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|Chiasma to Present on New Methodologies in Acromegaly Clinical Trial Design at 12th Acromegaly Consensus Conference|
Pharmacologic treatment of acromegaly includes chronic therapy with parenteral Somatostatin Receptor Ligands (SRLs), including octreotide. Chiasma is evaluating an oral formulation of octreotide, conditionally trade-named MYCAPSSA® and designed for delivery of octreotide in twice-daily oral capsules, in two Phase 3 clinical trials.
“The Acromegaly Consensus Conference is a unique forum where dozens of opinion leaders will embark in an evidence-based process to generate updated consensus guidelines. Participants will include neurosurgeons and endocrinologists with extensive experience in treating acromegaly. Chiasma has been invited to inform the acromegaly community about our body of work to potentially improve the lives of patients who face challenges associated with their existing treatments for acromegaly,” said Dr. Ludlam, senior vice president, clinical development and medical affairs for Chiasma. “Our octreotide capsules product candidate is designed for the maintenance therapy of adult patients with acromegaly. If approved, MYCAPSSA would be the first oral somatostatin analog in an injectable-only acromegaly treatment market.”
The clinical program to date includes nine Phase I studies in healthy volunteers assessing PK, PD, food effects and drug-drug interactions, two studies in hepatically and renally impaired patients, a completed Phase 3 study (CH-ACM-01), and two ongoing Phase 3 studies (MPOWERED and CHIASMA OPTIMAL) in acromegaly patients who previously demonstrated biochemical control on injectable SRL treatment. In addition, the clinical development program includes an observational study to assess treatment satisfaction with injectable SRLs and a validation study for a new patient reported outcome (PRO) tool, the Acromegaly Treatment Satisfaction Questionnaire (Acro-TSQ).
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