Results
Skye Bioscience Inc.
08/09/2024 | Press release | Archived content
Q2 2024 Earnings Release
- Skye recently announced its CBeyond™ Phase 2 clinical trial design for nimacimab, for the treatment of obesity. This 120-patient trial is on track to begin screening in Q3 2024 and is expected to provide interim and topline data in Q2 and Q4 of 2025, respectively. The trial's primary endpoint is to evaluate weight loss using nimacimab compared to placebo.
- Secondary endpoints include evaluations of safety and tolerability, neuropsychiatric and cognitive evaluation, change in body composition by Dual-Energy X-ray Absorptiometry (DEXA), and changes in key metabolic biomarkers such as triglycerides, insulin and leptin sensitivity.
- This trial will also be the first to evaluate the combination of a CB1 inhibitor (nimacimab) and a GLP-1 agonist (Wegovy®) in humans in an exploratory arm which will assess the difference in weight loss, the difference in body composition and changes in sleep quality.
- In connection with the Company's CBeyond™ trial for nimacimab, Skye announced a collaboration with Beacon Biosignals. Because obesity is recognized as detrimentally affecting sleep quality in some people1, Skye's CBeyond™ trial will use Beacon Biosignal's FDA 510(k)-cleared Dreem Headband to collect sleep data and assess validated sleep endpoints in a subset of 40 patients, encompassing all arms of the trial, as an exploratory endpoint.
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