Summary: Skye Bioscience Inc, a clinical-stage biopharmaceutical company, reported its second-quarter results, emphasizing the upcoming phase 2 trial of nimacimab, a treatment for obesity that will also explore the impact of weight loss on sleep quality using Beacon Biosignal’s Dreem Headband. The company has made strategic moves, including the acquisition of nimacimab, the appointment of new board members, and the formation of a clinical and scientific advisory board, to strengthen its focus on metabolic health and sleep research.
Key Takeaways:
- Phase 2 Obesity Trial: Skye Bioscience is set to begin a phase 2 clinical trial of nimacimab for obesity, which will include an exploratory arm to assess the effects of weight loss on sleep quality.
- Sleep Quality Focus: The trial will utilize Beacon Biosignal’s Dreem Headband to monitor sleep quality in a subset of patients, highlighting the link between obesity treatments and improved sleep health.
- Strategic Expansion: Skye Bioscience has strengthened its focus on metabolic health by acquiring nimacimab, expanding its board of directors, and forming a clinical and scientific advisory board with key opinion leaders.
Skye Bioscience Inc, a clinical-stage biopharmaceutical company, reported its second-quarter results, highlighting key developments including the upcoming phase 2 trial of nimacimab for obesity, which will incorporate sleep quality assessments using Beacon Biosignal’s Dreem headband to explore the impact of weight loss treatments on sleep health.
“Our strategic acquisition of nimacimab in August 2023 has propelled Skye into the metabolic landscape, where there is a need to provide patients with obesity more tolerable and sustainable therapeutic alternatives to manage weight loss and address comorbid conditions,” says Punit Dhillon, CEO of Skye, in a release. “In Q2, at our event, ‘Metabolic Rewiring with CB1 Inhibition,’ we outlined our CBeyond phase 2 clinical trial design and highlighted nimacimab’s differentiators, which we believe competitively position Skye.
Key Corporate and Clinical Program Highlights
Phase 2 Trial in Obesity Expected to Begin in Q3
Nimacimab is a first-in-class humanized monoclonal antibody that acts as a negative allosteric modulator to inhibit CB1 signaling in the periphery.
- 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, and changes in key metabolic biomarkers such as triglycerides, insulin, and leptin sensitivity.
- This trial will also 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 people, Skye’s CBeyond trial will use Beacon Biosignal’s US Food and Drug Administration 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.
Corporate Highlights
Skye recently announced the appointment of Karen Smith, MD, PhD, MBA, LLM, to its board of directors. Smith brings global biotech and biopharma leadership expertise to Skye, including over 10 years of board and advisory experience.
Additionally, Skye recently announced the appointment of a new clinical and scientific advisory board to support the development of nimacimab, with advisors including Lee Kaplan, MD, PhD, Louis Aronne, MD, Rekha Kumar, MD, MS, Marcus DaSilva Goncalves, MD, PhD, Beverly Tchang, MD, Eduardo Muñoz, MD, PhD, and Giovanni Appendino, PhD.
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