Central disorders of hypersomnolence : first human clinical trial on BP1.15205

Bioprojet, in partnership with Harmony Biosciences in the United States, has announced the launch of the first human clinical trial of BP1.15205, an orexin type 2 receptor (OX2R) agonist, aimed at treating central disorders of hypersomnolence.

BP1.15205 is a molecule that has demonstrated high potency and selectivity in preclinical studies, along with a favorable safety profile and the potential for once-daily dosing.

Initial clinical data are expected in 2026.

Bioprojet and Harmony Biosciences announced today the initiation of a phase 1 clinical trial of BP1.15205, an OX2R agonist currently under development for the treatment of narcolepsy, idiopathic hypersomnia, and other central hypersomnolence disorders.

This phase 1 trial, conducted by Bioprojet Pharma in the European Union, will evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of BP1.15205 in healthy volunteers.

Earlier this year, Bioprojet and Harmony Biosciences presented comprehensive preclinical data on the safety and efficacy of BP1.15205 at the American Congress (SLEEP 2025) and the World Sleep Congress. Pharmacological studies confirmed that BP1.15205 is a highly potent and selective OX2R agonist. These data revealed no potential adverse effects and demonstrated a favorable safety and pharmacokinetic profile.

The orexin program represents a significant expansion of our wakefulness-sleep disorder franchise. Orexin agonists could enhance our treatment portfolio alongside pitolisant, enabling us to offer additional therapeutic options tailored to the complex and individualized needs of patients with narcolepsy and other hypersomnolence disorders.

BP1.15205 is a molecule originally discovered by Teijin Pharma, for which Bioprojet has obtained exclusive development and commercialization rights. Harmony Biosciences has acquired a sublicense for the U.S. territory and has committed to co-developing this molecule with Bioprojet.