PLYMOUTH MEETING, PA — Harmony Biosciences Holdings, Inc. (Nasdaq: HRMY) has begun dosing participants in a Phase 1 clinical study of BP1.15205, a next-generation orexin 2 receptor agonist positioned as a potential once-daily treatment for narcolepsy, idiopathic hypersomnia and related sleep-wake disorders.
The early-stage trial, conducted by Bioprojet Pharma in the European Union, will evaluate the investigational therapy’s safety, tolerability, pharmacokinetics and pharmacodynamics across single and multiple ascending doses in healthy volunteers and sleep-deprived adults. Harmony said topline data are anticipated in 2026.
Executives describe BP1.15205 as a highly potent and selective OX2R agonist with a differentiated chemical scaffold. Preclinical studies presented earlier this year at SLEEP 2025 and the World Sleep Congress indicated strong receptor selectivity and no meaningful off-target activity. Researchers reported no adverse events of interest and highlighted evidence supporting low-dose, once-daily administration.
Kumar Budur, MD, MS, Harmony’s chief medical and scientific officer, said the compound’s profile may offer advantages in a therapeutic landscape where combination regimens are common. He added that orexin-based therapies could expand the company’s sleep-wake portfolio alongside its existing pitolisant-focused programs.
BP1.15205 was originally licensed by Bioprojet from Teijin Pharma. Harmony holds exclusive U.S. and Latin American rights under a development, manufacturing and commercialization agreement with Bioprojet.
Narcolepsy affects roughly 170,000 Americans and is marked by excessive daytime sleepiness, cataplexy, and other symptoms of REM sleep dysregulation. Idiopathic hypersomnia presents with persistent, unrelenting daytime sleepiness despite adequate sleep time, often accompanied by prolonged morning sleep inertia and cognitive slowing. Both conditions significantly impair daily function and remain challenging to diagnose and treat.
Harmony’s latest move signals a deeper push into orexin-targeted medicine, an area drawing increasing industry attention as companies race to develop more precise and durable therapies for sleep-wake instability disorders.
For the latest news on everything happening in Chester County and the surrounding area, be sure to follow MyChesCo on Google News and MSN.