Summary: Beacon Biosignals and Skye Bioscience are partnering to integrate sleep quality and sleep apnea endpoints in a phase 2 trial of obesity drug candidate Nimacimab. The trial will utilize sleep monitoring technology to provide an assessment of the drug’s impact on sleep-related conditions.
Key Takeaways:
- Partnership for Comprehensive Assessment: Beacon Biosignals and Skye Bioscience are collaborating to track sleep quality and sleep apnea endpoints in the phase 2 trial of Nimacimab, aiming to understand its impact on both metabolic health and sleep-related conditions.
- Sleep Monitoring Technology: The trial will utilize the FDA-cleared Dreem 3S EEG device and Beacon’s AI-powered analytics platform to collect clinically validated sleep assessments from patients at home.
- Potential Therapeutic Benefits: By evaluating improvements in sleep patterns and apnea events, the trial seeks to establish a comprehensive view of Nimacimab’s therapeutic benefits for obesity and related comorbidities like obstructive sleep apnea.
At-home sleep monitoring and computational neurodiagnostics provider Beacon Biosignals is partnering with Skye Bioscience Inc, a pharmaceutical company developing new metabolic health treatments, to incorporate sleep quality and sleep apnea endpoints in the phase 2 trial of Nimacimab for obesity, aiming to provide a view of the drug’s impact on sleep-related conditions.
This partnership will incorporate sleep quality and sleep apnea endpoints via the Beacon Platform and the US Food and Drug Administration 510(k)-cleared Dreem 3S EEG device to better understand the impact of Nimacimab on patients with obesity.
Nimacimab, a negative allosteric-modulating antibody that inhibits the peripheral cannabinoid 1 (CB1) receptor, is currently being investigated for its potential to address obesity and cardiometabolic disease. Obstructive sleep apnea is an important comorbidity associated with obesity, with apneic events and intermittent hypoxia driving sympathetic activation and fragmented sleep with nocturnal awakenings.
Integrating Sleep Monitoring Technology
The addition of quantitative sleep-related endpoints aims to establish a comprehensive view of the therapeutic benefits of Nimacimab, given the linkage between metabolic conditions, disturbed sleep, and neurocognitive function. By integrating Beacon’s sleep monitoring technology platform, the planned phase 2 trial will assess and quantify improvements in sleep patterns and apnea events, such as sleep efficiency and the apnea-hypopnea index (AHI).
“We are thrilled to collaborate with Skye Bioscience to bring our expertise in sleep monitoring and analysis to this important clinical trial,” says Jacob Donoghue, MD, PhD, CEO of Beacon Biosignals, in a release. “Our FDA-cleared Dreem 3S EEG headband and AI-powered analytics platform will enable the collection of clinically validated sleep assessments from patients in their own homes. This will provide valuable insights into how Nimacimab may improve sleep quality and reduce sleep apnea, conditions often comorbid with obesity and cardiometabolic disease.”
Addressing Complexities of Obesity
Punit Dhillon, CEO of Skye Bioscience, adds in a release, “Understanding the multifaceted impact of Nimacimab on our target patient population is crucial because there is a growing list of diseases that have demonstrated benefit from effective treatment of obesity, including obstructive sleep apnea. Collaborating with Beacon Biosignals allows us to leverage their cutting-edge technology to monitor sleep quality and apnea, providing a more comprehensive assessment of Nimacimab’s therapeutic potential early in the drug’s development. This collaboration represents a significant step in our commitment to addressing the complexities of obesity.”
Donoghue adds in a release, “There is tremendous unmet patient need for those with obstructive sleep apnea. Next-generation weight loss therapies hold the promise to catalyze new, patient-centric clinical paradigms that can impact millions of people.”
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