Core Insights - Beacon Biosignals and Harmony Biosciences have announced a collaboration to integrate quantitative EEG measurements into Harmony's Phase 3 studies for HBS-301 targeting Narcolepsy and Idiopathic Hypersomnia [1][2] Group 1: Collaboration Details - The collaboration aims to enhance the assessment of excessive daytime sleepiness (EDS) by incorporating objective EEG data alongside traditional patient-reported outcomes like the Epworth Sleepiness Scale (ESS) [2] - Beacon's FDA 510(k)-cleared Waveband EEG headband will be utilized to capture at-home brain data over consecutive nights, providing continuous EEG data to assess daytime sleepiness [3] Group 2: Objectives and Benefits - The integration of objective sleep EEG data is expected to improve the precision and interpretability of treatment outcomes, potentially accelerating the development of better therapies for hypersomnia disorders [4] - The collaboration seeks to bring new levels of objectivity and reliability to clinical endpoints, enhancing the evaluation of treatment benefits for patients with hypersomnia disorders [4] Group 3: Clinical Context - Narcolepsy and Idiopathic Hypersomnia are characterized by severe excessive daytime sleepiness, with current trial measures relying heavily on subjective patient-reported scales, which may not fully capture the disease burden [4] - The addition of quantitative EEG-based endpoints allows for a more robust characterization of sleep patterns, aiding in the identification of EEG biomarkers for dose selection and efficacy assessment [4] Group 4: Company Profiles - Beacon Biosignals specializes in AI-driven neurophysiology and precision drug development, utilizing wearable EEG technology to capture and analyze neural data for advancements in neurology and sleep medicine [6] - Harmony Biosciences focuses on developing innovative therapies for rare neurological disorders, with a portfolio that includes FDA-approved treatments for narcolepsy and a pipeline targeting sleep/wake disorders and epilepsy [7]