Harmony Biosciences Holdings, Inc. has begun dosing the first participant in a Phase 1 clinical trial of its investigational orexin‑2 receptor agonist BP1.15205, marking the first human exposure of the compound.
The study, conducted by Bioprojet Pharma in the European Union, will assess safety, tolerability, pharmacokinetics and pharmacodynamics in healthy volunteers and sleep‑deprived subjects, and will provide the first data on the drug’s once‑daily dosing potential.
BP1.15205 expands Harmony’s sleep‑wake portfolio beyond its flagship pitolisant product, WAKIX®, by targeting narcolepsy, idiopathic hypersomnia and other central disorders of hypersomnolence. A successful Phase 1 program could open a new revenue stream and complement the existing pitolisant franchise.
The compound was originally licensed from Teijin Pharma to Bioprojet, and Harmony holds an exclusive U.S. and Latin‑American license. The partnership underscores Harmony’s strategy to diversify its pipeline and reduce reliance on a single product.
Dr. Kumar Budur, Chief Medical and Scientific Officer, said the preclinical data demonstrate high potency, selectivity and a favorable safety profile, and that once‑daily dosing could translate into a favorable risk‑benefit profile for patients with central disorders of hypersomnolence.
Harmony’s WAKIX® continues to generate strong revenue, with Q3 2025 net revenue of $239.5 million, a 29% year‑over‑year increase, and a healthy cash position that supports ongoing R&D investments. The Phase 1 milestone positions the company for future Phase 2 studies and potential revenue diversification.
No immediate market reaction data are available, but such milestones typically influence investor sentiment over time as clinical data become available.
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