Beacon Biosignals and Skye Bioscience Collaborate to Integrate Sleep Metrics in Phase 2 Obesity Trial of Nimacimab

Beacon Biosignals, a frontrunner in sleep monitoring and neurodiagnostics, has entered a strategic collaboration with Skye Bioscience, a pharmaceutical company, to enhance the CBEYOND™ Phase 2 clinical trial of Nimacimab. This collaboration aims to integrate sleep quality and sleep apnea endpoints using Beacon's advanced platform and the FDA-cleared Dreem 3S EEG device to fully understand Nimacimab's effects on patients with obesity.

Nimacimab, an antibody designed to inhibit the peripheral cannabinoid 1 (CB1) receptor, is being studied for its potential to address obesity and related cardiometabolic diseases. Obstructive sleep apnea, a condition prevalent among obese individuals, is associated with disrupted sleep and intermittent hypoxia, which can lead to sympathetic activation and fragmented sleep. By including sleep-related endpoints, the trial seeks to provide a comprehensive view of Nimacimab's therapeutic benefits, highlighting the connection between metabolic conditions, disturbed sleep, and neurocognitive functions.

The integration of Beacon's sleep monitoring technology will allow the Phase 2 trial to accurately measure improvements in sleep patterns and apnea events. This includes assessing sleep efficiency and the apnea-hypopnea index (AHI). Jacob Donoghue, CEO of Beacon Biosignals, expressed enthusiasm for the collaboration, emphasizing that their technology will enable the collection of clinically-validated sleep data from patients at home. This will offer valuable insights into Nimacimab's potential to improve sleep quality and reduce sleep apnea, conditions often comorbid with obesity and cardiometabolic disease.

Punit Dhillon, CEO of Skye Bioscience, highlighted the importance of understanding Nimacimab's impact on the target patient population. He noted that effective obesity treatment has shown benefits for a growing number of diseases, including obstructive sleep apnea. Dhillon pointed out that collaborating with Beacon Biosignals allows Skye to leverage cutting-edge technology to monitor sleep quality and apnea, thus providing a comprehensive assessment of Nimacimab's therapeutic potential early in its development. This collaboration underscores Skye's commitment to addressing the complexities associated with obesity.

Obstructive sleep apnea affects up to 40 million Americans, with a significant portion remaining undiagnosed. Of those receiving treatment, a considerable percentage are non-compliant with traditional CPAP therapy. Donoghue noted the unmet patient needs in this area and emphasized that next-generation weight loss therapies hold promise for creating new, patient-centric clinical paradigms that could benefit millions.

Beacon Biosignals is renowned for its at-home EEG platform which supports precision drug development. The Dreem 3S EEG headband, cleared by the FDA, and its AI-powered analytics platform, facilitate the collection and analysis of sleep data, expediting the research and development of treatments for neurological, psychiatric, and sleep disorders. The company’s extensive Clinico-EEG database and cloud-native analytics platform empower rapid analysis of brain activity, supporting both retrospective and prospective studies.

Skye Bioscience is dedicated to discovering new therapeutic pathways for metabolic health. Its strategy involves leveraging biologic targets with significant human proof of mechanism to develop first-in-class therapeutics with clinical and commercial differentiation. Skye plans to initiate a Phase 2 clinical trial for Nimacimab in obesity in the third quarter of 2024, comparing monotherapy and combination arms of Nimacimab and a GLP-1R agonist.