Chiasma CEO says 2019 was a 'successful year'
Chiasma reviewed its 2019 highlights and previewed its anticipated 2020 corporate milestones. On December 26, Chiasma resubmitted its NDA to the U.S. Food and Drug Administration for its investigational octreotide capsules product candidate, MYCAPSSA, for the maintenance treatment of adults with acromegaly. The positive results from the CHIASMA OPTIMAL trial, which was conducted under a Special Protocol Assessment agreement with the FDA, support the NDA resubmission. Chiasma expects a six-month review of the NDA resubmission. The NDA resubmission marks an important milestone in the company's effort to bring an oral somatostatin analog to patients. Following anticipated NDA approval, and in order to have commercial supply of MYCAPSSA product for launch, Chiasma expects to submit two manufacturing supplements to provide for an additional active pharmaceutical ingredient manufacturer and an additional commercial-scale manufacturing site affiliated with the API manufacturer currently referenced in the NDA. Chiasma is currently procuring API from both sources in anticipation of NDA approval. Chiasma expects to have adequate product available to support its planned commercial launch in the fourth quarter of 2020, subject to FDA's timely approval of the NDA and either of the manufacturing supplements. In July, Chiasma announced that the primary endpoint of the CHIASMA OPTIMAL trial, the proportion of patients biochemically controlled at the end of the trial, was achieved. Additionally, all four secondary endpoints were met. The CHIASMA OPTIMAL trial was conducted under an SPA agreement with the FDA and evaluated MYCAPSSA for the maintenance treatment of adults with acromegaly. Three Posters Presented at ENDO 2019 Highlighted Significant Unmet Needs in U.S. Acromegaly Patients: Data presented concluded that patients currently treated on injectable somatostatin analog therapies experience a significant disease burden and treatment dissatisfaction even when biochemically-controlled using existing therapies. The MPOWERED trial, designed to support approval of MYCAPSSA in the European Union for acromegaly, completed enrollment in June 2019. As of January 2020, the randomization was completed. Responders to the octreotide capsules were randomized per the protocol into the nine-month randomized controlled phase. Chiasma began its transformation into a commercial-ready organization with the appointment of a commercially-experienced chief executive officer and the addition of experienced leaders in marketing, market access and patient services. Chiasma has also expanded its medical affairs function, including hiring a leader with strategic medical and scientific expertise. "2019 was a successful year for Chiasma, highlighted by the positive results from the Phase 3 CHIASMA OPTIMAL trial and the NDA resubmission," said CEO Raj Kannan. "Looking ahead, 2020 has the potential to be a transformational year for our company as we focus on executing a successful launch of the first oral somatostatin analog for the treatment of acromegaly."