specialized cells in the pituitary gland.
A randomized, double-blind, placebo-controlled, nine-month clinical trial, CHIASMA OPTIMAL is being conducted in 50 adult acromegaly patients—at least 20% of whom must be recruited from the United States—whose disease is biochemically controlled, according to levels of IGF-1, a byproduct of increased GH levels caused by acromegaly, on injectable somatostatin analogs at baseline (average IGF-1 ≤ 1.0 × upper limit of normal [ULN]).
Additional qualitative inclusion criteria include confirmed active acromegaly following the patient’s last surgical intervention based upon an elevated IGF-1 at time of ≥ 1.3 × ULN. Trial randomization is designed on a 1:1 basis to octreotide capsules or placebo.
Patients will be administered octreotide doses titrated from 40 mg per day to up to a maximum of 80 mg per day, equaling 2 capsules in the morning and 2 capsules in the evening. During the course of the trial, if patients meet predefined biochemical failure criteria in either treatment arm, they will be considered treatment failures and revert to their original treatment of injections and monitored for the trial remainder.
The proportion of patients who maintain their biochemical response compared with placebo at the end of the 9-month, double-blind, placebo-controlled period as measured using the average of the last two IGF-1 levels ≤ 1.0 × ULN is serving as the primary endpoint of the trial.
Currently, more than 50 clinical sites are anticipated to be dedicated to and participate in CHIASMA OPTIMAL.
“This enrollment milestone demonstrates the tangible progress we are making toward advancing octreotide capsules as a maintenance treatment for adult acromegaly patients,” added Fitzpatrick. “We strongly believe in Mycapssa as a potential new treatment option for adult patients with acromegaly.”
Under a Special Protocol Assessment (SPA) with the FDA’s Division of Metabolism and Endocrinology Products, the CHIASMA OPTIMAL trial is being conducted. Additionally, the CHIASMA OPTIMAL trial has obtained the FDA-required minimum of 10 patients randomized from the United States.
Complete randomization of the CHIASMA OPTIMAL trial is expected by the end of 2018, with top-line data expected to be released in Q4 2019.
Feature Picture Source: GreenFlames09 / flickr / Creative Commons.