Harmony Biosciences Presents Preclinical Data Demonstrating Significant Wake-Promoting and Cataplexy-Suppressing Effects of BP1.15205 in Narcolepsy at SLEEP 2025

BP1.15205 is a potentially best-in-class OX2R agonist being investigated in narcolepsy and other central disorders of hypersomnolence

A first-in-human study is planned to start in 2H 2025; topline clinical data is anticipated in 2026

Excerpt from the Press Release:

PLYMOUTH MEETING, Pa.–(BUSINESS WIRE)–Harmony Biosciences Holdings, Inc. (Nasdaq: HRMY) today announced the presentation of preclinical pharmacological effect data for BP1.15205, an investigational, highly potent, and potentially best-in-class orexin 2 receptor (OX2R) 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 39^th Annual Meeting of the Associated Professional Sleep Societies (APSS) “SLEEP” on Wednesday, June 11, 2025, at 10:00 AM PDT in Seattle.

“We are encouraged by the robust preclinical data being presented at SLEEP, highlighting BP1.15205 as a potentially best-in-class OX2R agonist,” said Kumar Budur, MD, MS, Chief Medical and Scientific Officer at Harmony Biosciences. “BP1.15205 is a new and unique chemical scaffold optimized for high potency that demonstrated statistically significant wake-promoting effects at very low doses administered orally in the standard transgenic mouse model. These findings are supportive of dosing flexibility to potentially treat all three central disorders of hypersomnolence at low doses, which could offer an optimized benefit / risk profile. The 3-month GLP toxicity study in two species revealed no concerning adverse events and supports a favorable safety and tolerability profile.”

Click the button below to read the entire Press Release:

Continue Reading The Press Release