Beacon Biosignals Announces Strategic Collaboration with Skye Bioscience to Integrate Sleep Quality and Sleep Apnea Endpoints in CBEYOND™ Phase 2 Trial of Nimacimab for Obesity

Beacon Biosignals, a leader in at-home sleep monitoring and computational neurodiagnostics, today announced a strategic collaboration with Skye Bioscience, Inc. (Nasdaq: SKYE), a pharmaceutical company focused on unlocking new therapeutic pathways for metabolic health, to enhance its upcoming CBEYOND™ Phase 2 clinical trial of Nimacimab. This partnership will incorporate sleep quality and sleep apnea endpoints via the Beacon Platform and the FDA 510(k)-cleared Dreem 3S EEG device to better understand the comprehensive 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.

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 advanced 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," said Jacob Donoghue, MD, PhD, CEO of Beacon Biosignals. "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."

"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," said Punit Dhillon, CEO of Skye Bioscience. "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."

Obstructive sleep apnea affects up to 40 million Americans, with an estimated 82-93% of individuals remaining undiagnosed. Of those treated, up to 38% of patients are not adherent to traditional continuous positive airway pressure (CPAP) therapy (Rotenberg et al., 2016). Donoghue added, "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."

References

André, S., Andreozzi, F., Van Overstraeten, C. et al. Cardiometabolic comorbidities in obstructive sleep apnea patients are related to disease severity, nocturnal hypoxemia, and decreased sleep quality. Respir Res 21, 35 (2020).

Rotenberg BW, Murariu D, Pang KP. Trends in CPAP adherence over twenty years of data collection: a flattened curve. J Otolaryngol Head Neck Surg. 2016 Aug 19;45(1):43.

About Beacon Biosignals

Beacon Biosignals is the leading at-home EEG platform for precision drug development. Its FDA 510(k)-cleared Dreem 3S EEG headband algorithms enable and accelerate research and development of treatments that transform the lives of patients with neurological, psychiatric, and sleep disorders. Beacon’s Clinico-EEG database contains over 100,000 patients’ brain activity data, and its cloud-native analytics platform empowers rapid interrogation of brain activity to support retrospective and prospective studies. For more information, visit [beacon.bio](https://www.beacon.bio).

About Skye Bioscience

Skye is focused on unlocking new therapeutic pathways for metabolic health. Backed by specialist life science investors, Skye's strategy leverages biologic targets with substantial human proof of mechanism for the development of first-in-class therapeutics with clinical and commercial differentiation. Skye plans to start a Phase 2 clinical trial in obesity in Q3 2024 for Nimacimab, a negative allosteric modulating antibody that peripherally inhibits CB1, comparing monotherapy and combination arms of Nimacimab and a GLP-1R agonist. For more information, please visit: https://www.skyebioscience.com.

For Beacon Biosignals media inquiries, please contact:

Dan FloreyBeacon BiosignalsEmail: [e-mail]: https://x.com/BiosignalsLinkedIn: https://www.linkedin.com/company/beacon-biosignals

A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/4457a080-bc24-4006-b2b8-395a3454f4ce