Conference call and webcast scheduled for 5 p.m. ET today
WALTHAM, Mass., May 14, 2018 (GLOBE NEWSWIRE) — Chiasma, Inc. (NASDAQ:CHMA), a clinical-stage biopharmaceutical company focused on improving the lives of patients with rare and serious chronic diseases, today announced it has reached agreement with the U.S. Food and Drug Administration (FDA) to redefine certain secondary endpoints of its recently initiated CHIASMA OPTIMAL Phase 3 clinical trial for its octreotide capsules product candidate, conditionally trade-named MYCAPSSA®, for the maintenance therapy of adult patients with acromegaly. Chiasma has received a Special Protocol Assessment (SPA) Agreement Modification letter from the FDA to formalize these changes.
“We believe the SPA Modification agreement we are announcing today with the FDA favorably alters the mix of secondary endpoints to be reviewed by the FDA in evaluating the totality of evidence of octreotide capsules’ treatment effect,” said Mark Fitzpatrick, president and CEO of Chiasma. “Through the SPA Agreement Modification, the original fourth and fifth secondary endpoints in this pivotal Phase 3 trial have now been redefined to descriptive statistics measured within each treatment group. The Special Protocol Assessment for the CHIASMA OPTIMAL Phase 3 trial indicates the FDA’s agreement that this Phase 3 clinical trial is appropriately designed to form the primary basis of an efficacy claim.”
SPA Agreement Modification
Chiasma has reached agreement with the FDA, through a SPA Agreement Modification letter, to redefine certain secondary endpoints of its recently initiated CHIASMA OPTIMAL Phase 3 clinical trial for its octreotide capsules product candidate, conditionally trade-named MYCAPSSA®, for the maintenance therapy of adult patients with acromegaly. Per the SPA Agreement Modification letter, the new hierarchical secondary endpoints now include:
- Proportion of patients who maintain growth hormone (GH) response at week 36, compared to screening;
- Time to loss of response of IGF-1 > 1.0 × upper limit of normal (ULN);
- Time to loss of response of IGF-1 > 1.3 × ULN; and
- Proportion of patients requiring rescue treatment.
Chiasma had previously communicated that it did not believe that the superiority of MYCAPSSA would have been demonstrated in two defined secondary endpoints under the original trial design. Prior to the SPA modification, the last two defined secondary endpoints (change from screening to end of treatment in mean GH and the change in IGF-1 from baseline to end of treatment), would have compared patients’ response in the octreotide capsules treatment arm to patients’ response in the placebo treatment arm where the Company expects a significant number of patients to have withdrawn to injectable somatostatin analog rescue therapy. Under the SPA Agreement Modification, between-arm comparisons of these two descriptive measures will not be made. The Company believes that this modification agreement is important, because the FDA has indicated it plans to consider the secondary endpoints in its evaluation of the totality of evidence of oral octreotide’s treatment effect. In addition, the original trial design also included as an exploratory endpoint the proportion of patients requiring rescue treatment in each treatment arm during the nine-month, double-blind, placebo-controlled phase. Chiasma requested, and the FDA has agreed, to move that exploratory endpoint to the fourth and final secondary endpoint in the hierarchy.
CHIASMA OPTIMAL Phase 3 Trial
Chiasma is conducting a randomized, double-blind, placebo-controlled, nine-month clinical trial in 50 adult acromegaly patients (at least 20% of whom must be recruited from the United States) whose disease is biochemically controlled, based upon levels of IGF-1, a byproduct of increased GH levels caused by acromegaly, on injectable somatostatin analogs at baseline (average IGF-1 ≤ 1.0 × upper limit of normal (ULN)). The patients also must have confirmed active acromegaly following their last surgical intervention based upon an elevated IGF-1 at that time of ≥ 1.3 × ULN. The trial is being randomized on a 1:1 basis to octreotide capsules or placebo. Patients are being 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 meeting predefined biochemical failure criteria in either treatment arm during the course of the trial will be considered treatment failures and revert to their original treatment of injections and will be monitored for the remainder of the trial. The primary endpoint of the trial is the proportion of patients who maintain their biochemical response compared to placebo 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. Chiasma currently has 40 clinical sites activated in CHIASMA OPTIMAL and continues to anticipate more than 50 clinical sites will be dedicated to CHIASMA OPTIMAL. Chiasma anticipates the release of top-line data from this Phase 3 clinical trial by the end of 2019.
Conference Call Information
Chiasma will conduct an investor conference call to discuss the Special Protocol Assessment Agreement Modification and the CHIASMA OPTIMAL clinical trial at 5:00 p.m. ET today. A live webcast of the call will be available in the “News & Investors” section of www.chiasma.com. The call also may be accessed by dialing (877) 604-1612 or (201) 389-0883. A webcast replay will be available following the call.
Chiasma is focused on improving the lives of patients who face challenges associated with their existing treatments for rare and serious chronic diseases. Employing its Transient Permeability Enhancer (TPE®) technology platform, Chiasma seeks to develop oral medications that are currently available only as injections. The Company recently initiated CHIASMA OPTIMAL, its third Phase 3 clinical trial for its octreotide capsules product candidate, conditionally trade-named MYCAPSSA®, for the maintenance therapy of adult patients with acromegaly in whom prior treatment with somatostatin analogs has been shown to be effective and tolerated following agreement with the FDA on the design of the trial. Chiasma is headquartered in Waltham, MA with a wholly owned subsidiary in Israel. MYCAPSSA, TPE and CHIASMA are registered trademarks of Chiasma. For more information, please visit the Company’s website at www.chiasma.com.
This release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, including, but not limited to, statements regarding the Company’s development of octreotide capsules, conditionally named MYCAPSSA, for the treatment of acromegaly, the Company’s efforts to potentially obtain regulatory approval in the United States by conducting the Phase 3 CHIASMA OPTIMAL clinical trial under a Special Protocol Assessment, the number of clinical sites that will be dedicated to the CHIASMA OPTIMAL clinical trial, the timing of receipt and announcement of top-line and other clinical data and submission of regulatory filings, including the Company’s ability to release top-line data from the CHIASMA OPTIMAL trial by the end of 2019. Any forward-looking statements in this press release are based on management’s current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. For a discussion of these and other risks and uncertainties, and other important factors, any of which could cause our actual results to differ from those contained in the forward-looking statements, see the section entitled “Risk Factors” in Chiasma’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2018 filed with the Securities and Exchange Commission (SEC) on May 10, 2018, and in subsequent filings with the Securities and Exchange Commission. All information in this press release is as of the date of the release, and Chiasma undertakes no duty to update this information unless required by law.
Sharon Merrill Associates