WALTHAM, Mass., March 16, 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 of the CHIASMA OPTIMAL (Octreotide capsules vs. Placebo Treatment In MultinationAL centers) Phase 3 clinical trial design at ENDO 2018: The Endocrine Society’s 100th Annual Meeting & Expo at 1 p.m. CT on March 18, 2018 at McCormick Place in Chicago.
The presentation will describe the design of a Phase 3, randomized, double-blind, placebo-controlled, multicenter study to evaluate the efficacy and safety of oral octreotide capsules (OOC) in patients who previously tolerated and demonstrated biochemical control on injectable somatostatin receptor ligands (SRL) treatment.
“ENDO is a great opportunity to educate the scientific community about Chiasma and our most recent efforts to potentially improve the lives of patients who face challenges associated with their existing treatments for acromegaly,” said Dr. Bill Ludlam, senior vice president, clinical development and medical affairs for Chiasma. “CHIASMA OPTIMAL is a Phase 3 clinical trial for the company’s octreotide capsules product candidate, conditionally trade-named MYCAPSSA, for the maintenance therapy of adult patients with acromegaly. The trial design has also been agreed to by FDA under Special Protocol Assessment procedures. If approved, MYCAPSSA would be the first oral somatostatin analog in an injectable-only acromegaly treatment market.”
Details for the poster presentation are:
Title: "CHIASMA OPTIMAL: Study Design of a Phase 3 Double Blind Trial Evaluating Oral Octreotide Capsules Versus Placebo in Patients with Acromegaly"
Time: 1-3 p.m. CT
Date: Sunday, March 18, 2018
Location: McCormick Place, West Building, Expo Hall F, Chicago, Illinois
For more information on Chiasma’s poster presentation at ENDO 2018, please visit: http://www.abstractsonline.com/pp8/#!/4482/presentation/7909.
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. However, previous data suggest that pituitary tumors may be more prevalent than previously thought, and that the global prevalence of acromegaly may be higher, between 85 and 118 cases per million people. National Institutes of Health (NIH) also cites an annual incidence of three to four new cases per million each year. 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, which destroys 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.
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.
Sharon Merrill Associates