FDA Approves Chiasma, Oral Treatment for Acromegaly

As reported in Crwe World; the biopharmaceutical company Chiasma aims to create oral consumed therapies in order to provide acromegaly patients who have a chronic need for injections with an easier method. Now, they’ve just announced results from the Phase 3 trials of their study entitled CHIASMA OPTIMAL (Octreotide capsules vs. Placebo Treatment IMultinationAL centers), which tested how patients reacted when switching from an injectable to oral octreotide therapy. Their successful results can be found in the prestigious “Journal of Clinical Endocrinology & Metabolism,” and the drug received FDA approval in June of 2020 as a result. 

Acromegaly is rare hormonal disease that causes patients to experience too much of the growth hormone (GH). This hormone can cause noncancerous tumors on the pituitary gland, the organ that produces it. Symptoms include strange growths in their hands and feet and changes enlarging the bones in their brow, nose, and mouth. The disorder typically develops in adulthood, but left untreated, can become dangerous or lethal.

Success in the Phase 3 Trial

The latest round on the Phase 3 trial, the final and most pertinent phase, found patients received the treatment successfully. The 56 patients enrolled in the trial were randomly assigned which drug they received in a double-blind and placebo-controlled method. The trial took place over nine months, in which patients either received an oral therapy or placebo treatment for acromegaly. The patients receiving the capsules demonstrated that all of the patients receiving the trial drug had similar outcomes in growth hormone levels when the treatment was administered orally, with 78% of the oral-administered taking group showing positive results, versus 30.4% of the placebo-receiving group. They also found the patients had no difficulty reverting rapidly and without issue back to their previous treatment. 

Share this post