Chiasma, Inc. announced resubmission of its new drug application to the United States Food and Drug Administration. On January 10, 2020, the Company resubmits its new drug application (“NDA”) to the United States Food and Drug Administration (“FDA”) seeking marketing approval for its investigational octreotide capsules product candidate, conditionally trade-named MYCAPSSA, for the maintenance treatment of adults with acromegaly. Following the anticipated approval of the NDA by the FDA, the Company expects to submit two manufacturing supplements to the NDA to provide for an additional active pharmaceutical ingredient (“API”) manufacturer and an additional commercial-scale manufacturing site affiliated with the API manufacturer currently referenced in the NDA. These manufacturing sources were not included in the NDA resubmission in order to allow for further time for the additional API manufacturer not referenced in the NDA to resolve observations from a recent regulatory inspection and to allow the Company to seek the FDA’s designation of the resubmission of the NDA as a Class 2 resubmission, which typically entails a six-month review period. The Company is currently procuring API from both sources in anticipation of an NDA approval and, subject to FDA’s timely approval of the NDA and either of the manufacturing supplements, expects to have oral octreotide product available to support its planned commercial launch in the fourth quarter of 2020. The CHIASMA OPTIMAL trial was a randomized, double-blind, placebo-controlled, nine-month Phase 3 clinical trial of octreotide capsules that was conducted under a SPA agreement with the FDA. The trial enrolled 56 adult acromegaly patients whose disease was biochemically controlled by injectable somatostatin analogs (average IGF-1 = 1.0 × upper limit of normal (ULN)). The patients also had confirmed active acromegaly following their last surgical intervention based upon an elevated IGF-1 at that time of = 1.3 × ULN. Patients were randomized on a 1:1 basis, to octreotide capsules or placebo. Patients were dose titrated from 40 mg per day to up to a maximum of 80 mg per day, equaling two capsules in the morning and two capsules in the evening. Patients who met the predefined withdrawal criteria, or discontinued from oral treatment for any reason, in either treatment arm during the course of the trial were considered treatment failures and reverted to their original treatment of injections and monitored for the remainder of the trial. The primary endpoint of the trial was the proportion of patients who maintained their biochemical response at the end of the nine-month, double-blind, placebo-controlled period as measured using the average of the last two IGF-1 levels =1.0 × ULN (assessed at weeks 34 and 36). Hierarchical secondary endpoints that are expected to be considered by the FDA in evaluating the totality of evidence for octreotide capsules treatment include: proportion of patients who maintain GH response at week 36 compared to screening; time to loss of response: IGF-1 of 2 consecutive visits is > 1.0 × ULN; time to loss of response: IGF-1 of 2 consecutive visits is = 1.3 × ULN; and proportion of patients requiring rescue treatment. Chiasma is also conducting an international Phase 3 clinical trial under a protocol accepted by the EMA for the company’s octreotide capsules product candidate for the maintenance therapy of adult patients with acromegaly. The trial, referred to as MPOWERED, is a global, randomized, open-label and active-controlled, 15-month trial intended to support approval in the European Union. Chiasma completed enrollment of 146 adult acromegaly patients into the trial in June 2019, of which 92 patients who are responders to octreotide capsules per the protocol following a six-month run-in were randomized to either octreotide capsules or injectable somatostatin receptor ligands (octreotide LAR or lanreotide autogel) and are being followed for an additional nine months. The trial is designed to evaluate the proportion of patients who maintain their biochemical response to octreotide capsules and patient-reported outcomes in patients treated with octreotide capsules, compared to patients treated with standard of care injectable somatostatin receptor ligands. Chiasma expects to release top-line data from the MPOWERED Phase 3 clinical trial during the fourth quarter of 2020. Company anticipates that within 30 days of its NDA resubmission the FDA will determine whether the NDA is complete and ready for review and provide the review timeline.