In very recent news, the biopharmaceutical company Chiasma, Inc. announced that it has come to an agreement with the US FDA regarding the design of a phase III clinical trial for a new acromegaly treatment, Mycapssa (octreotide capsules).
The study was tweaked and adjusted after the FDA’s Complete Response Letter (CRL) addressed some concerns, and the altered version was agreed-upon through Special Protocal Assessment (SPA) with the FDA’s Division of Metabolism and Endocrinology Products.
The trial will be called “OPTIMAL” which stands for Octreotide capsules vs. Placebo Treatment In MultinationAL centers, and will be a double-blind, placebo-controlled, randomized, 9-month long trial that assesses 50 adult acromegaly patients.
The primary endpoint measure of this study will be levels of insulin-like growth factor, IGF-1, which is a byproduct of increased growth hormone (GH) levels caused by acromegaly. The biopharmaceutical company is expecting data from this phase III trial by the end of 2019.
Under the Special Protocol Assessment (SPA), Chiasma and the FDA came to an agreement on the clinical trial protocol design, endpoints and analysis of the study before the study could take root. This is necessary for the FDA to determine if the study will properly address the scientific and regulatory requirements for approval.
Octreotide capsules, the treatment in question, are a new oral drug that is proposed to be a maintenance therapy for adult patients with acromegaly. If the treatment is approved, these capsules could be the first oral somatostatin analog treatment on the market for patients with acromegaly. At the moment, the standard of care is somatostatin analog in the form of injections.
Needless to say, if this phase III trial goes smoothly and the treatment eventually gets approved and available to the public, it will make the lives of adult acromegaly patients a lot easier. Capsules are always more convenient than injections, and less uncomfortable too, so we’re looking forward to seeing where these trials lead to.
By 2019, we should have some answers. To read more about this new FDA agreement, check it out in Globe Newswire here..