Beacon Biosignals Partners with Harmony Biosciences to Integrate AI-Driven EEG Technology in Phase 3 Hypersomnia Trials
Key Insights
Beacon Biosignals announced a collaboration with Harmony Biosciences to incorporate quantitative EEG measurements into two Phase 3 studies of HBS-301 for narcolepsy and idiopathic hypersomnia.
The partnership will use Beacon's FDA 510(k)-cleared Waveband EEG headband to capture objective sleep data alongside traditional patient-reported outcomes like the Epworth Sleepiness Scale.
The collaboration aims to enhance precision in evaluating treatment outcomes for hypersomnia disorders by providing continuous monitoring of both nighttime sleep quality and daytime sleepiness patterns.
Beacon BiosignalsSearch company, a leader in AI-driven neurophysiology and precision drug development, announced a collaboration with Harmony BiosciencesView company profile to incorporate quantitative electroencephalography (EEG) measurements into two Phase 3 studies of HBS-301Search drug for narcolepsySearch disease and idiopathic hypersomniaSearch disease. The partnership aims to complement traditional patient-reported outcomes with objective sleep EEG data to assess excessive daytime sleepinessSearch disease (EDS).
Advanced EEG Technology Integration
The collaboration will utilize Beacon's FDA 510(k)-cleared Waveband EEG headband and AI-driven algorithms to capture at-home brain data across consecutive nights of sleep. The wireless, low-profile design enables continuous EEG monitoring to assess both nighttime sleep quality and daytime naps, providing a more precise view of hypersomnolence in real-world environments.
"This collaboration with Harmony represents an important step toward bringing quantitative sleep neurophysiology into late-stage drug development," said David Matthews, PhD, President of Life Sciences at Beacon BiosignalsSearch company. "Measuring objective sleep EEG data alongside subjective endpoints like patient-reported outcomes improves the precision and interpretability of treatment outcomes, and we expect it will accelerate the path toward better therapies for people living with hypersomnia disorders."
Addressing Clinical Trial Limitations
Current trial measures for hypersomnia conditions rely heavily on subjective patient-reported scales, such as the Epworth Sleepiness Scale (ESS), which may underrepresent the true burden of disease. NarcolepsySearch disease is characterized by severe excessive daytime sleepinessSearch disease with or without cataplexySearch disease, while idiopathic hypersomniaSearch disease presents with debilitating EDS, prolonged unrefreshing naps, and severe sleep inertiaSearch disease following nighttime sleep.
The addition of quantitative EEG-based endpoints allows for more robust characterization of both daytime and nighttime sleep patterns, enabling identification of EEG biomarkers that may inform dose selection, efficacy assessment, and potential patient subgroup analysis.
Clinical Development Impact
Kumar Budur, MD, MS, Chief Medical and Scientific Officer at Harmony BiosciencesView company profile, emphasized the collaboration's significance: "By integrating Beacon's innovative EEG platform into our HBS-301Search drug Phase 3 studies, we aim to bring new levels of objectivity and reliability to clinical endpoints in hypersomnia disorders, enhancing our ability to evaluate treatment benefit and better serve the patient community."
The partnership reinforces both organizations' shared mission to advance precision medicine in sleep disorders using cutting-edge neurotechnology and clinical research innovation. Harmony BiosciencesView company profile is a commercial-stage pharmaceutical company with an FDA-approved treatment for narcolepsySearch disease and a pipeline focused on advancing therapies for sleep/wake, epilepsy, and other rare neurological disorders.