Loading, Please Wait...
WALTHAM, Mass., March 21, 2019 (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 three poster presentations at ENDO 2019: The Endocrine Society’s Annual Meeting and Expo, which is being held March 23-26 in New Orleans.
William Ludlam, MD, PhD, Senior Vice President of Clinical Development and Medical Affairs, said, “We are pleased to present three posters at ENDO this year to further educate the endocrinology community on the ongoing challenges associated with the maintenance treatment of adults suffering from acromegaly. These presentations highlight the significant and persistent need for new treatment alternatives in this patient population.”
Mark Fitzpatrick, Chief Executive Officer of Chiasma, commented, “Our octreotide capsules product candidate, which we have conditionally trade named MYCAPSSA®, is currently being evaluated in two Phase 3 clinical trials and, if approved, could represent a new treatment paradigm by being the first orally-administered somatostatin analog. We look forward to releasing top-line data from the first of these two important Phase 3 trials – CHIASMA OPTIMAL – during the third quarter of 2019, and assuming positive data, will form the basis of a planned U.S. NDA submission by the end of this year.”
Details of the poster presentations are:
|Title:||Patient Reported Outcome Data from Acromegaly Patients Treated with Injectable Somatostatin Analogues in Routine Clinical Practice: Preliminary Results|
|Date:||Saturday, March 23, 2019|
|Location:||Poster Board # SAT-434, Ernest N. Morial Convention Center, Expo Hall|
This poster describes a two-staged study in which U.S. acromegaly patients treated within the past year, receiving a stable dose of long-acting somatostatin analog injections (SSAs), completed an online survey focusing on disease characteristics, routine management, symptoms, adverse drug reactions, treatment satisfaction and general health. Their treating physicians were then interviewed to understand differences in perspective between patients and providers.
|Title:||Relationship between Responses from Acromegaly Patients Treated with a Stable Dose of Injectable Somatostatin Analogues in Routine Clinical Practice and their Endocrinology Health Care Professional Regarding Treatment Outcomes: Preliminary Findings|
|Date:||Sunday, March 24, 2019|
|Location:||Poster Board # SUN-LB077, ENDOExpo Hall, Ernest N. Morial Convention Center|
This poster describes the results of a study of 30 acromegaly patients who received a stable dose of long-acting SSA injections for the past year and completed the Acro-TSQ survey focused on disease characteristics. These included routine management, symptoms, adverse reactions, general health, side effect interference, bother and convenience. Results were then compared to disease characteristics as reported by their treating physicians to identify areas of concordance.
|Title:||Biochemically Controlled Acromegaly Patients on a Stable Dose of Injectable Somatostatin Analogues in Routine Clinical Practice Still Remain Symptomatic: Preliminary Results From Endocrinology Health Care Professionals|
|Date:||Sunday, March 24, 2019|
|Location:||Poster Board # SUN-LB078, ENDOExpo Hall, Ernest N. Morial Convention Center|
This poster describes a two-staged study designed to understand how endocrinology health professionals perceive their acromegaly patients’ treatment outcomes. Patients on a stable dose of injectable SSAs for the past year completed the Acro-TSQ survey focused on disease characteristics. These included biochemical control, symptom control and interference, adverse reactions, general health, side effect interference, treatment satisfaction, bother, and convenience. Their treating physicians were then interviewed to provide their perception of each individual patient’s outcome to identify areas of concordance.
After the presentations at ENDO2019, the posters will be available on the Events and Presentations section of Chiasma’s company website at: www.chiasmapharma.com.
CHIASMA OPTIMAL Phase 3 Trial
The CHIASMA OPTIMAL trial is a randomized, double-blind, placebo-controlled, nine-month clinical trial of octreotide capsules being conducted under a SPA agreement with the FDA. The trial enrolled 56 adult acromegaly patients whose disease was biochemically controlled, based upon levels of IGF-1, a byproduct of increased growth hormone (GH) levels caused by acromegaly, by injectable somatostatin receptor ligands at baseline (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. The trial was randomized on a 1:1 basis, octreotide capsules versus 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 who meet predefined withdrawal criteria or withdraw from oral treatment in either treatment arm for any reason during the course of the trial will be considered treatment failures; those patients will be offered their original treatment of injections and 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 anticipates the release of top-line data from this Phase 3 clinical trial in the third quarter of 2019.
MPOWERED™ Phase 3 Trial
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 plans to enroll up to 150 adult acromegaly patients into the trial, of which at least 80 patients who are responders to octreotide capsules following a six-month run-in will be randomized to either octreotide capsules or injectable somatostatin receptor ligands (octreotide LAR or lanreotide autogel), and then followed for an additional nine months. The trial was initiated in March 2016, has enrolled 135 patients as of July 2018 (of which the EMA-required minimum of 80 responder patients have been randomized) and 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. In November 2018, Chiasma announced that it had elected to resume enrollment in the trial in an effort to enroll up to 15 additional patients exclusively located in the United States in order to gain further U.S. investigator and patient experience with octreotide capsules. Chiasma now anticipates the trial to complete enrollment into the run-in phase in the second quarter of 2019 and expects to release top-line data from this Phase 3 clinical trial during the second half of 2020.
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. In October 2018, the Company completed enrollment in 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. Prior to trial initiation, the Company reached agreement with the FDA on the design of the trial through a special protocol assessment. 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 Company’s efforts to potentially obtain regulatory approval in the European Union by conducting the ongoing MPOWERED Phase 3 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 during 3Q 2019, the Company’s plans to submit its NDA by the end of 2019, and the Company’s ability to release top-line data from the MPOWERED trial during the second half of 2020. 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 Annual Report on Form 10-K for the year ended December 31, 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.
Ashley R. Robinson
LifeSci Advisors, LLC