The US Food and Drug Administration (FDA) has agreed on biopharmaceutical firm Chiasma’s new Phase III clinical trial (OPTIMAL) design to evaluate its octreotide capsules product candidate Mycapssa as a maintenance therapy to treat adults with acromegaly.
Developed using the firm’s Transient Permeability Enhancer (TPE) technology platform, the octreotide capsules are intended to bind to receptors on specialised cells in the pituitary gland for minimising growth hormone (GH) production.
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The new trial design will address previous concerns raised by the FDA in April last year, when the agency advised the firm to perform an additional clinical trial to obtain substantial evidence of the product candidate’s efficacy.
Chiasma reached the trial design agreement through Special Protocol Assessment (SPA) with the FDA’s Metabolism and Endocrinology Products division.
Planned to enrol 50 patients, the randomised, double-blind, placebo-controlled, nine-month OPTIMAL trial will measure the levels of IGF-1 growth factor as the primary endpoint.
Chiasma president and CEO Mark Fitzpatrick said: “The SPA indicates the agency’s agreement that our planned new Phase III clinical trial is appropriately designed to form the primary basis of an efficacy claim.
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By GlobalData“It is a critical milestone in the continued development of octreotide capsules and provides regulatory clarity to enable us to resubmit our new drug application (NDA) if the trial’s primary endpoint is achieved.”
During the Phase III trial, subjects will be dose titrated from 40mg per day up to 80mg per day, equivalent to two capsules in the morning and two capsules in the evening.
Enrolment for the trial is expected to begin in the coming months and the top-line results are expected to be reported by the end of 2019.
