According to a story from globenewswire.com, the biopharmaceutical company Chiasma, Inc., recently announced that it has completed the enrollment of 135 patients for its Phase 3 clinical trial. This trial will test octreotide capsules as a maintenance therapy for acromegaly in adults. Chiasma is dedicated to developing therapies for serious, rare, chronic illnesses. If the trial results are positive, the company hopes that the capsules will gain approval for public use in the EU.
Acromegaly is a rare disorder characterized by the presence of excess growth hormone after the growth plates of bones have closed. This condition is not heritable, but is usually linked to the pituitary gland producing a higher than normal amount of the hormone. In the vast majority of cases, this is due to a benign tumor called a pituitary adenoma. The condition causes a very distinct physical appearance, including features such as pronounced forehead, jaw, and nose, and large hands and feet. Other symptoms include thickened skin, deep voice, carpal tunnel syndrome, headache, enlarged heart, hypertension, kidney failure, and heart failure. Without treatment, lifespan can be reduced by about a decade on average, but successful treatment resolves symptoms and lifespan is unaffected. To learn more about acromegaly, click here.
The success of the trial would give acromegaly patients a new and more convenient treatment option that would offer quality of life improvements over current standards. Maintenance therapy for acromegaly typically involves the injection of somostatin analogues, but octreotide can be taken by mouth, and should theoretically retain comparable effectiveness. The drug follows the trend of Chiasma’s development approach, which often involves attempting to make drugs that are currently only available as injections into an orally active format.
The Clinical Trial
The clinical trial is projected to be completed in late 2019, with top-line data from the study available early the following year. The trial will last a total of 15 months, and will compare the effectiveness and safety of octreotide to somostatin injections. If approved, the drug would be the first orally active somostatin analogue available to acromegaly patients in the EU. Hopefully, the trial will demonstrate the effectiveness and safety of octreotide capsules, and the experimental drug will gain approval.