Innovative Obesity Trial by Skye and Beacon for Sleep Apnea Solutions

As Skye Bioscience begins their CBeyond phase 2 clinical trial, we delve into the rationale, methodology, and anticipated outcomes of incorporating Beacon’s cutting-edge sleep monitoring technology. This collaboration aims to explore the potential of nimacimab in treating obesity and obstructive sleep apnea (OSA), with a focus on the broader implications of this partnership. We examine how this study could transform the treatment landscape for these conditions.

Given that obesity is a major risk factor for OSA, affecting up to 40 million Americans, Skye and Beacon found an opportunity to jointly assess nimacimab’s potential to alleviate sleep disturbances in patients participating in Skye’s phase 2 clinical trial. This trial aims to include quantitative sleep-related endpoints to provide a comprehensive view of nimacimab's therapeutic benefits, considering the interconnection between metabolic issues, sleep disorders, and cognitive functions.

The trial will feature exploratory endpoints that measure sleep quality using the FDA-cleared Dreem 3S EEG headband and an AI-driven analytics platform. This setup enables the collection of clinically validated sleep data from patients in their home environments. Participants will also use an oxygen saturation ring, allowing Beacon and Skye to evaluate sleep patterns, hypoxic events, and disturbances in a 40-patient sub-study.

Skye Bioscience was motivated to include Beacon’s SleepStageML software and the Dreem Headband in their phase 2 obesity trial due to the numerous comorbidities associated with obesity, including OSA. Validating effects on comorbid conditions could enhance the drug’s approval chances by payors. Recent data showing weight loss from tirzepatide improved sleep apnea highlights the significance of assessing sleep quality. Including sleep quality assessments could offer an efficient preliminary evaluation of nimacimab’s effects on comorbid conditions alongside primary weight loss assessments. Skye aims to be a pioneer among biotech companies by evaluating OSA in a phase 2 trial for obesity treatment. The choice of Beacon’s at-home EEG platform offers convenience for patients and a thorough evaluation of nimacimab's therapeutic effects on sleep quality early in its development.

In evaluating nimacimab’s impact on sleep quality and apnea, the 40-patient subset will use Beacon’s Dreem Headband to gather sleep data and assess validated endpoints. Data will be collected on multiple nights post-screening and at intervals during the trial. This integration will enable the assessment of improvements in sleep patterns and apnea events, focusing on metrics like sleep efficiency and the apnea-hypopnea index (AHI).

Obesity, influenced by physiological, lifestyle, and environmental factors, often leads to comorbid conditions like OSA due to altered physiological processes. Addressing these issues involves reversing these underlying factors. Nimacimab, a peripherally restricted cannabinoid receptor 1 (CB1)-inhibiting antibody, impacts metabolic activity that modulates energy storage and use. It may aid patients with sleep disturbances through improved obesity treatment and management.

The trial’s quantitative sleep-related endpoints aim to provide a comprehensive view of nimacimab's therapeutic benefits, considering the link between metabolic conditions, sleep disturbances, and cognitive function. By integrating Beacon's sleep monitoring technology, the trial will assess and quantify improvements in sleep patterns and apnea events.

Skye’s broader strategy for developing obesity treatments includes understanding nimacimab's impact on their target population. Leveraging Beacon’s technology to monitor sleep quality and apnea allows for the assessment of nimacimab’s potential benefits beyond weight loss. This collaboration is part of Skye's commitment to addressing obesity complexities and developing effective treatments.

The "Metabolic Rewiring with CB1 Inhibition" event highlighted the collaboration with Beacon, providing insights into nimacimab’s CB1 inhibition mechanism and its potential for treating metabolic diseases. The phase 1 study showed nimacimab was safe and well-tolerated, with no neuropsychiatric side effects. The phase 2 study aims to assess nimacimab’s efficacy, safety, and tolerability alone and with Wegovy (semaglutide) in obesity patients, with screening expected to begin in August 2024 and data anticipated in 2025.

No challenges are expected in integrating sleep data collection with ongoing clinical research using Beacon’s technology. Beacon’s experience and their at-home technology ensure convenient data collection and seamless integration with Skye’s data management.

Preliminary feedback indicates the Dreem Headband performs well compared to lab PSG, with high-quality EEG data and good usability in home settings. It has been widely used in clinical trials and academic labs, showing its reliability in collecting sleep data.

Data from the Dreem Headband will provide insights into nimacimab's effects on sleep quality related to weight loss, helping identify patterns and optimize treatment regimens for future trials focusing on OSA.