Plymouth Meeting, Pennsylvania — November 19, 2025 — Leads & Copy — Harmony Biosciences Holdings, Inc. has initiated a Phase 1 clinical trial for BP1.15205, a drug potentially used in treating narcolepsy, idiopathic hypersomnia, and other central disorders.
The trial will evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of BP1.15205 in healthy volunteers, including those who are sleep-deprived. Topline data from the trial is anticipated in 2026.
Kumar Budur, MD, MS, Chief Medical and Scientific Officer at Harmony Biosciences, expressed enthusiasm for the drug’s clinical development, citing its “compelling preclinical risk-benefit profile.” He noted that BP1.15205’s potency could allow for low, once-daily dosing, potentially leading to a favorable risk-benefit profile for patients.
Harmony Biosciences presented preclinical safety and efficacy data for BP1.15205 earlier this year at SLEEP 2025 and the World Sleep Congress. Studies confirmed the asset is a potent and selective OX2R agonist without off-target effects, and the data showed a favorable safety and tolerability profile.
Dr. Budur emphasized the importance of the orexin program in expanding Harmony’s sleep-wake franchise, stating that orexin agonists could complement the company’s pitolisant-based assets. This would allow Harmony to offer more treatment options tailored to individual patient needs.
Bioprojet Pharma is conducting the Phase 1 clinical trial in the European Union, and originally licensed BP1.15205 from Teijin Pharma. Harmony Biosciences holds an exclusive licensing agreement with Bioprojet for the development, manufacturing, and commercialization of BP1.15205 in the U.S. and Latin America.
Narcolepsy, a rare neurological disease affecting approximately 170,000 Americans, is characterized by excessive daytime sleepiness (EDS) and cataplexy. It is often caused by a loss of hypocretin/orexin, which supports sleep-wake state stability.
Idiopathic Hypersomnia (IH) is another rare, chronic neurological disease marked by excessive daytime sleepiness (EDS) despite sufficient sleep. EDS in IH cannot be alleviated by naps or longer sleep. Symptoms include sleep inertia and impaired cognition.
Harmony Biosciences, headquartered in Plymouth Meeting, PA., focuses on developing treatments for rare neurological diseases with unmet medical needs. The company was established in 2017 by Paragon Biosciences, LLC.
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Contact:
Katelyn Barry
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Source: Harmony Biosciences
