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Chiasma Anticipates Trial Completion in Q4 2019 and Release of Top-line MPOWERED Data by Early 2020
WALTHAM, Mass., July 25, 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 successfully enrolled 135 acromegaly patients into the six-month run-in phase of its international Phase 3 clinical trial referred to as MPOWERED (Maintenance of Acromegaly Patients with Octreotide Capsules Compared With Injections – Evaluation of REsponse Durability). This Phase 3 trial is being conducted to potentially obtain regulatory approval in the European Union of its octreotide capsules product candidate, conditionally trade-named MYCAPSSA®, for the maintenance therapy of adult patients with acromegaly.
“We are making significant progress as we seek to advance octreotide capsules as a maintenance treatment for adult patients with acromegaly. If approved, octreotide capsules will provide these patients with an oral alternative to the current standard of care, injectable somatostatin analogs,” said Mark Fitzpatrick, president and CEO of Chiasma. “Completing enrollment of 135 patients into the run-in phase of the MPOWERED Phase 3 trial provides us with confidence that a minimum of 80 MYCAPSSA responders will be randomized to the nine-month controlled phase and that we will ultimately have sufficient data to enable us to seek regulatory approval in the European Union. We now expect to complete the MPOWERED trial in Q4 2019 and release top-line data from this trial by early 2020. This timing is consistent with the plans that we have previously announced.”
The Company also recently announced that it has achieved 50% patients randomized in its CHIASMA OPTIMAL Phase 3 trial, which is being conducted in accordance with a Special Protocol Assessment previously agreed to with the FDA. This enrollment milestone is an important step toward our goal of submitting a New Drug Application with the FDA.
Octreotide capsules are an investigational new oral drug proposed for the maintenance therapy of adult patients with acromegaly. Acromegaly is most commonly caused by a benign tumor of the pituitary gland that produces excess growth hormone (GH), ultimately leading to significant health problems and early death if untreated. GH regulates multiple metabolic processes and stimulates the production of insulin-like growth factor 1 (IGF-1) in the liver, which stimulates the growth of bones and other tissues. If approved, octreotide capsules would be the first oral somatostatin analog treatment option available for acromegaly patients, where the current standard of care is somatostatin analog injections.
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 MPOWERED, is a global, randomized, open-label and active-controlled, 15-month trial. 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 top-line data from this Phase 3 clinical trial by early 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 September 2017, the Company 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 European Union by conducting the Phase 3 MPOWERED 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 randomize at least 80 patients who are responders to octreotide capsules in the MPOWERED trial, its ability to complete the trial in Q4 2019 and to release top-line data from the MPOWERED 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 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