Harmony Biosciences presents preclinical data for BP1.15205

Harmony Biosciences (HRMY) announced the presentation of preclinical pharmacological effect data for BP1.15205, an investigational, highly potent, and orexin 2 receptor agonist, which demonstrated significant wake-promoting and cataplexy-suppressing effects in a standard transgenic mouse model of narcolepsy type 1. The data will be presented at the 39th Annual Meeting of the Associated Professional Sleep Societies on Wednesday, June 11. Orexin receptor functional studies showed that BP1.15205 is a highly potent, selective OX2R receptor agonist with no off-target effects expected and a greater than 600-fold selectivity over human OX1R. BP1.15205 is orally bioavailable and has the potential for once-daily dosing. Absorption, distribution, metabolism, and excretion properties and preliminary toxicology studies showed that BP1.15205 is a differentiated OX2R agonist drug candidate. In the GLP toxicity study, no adverse events or biochemical changes were observed following a three-month treatment period at doses up to 300 mg/kg/day, pending histopathology data. An Investigational Medicinal Product Dossier application with the European Medicines Agency is being completed for BP1.15205. A first-in-human study is planned to begin in 2H 2025 with topline data anticipated in 2026. Additionally, an Investigational New Drug application for BP1.15205 will be filed with the FDA. BP1.15205 is highly selective for human OX2R receptors: greater than600-fold selectivity over human OX1R receptors. Minimal interspecies difference in agonist functional properties was observed between human and mouse orexin-2 receptors. Single oral dose administration of BP1.15205 in transgenic mice at the beginning of the 12-hour dark period of a 24-hour light/dark cycle produced significant and dose-dependent increases in total wakefulness time and sleep latency at every dose tested beginning at 0.03 and 0.1 mg/kg, respectfully, as compared to vehicle-treated animals. Significant and dose-dependent decreases in the total number and duration of cataplexy-like episodes were measured following single dose, oral administration of BP1.15205 beginning at 1mg/kg, as compared to vehicle.