According to Financial Buzz Chiasma, Inc. has reached a new clinical stage in its development of a treatment for acromegaly. The trial, known as CHIASMA OPTIMAL, tests a treatment currently being referred to as MYCAPSSA. As of June 14th the Phase 3 clinical trial reached 50% patients randomized. Keep reading to learn more, or follow the original story here for additional information.
Acromegaly is a hormonal condition which is estimated to affect about 60 people in every million. Acromegaly is a hormone disorder in which excess amounts of growth hormone (GH) causes significant, abnormal growth. This is typically caused by noncancerous tumors, called adenomas, that affect the pituitary gland.
CHIASMA OPTIMAL is a Phase 3 clinical trial being conducted with 50 adult patients with acromegaly. The trial will last nine months, using a randomized, double-blind, placebo-controlled model. Chiasma predicts that the trial will finish its randomization at the end of the year. Chiasma set out a timeline for the clinical trial at the onset and appears to be matching expectations for the completion of the study.
Top-line results are expected to be released sometime in the fourth quarter of 2019.
MYCAPSSA, the treatment being tested, is planned to be used for the maintenance therapy of acromegaly in adult patients. The MYCAPSSA treatment involves the use of octreotide capsules which is an investigational, orally administered version similar to the current injection treatment for acromegaly (somatostatin).
Currently the Chiasma clinical trial continues under a Special Protocol Assessment (SPA) alongside the United States Food and Drug Administration (FDA).
During this process, the FDA works with Chiasma to agree upon certain requirements and indicators that must be met before the trial begins. These requirements and expectations help determine whether or not the investigational treatment and trial will meet the further regulatory standards of the FDA.
Chiasma’s CEO, Mark Fitzpatrick, says that his company is encouraged by the significant clinical progress the acromegaly treatment is making.
He says that getting to the midway point of this randomization process is a major step towards resubmitting their New Drug Application with the FDA. Furthermore, Fitzpatrick claims that the milestone Chiasma has reached in the octreotide capsule trial helps demonstrate the progress being made towards a treatment for the acromegaly.