PLYMOUTH MEETING, PA — Harmony Biosciences recently revealed compelling preclinical data for BP1.15205, a highly potent and selective orexin 2 receptor (OX2R) agonist, at the 39th Annual Meeting of the Associated Professional Sleep Societies (APSS) in Seattle. This investigative therapy demonstrates significant potential to address narcolepsy type 1 and other central disorders of hypersomnolence, marking a major advancement in the field of sleep medicine.
The data underscores BP1.15205’s robust wake-promoting and cataplexy-suppressing properties, observed in a standard transgenic mouse model of narcolepsy. The compound, designed as an oral treatment, showcases remarkable potency, with statistically significant effects at minimal doses, which could lead to substantial dosing flexibility and an optimized benefit-risk profile.
“We are encouraged by the robust preclinical data being presented at SLEEP, highlighting BP1.15205 as a potentially best-in-class OX2R agonist,” said Dr. Kumar Budur, Chief Medical and Scientific Officer at Harmony Biosciences. “These findings support dosing flexibility to potentially treat all three central disorders of hypersomnolence at low doses, which could offer an optimized benefit/risk profile.”
Key study outcomes highlighted BP1.15205’s exceptional selectivity for OX2R over other receptor targets, with a >600-fold preference for human OX2R versus OX1R. Preclinical in vivo evaluations demonstrated dose-dependent increases in wakefulness and reductions in cataplexy-like episodes, confirming BP1.15205’s strong pharmacological promise.
The compound also showed favorable absorption, distribution, metabolism, and excretion (ADME) characteristics, with no adverse effects observed during a three-month toxicology study at doses up to 300 mg/kg/day in two species.
Path to Clinical Development
Harmony Biosciences is moving forward with plans to initiate human trials for BP1.15205. An Investigational Medicinal Product Dossier (IMPD) application is currently being prepared for submission to the European Medicines Agency, with a first-in-human study scheduled to begin in the second half of 2025. Topline data is expected in 2026. Additionally, the company plans to file an Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA).
Beyond its potential to redefine the treatment landscape for narcolepsy, BP1.15205 aims to address a broader range of central disorders of hypersomnolence, potentially improving outcomes for patients globally.
“We are very excited to advance our potentially best-in-class OX2R program and support the strategic expansion of our sleep-wake franchise,” Dr. Budur added. “We are dedicated to investigating this potential new solution further with the hope of bringing a novel treatment to market that can help even more people with narcolepsy and other central disorders of hypersomnolence.”
Narcolepsy and Advancing Treatment Options
Narcolepsy is a chronic neurological disorder affecting approximately 170,000 Americans. Hallmarked by excessive daytime sleepiness and cataplexy, it results from the loss of orexin, a neuropeptide critical to sleep-wake state stability. With a typical onset in adolescence or young adulthood, narcolepsy remains significantly underdiagnosed, often taking up to 10 years for proper identification.
Harmony Biosciences’ pioneering efforts with BP1.15205 reflect a commitment to honing innovative treatments and advancing the care of individuals with narcolepsy and related conditions.
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