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HARMONY BIOSCIENCES TO PRESENT RESULTS FROM BEHAVIORAL STUDY IN 22Q11.2 DELETION SYNDROME AT AMERICAN COLLEGE OF NEUROPSYCHOPHARMACOLOGY ANNUAL MEETING
Qualitative interview study informs future clinical trial endpoints for evaluating ZYN002 PLYMOUTH MEETING, Pa., Dec. 5, 2023 /PRNewswire/ -- Harmony
About this update from Harmony Biosciences Holdings, Inc.
[{"type":"text","content":"Qualitative interview study informs future clinical trial endpoints for evaluating ZYN002\n\n\nPLYMOUTH MEETING, Pa., Dec. 5, 2023 /PRNewswire/ -- Harmony Biosciences Holdings, Inc. (\"Harmony\" or the \"Company\") (Nasdaq: HRMY), a pharmaceutical company dedicated to developing and commercializing innovative therapies for patients with rare neurological diseases, will present caregiver-reported impacts of 22q11.2 deletion syndrome (22q) and data from the Phase 2 INSPIRE trial at the American College of Neuropsychopharmacology Annual Meeting from December 3-6, 2023.\n\n \n \n \n \n \n \n\n \nThe INSPIRE trial evaluated ZYN002 as a potential treatment for anxiety and other irritable behavioral symptoms associated with 22q. Qualitative behavioral analyses of patients and their caregivers, both from INSPIRE and an independent panel, as well as prospective post-hoc analyses of the INSPIRE trial, informed the creation of a conceptual framework for the selection of patient-centered assessments for future clinical trials. This framework proposes endpoint measures to assess the treatment of behavioral symptoms associated with the condition, which currently lacks FDA-approved treatments and affects approximately 80,000 individuals in the U.S. and 129,000 in the EU and UK.\n\"Harmony is dedicated to finding effective treatments for children and their families living with 22q and other rare neuropsychiatric conditions that currently lack approved therapies,\" said Kumar Budur, M.D., M.S., Chief Medical Officer at Harmony Biosciences. \"Through our recent acquisition of Zynerba, we are making meaningful strides toward developing new treatments for individuals with the behavioral symptoms associated with 22q and Fragile X syndrome (FXS). The development of endpoint measures for future clinical trials is an important step forward in our work for 22q patients who have high unmet medical needs.\"\nPoster: Anxious and Irritable Behaviors in Children with 22q11.2 Deletion Syndrome: A Qualitative Interview Study and Development of a Conceptual Framework \nPoster Session II: Tuesday, December 5, 5PM – 7PM (ET)ZYN002 is being evaluated as an investigational treatment for 22q. It is not approved for commercial distribution by government regulatory bodies, including the U.S. Food and Drug Administration (FDA).\nAbout the INSPIRE Trial The 38-week INSP...