Among the initial findings, some acromegaly patients managed by injectable somatostatin receptor ligands (SRLs) report symptoms that may interfere with daily life
Treatment burden associated with injectable SRLs underscores need for an alternative administered treatment option
Screening data generated from Chiasma’s ongoing MPOWERED™ randomized Phase 3 trial of its investigational octreotide capsules product candidate, conditionally trade-named, MYCAPSSA®
WALTHAM, Mass., Sept. 13, 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 a poster presentation at the 9th International Congress of the Growth Hormone Research and IGF Societies (GRS & IGF), which is being held September 14-17, 2018 in Seattle, WA.
“For acromegaly patients with persistent disease following surgery, or for whom surgery is not an option, injectable somatostatin receptor ligands represent the current standard of care in the treatment of this rare but debilitating hormonal disorder,” commented William Ludlam, MD, PhD, Senior Vice President of Clinical Development and Medical Affairs at Chiasma. “However, the initial screening data from Chiasma’s MPOWEREDTM clinical trial detailed in this poster, in which 70 acromegaly patients self-reported the significant ongoing symptom burdens associated with their current injectable treatments, confirm that an alternative administered therapeutic option is sorely needed.”
Details of the poster session are as follows:
Title: Symptom burden in patients with acromegaly treated with injectable somatostatin receptor ligands
Presenting author: Dr. Murray Gordon, Division Director Endocrinology Allegheny Health Network
Poster #: 36 (late breaking abstract #242)
Date & time: Sunday, September 16, 2018, 11:30am-1:30pm PT
For more information on this poster presentation at GRS & IGF 2018, please visit: https://grs-igf2018.com/scientific/full-abstracts.aspx
This poster describes a method of assessing the ongoing symptoms and treatment burden of acromegaly patients receiving injectable somatostatin receptor ligands who are currently enrolled in Chiasma’s MPOWEREDTM global Phase 3, randomized, open-label study of its investigational octreotide capsule product candidate, which is conditionally trade-named MYCAPSSA®. Utilizing the Acromegaly Treatment Satisfaction Questionnaire (Acro-TSQ), a patient-reported symptom assessment tool developed and copyrighted by Chiasma, data from 70 eligible patients were collected and analyzed. Among the findings:
- 66% of patients reported ongoing acromegaly symptoms, of which 83% reported some symptoms “all the time.”
- 50% indicated some symptoms worsen towards the end of the monthly injection interval.
- Symptoms interfered with daily life (91%) and leisure activities (86%).
- More than 50% reported GI side effects (median duration five days following each injection) that interfered with daily life.
- GI side effects were worse in patients with more active symptoms but did not correlate with IGF-1 levels or treatment dose.
Conclusion
Despite being biochemically-controlled, some patients managed by injectable SRLs report acromegaly symptoms that interfere with daily life. A majority of patients were satisfied with SRL treatment overall; however, non-injection SRL options are not currently available. Analyses should be replicated once all screening data are available to confirm these initial findings.
“These initial data, which were derived from screening data from Chiasma’s ongoing MPOWERED randomized Phase 3 trial of investigational octreotide capsules, highlight some of the deficiencies of the current standard of care associated with injectable SRLs concerning treatment burden,” continued Dr. Ludlam. “We are optimistic that oral octreotide capsules, if approved, represent a potential advancement in the maintenance treatment of adult patients with acromegaly, and we look forward to our planned report of topline data from both of our ongoing randomized Phase 3 trials, CHIASMA OPTIMAL in 4Q 2019 and MPOWERED by early 2020.”
About Chiasma’s MPOWERED™ Phase 3 Trial
Chiasma is conducting an international Phase 3 clinical trial under a protocol accepted by the European Medicines Agency (EMA) for the Company’s octreotide capsules product candidate for the maintenance therapy of adult patients with acromegaly. The trial, referred to as MPOWEREDTM, is a global, randomized, open-label and active-controlled, 15-month trial intended to support approval in the European Union. Chiasma has enrolled 135 adult acromegaly patients into the trial, of which it expects to randomize at least 80 patients who are responders to octreotide capsules following a six-month run-in to either octreotide capsules or injectable somatostatin receptor ligands (octreotide or lanreotide), and then followed for an additional nine months. The trial was initiated in March 2016 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. Chiasma anticipates the trial to be completed in Q4 2019 and expects to release topline data from this Phase 3 clinical trial by early 2020.
About Chiasma
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 September 2017, the Company initiated CHIASMA OPTIMAL, its third Phase 3 clinical trial for its investigational 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 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.
Forward-Looking Statements
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 trade-named MYCAPSSA, for the maintenance 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 MPOWEREDTM Phase 3 clinical trial, the Company’s ability to randomize at least 80 patients who are responders to octreotide capsules in the MPOWERED 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 in the fourth quarter of 2019 and the Company’s ability to release top-line data from the MPOWEREDTM trial by early 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, 2017 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.
Contact:
Ashley R. Robinson
LifeSci Advisors, LLC
617-535-7742
arr@lifesciadvisors.com
