Chiasma Announces Poster Presentation at ENDO 2018 on Study Design of Phase 3 Double-Blind Trial Evaluating Oral Octreotide Capsules Versus Placebo in Patients with Acromegaly
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.
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"
For more information on Chiasma’s poster presentation at
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
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
Sharon Merrill Associates