Publishes New Data Regarding Time-Weighted Average Response Rate from Initial Phase 3 Trial
Presents New Injectable Somatostatin Analog Patient Reported Outcome Data
Highlights Recently Initiated MPOWERED Trial
WALTHAM, Mass., May 23, 2016 (GLOBE NEWSWIRE) -- Chiasma, Inc. (NASDAQ:CHMA), a biopharmaceutical company developing an investigational new drug, Mycapssa™ (octreotide) capsules, for the potential maintenance therapy of adult patients with the orphan disease acromegaly, today announced its participation at two upcoming medical conferences, which will include poster presentations containing patient-reported outcomes survey data, the design of a recently initiated trial and new clinical data.
2016 American Association of Clinical Endocrinologists (AACE) Annual Scientific and Clinical Congress (May 25-29 in Orlando, Florida)
Title: A Study to Develop a Novel Patient-Reported Outcomes (PRO) Instrument to Assess Satisfaction with Acromegaly Treatment: The Acro-TSQ (Abstract #1304)
Lead author: Maria Fleseriu, MD, FACE, professor and director of NW Pituitary Center, Oregon Health & Science University, Portland, USA
Date: Saturday, May 28, 2016
Title: MPOWERED™: Study Design of a Phase 3 Head-to-Head Trial Evaluating Oral Octreotide Capsules Versus Injectable Somatostatin Analogs in Patients with Acromegaly (Abstract #938)
Lead author: Maria Fleseriu, MD, FACE, professor and director of NW Pituitary Center, Oregon Health & Science University, Portland, USA
Date: Friday, May 27, 2016
European Society of Endocrinology’s ECE 2016 (May 28-31 in Munich, Germany)
Title: Longitudinal Assessment of Response to Treatment with Oral Octreotide Capsules in Patients with Acromegaly: Post-hoc Analysis of a Phase 3 Trial
Lead author: Maria Fleseriu, MD, FACE, professor and director of NW Pituitary Center, Oregon Health & Science University, Portland, USA
Date: Monday, May 30, 2016
About Mycapssa
Mycapssa is the conditional trade name of octreotide capsules, an investigational new oral drug in development for the maintenance therapy of adult patients with acromegaly. If approved, Mycapssa may be the first oral somatostatin analog approved for acromegaly. Mycapssa has been granted orphan designation in the United States and the European Union for the potential treatment of acromegaly. Chiasma received a Complete Response Letter from the U.S. Food and Drug Administration on April 15, 2016 regarding its New Drug Application for Mycapssa. Mycapssa has not been approved for use in any jurisdiction.
About Acromegaly
Acromegaly typically develops when a benign tumor of the pituitary gland produces too much growth hormone (GH), ultimately leading to significant health problems and early death if untreated. There are an estimated 69,000 individuals with acromegaly worldwide. In 13 studies of acromegaly prevalence since 1980, an average of approximately 75 cases per million was determined, suggesting roughly 24,000 individuals with acromegaly in the United States, of which an estimated 8,000 are treated chronically with somatostatin analog injections. Because symptoms often develop slowly, diagnosis may be delayed by years or decades, making it difficult to determine the total number of people with the disease.
Common features of acromegaly are facial changes, intense headaches, joint pain, impaired vision and enlargement of the hands, feet, tongue and internal organs. Serious health conditions associated with the progression of acromegaly include type 2 diabetes, hypertension, respiratory disorders and cardiac and cerebrovascular disease.
Current treatment options include surgery to remove the pituitary tumor, radiation therapy to destroy any lingering tumor cells, and/or medical treatment in cases where these approaches are not possible or fully effective. Today's medical treatments include dopamine agonists, GH antagonists, and injectable somatostatin analogs, which are the current standard of care.
About Chiasma
Chiasma is dedicated to 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 only available as injections. The company is conducting an international Phase 3 clinical trial of octreotide capsules (conditionally trade-named “Mycapssa”) for the maintenance treatment of adult acromegaly patients to support a potential submission of a Marketing Authorization Application to the European Medicines Agency. Chiasma is headquartered in the United States with a wholly owned subsidiary in Israel. Mycapssa and TPE are trademarks of Chiasma.
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 posters planned for AACE and ECE 2016. 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. These risks and uncertainties include, but are not limited to: risks associated with the regulatory review process generally; risks associated with participating in an End of Review meeting with the FDA; risks associated with Chiasma’s Phase 3 clinical trial to support regulatory approval of Mycapssa in the E.U.; risks that prior clinical data may not be indicative of future clinical results; risks associated with obtaining, maintaining and protecting intellectual property; and the risk that octreotide capsules, if approved, will not be successfully commercialized. 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, 2016 filed with the Securities and Exchange Commission on May 12, 2016. 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.