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Beacon Biosignals, a leader in AI-driven neurophysiology and precision drug development, today announced a collaboration with Harmony Biosciences (Nasdaq: HRMY), a pharmaceutical company dedicated to developing and commercializing innovative therapies for rare neurological disorders, to incorporate quantitative electroencephalography (EEG) measurements into two of Harmony's Phase 3 studies of HBS-301 for Narcolepsy and Idiopathic Hypersomnia.
The collaboration will support Harmony's primary objective of assessing excessive daytime sleepiness (EDS) by complementing traditional patient-reported outcomes, such as the Epworth Sleepiness Scale (ESS), with objective sleep EEG data.
Through this study, Beacon's FDA 510(k)-cleared Waveband EEG headband and AI-driven algorithms will be used to capture at-home brain data across consecutive nights of sleep. Additionally, it will assess daytime sleepiness with continuous EEG data enabled by the Waveband's wireless, low-profile design. By continuously measuring nighttime sleep quality as well as daytime naps, Beacon's technology provides 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 Biosignals. "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."
"Harmony Biosciences is committed to advancing scientific understanding and treatment of central disorders of hypersomnolence," said Kumar Budur, MD, MS, Chief Medical and Scientific Officer at Harmony Biosciences. "By integrating Beacon's innovative EEG platform into our HBS-301 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."
Narcolepsy is characterized by severe excessive daytime sleepiness with or without cataplexy, while Idiopathic Hypersomnia is characterized by debilitating EDS, prolonged unrefreshing naps, and severe sleep inertia following nighttime sleep. Current trial measures rely heavily on subjective patient-reported scales, which may underrepresent the true burden of disease. 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.
The collaboration reinforces both organizations' shared mission to advance precision medicine in sleep disorders using cutting-edge neurotechnology and clinical research innovation.
About Beacon Biosignals
Beacon Biosignals is unlocking the power of brain data to advance human health. The company combines FDA-cleared wearable EEG technology with advanced AI to capture and analyze real-world neural data, enabling breakthroughs across neurology, psychiatry, and sleep medicine. The Beacon Platform provides clinicians and biopharma partners with objective measures of brain function that accelerate research, improve diagnostics, and guide new treatments. Learn more at www.beacon.bio .
About Harmony Biosciences
Harmony Biosciences (Nasdaq: HRMY) is a commercial-stage pharmaceutical company dedicated to developing and delivering innovative therapies to patients living with rare neurological disorders. Harmony's portfolio includes FDA-approved treatment for narcolepsy and a pipeline focused on advancing therapies for sleep/wake, epilepsy and other rare neurological disorders. Learn more at www.harmonybiosciences.com .
Media Contact:
Isabella Lazzareschi, Beacon Biosignals
Isabella.lazzareschi@beacon.bio
