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Harmony Biosciences to Present New Open-Label Extension Data from Phase 3 ARGUS Trial at the 2025 American Epilepsy Society Annual Meeting
PLYMOUTH MEETING, Pa.--(BUSINESS WIRE)-- Harmony Biosciences Holdings, Inc. (Nasdaq: HRMY), today announced that it will highlight new open-label extension
About this update from Harmony Biosciences Holdings, Inc.
[{"type":"text","content":" PLYMOUTH MEETING, Pa.--(BUSINESS WIRE)--\nHarmony Biosciences Holdings, Inc. (Nasdaq: HRMY), today announced that it will highlight new open-label extension data from the company’s investigation of EPX-100 (clemizole hydrochloride) in the ongoing Phase 3 ARGUS trial for the treatment of Dravet syndrome at the 2025 American Epilepsy Society (AES) Annual Meeting being held December 5 – December 9, 2025, in Atlanta, GA.\n\nThe ARGUS trial is currently enrolling, and more information can be found at argustrial.com.\n\nThe posters will be on display on Monday, December 8, from 8:00 am - 2:00 pm ET. Poster presentation details are listed below:\n\n\nAbstract Title:\n\n\nEPX-100 as Adjunctive Therapy in Patients With Dravet Syndrome: Preliminary Results From the Open-Label Extension Phase of the ARGUS Study\n\n\n\n\nPoster #:\n\n\n3.353\n\n\n\n\n\nPresentation:\n\n\n\n\nMonday, December 8, from 12:00 pm – 1:45 pm ET\n\n\n\n\n\n\n\n \n\n\n\n\n\nAbstract Title:\n\n\n\n\nA Drug-Drug Interaction Study of EPX-100 (Clemizole Hydrochloride) With Clinical Probe Substrates for Selected CYP Enzymes\n\n\n\n\n\nPoster #:\n\n\n\n\n3.359\n\n\n\n\n\nPresentation:\n\n\n\n\nMonday, December 8, from 12:00 pm – 1:45 pm ET\n\n\n\n\nAbout Clemizole Hydrochloride (EPX-100)\nEPX-100, clemizole hydrochloride, is an investigational product under development for the treatment of Dravet syndrome (DS) and Lennox-Gastaut syndrome (LGS). EPX-100 acts by targeting central 5-hydroxytryptamine 2 (5HT-2) receptors to modulate serotonin signaling. EPX-100 is administered orally twice a day in a liquid formulation and has been developed based on a proprietary phenotype-based zebrafish drug screening platform. These scn1Lab mutant zebrafish replicate the genetic etiology and phenotype observed in the majority of individuals with DS. The scn1Lab mutant zebrafish model that expresses voltage gated sodium channels has been used for high-throughput screening of compounds that modulate Nav1.1 in the central nervous system.\n\nAbout Dravet Syndrome\nDravet syndrome (DS) is a severe and progressive developmental epileptic encephalopathy that causes significant impact on patient functioning. DS begins in the first year of life and is characterized by high seizure frequency and severity, intellectual disability, and an increased risk of sudden unexpected death in epilepsy (SUDEP)...