Beacon Biosignals said it has formed a collaboration with Harmony Biosciences to incorporate quantitative electroencephalography (EEG) endpoints into two of Harmony’s Phase 3 clinical trials of HBS‑301 for narcolepsy and idiopathic hypersomnia. The partnership is intended to complement traditional subjective measures of excessive daytime sleepiness (EDS)—such as the Epworth Sleepiness Scale—with objective EEG‑based data captured in real‑world settings.
Under the agreement, Beacon’s FDA 510(k)‑cleared Waveband EEG headband and AI‑driven algorithms will be deployed to collect continuous brain‑activity data from study participants. The technology is designed to monitor both nighttime sleep quality across consecutive nights and daytime sleep episodes via a wireless, low‑profile wearable, providing more granular physiological insight than patient‑reported scales alone. By capturing these quantitative metrics, researchers hope to better characterize patterns of hypersomnolence and identify EEG‑derived biomarkers that could inform dose selection, efficacy assessment and subgroup analyses in the clinical programmes.
Narcolepsy involves severe EDS with or without cataplexy, whereas idiopathic hypersomnia is marked by debilitating daytime sleepiness, prolonged unrefreshing naps and severe sleep inertia following sleep. Both conditions are traditionally assessed with subjective measures that may underrepresent the true burden of disease. Beacon’s objective EEG data aims to provide a more precise view of sleep and wake‑state physiology, potentially enhancing the interpretability of treatment effects in late‑stage drug development.
The collaboration reflects a broader trend of combining AI‑driven neurotechnology with pharmaceutical research to improve clinical endpoints in neurological and sleep disorders and aligns with both companies’ goals to advance precision medicine approaches for hypersomnia conditions.
