Business
Skye Bioscience Reports Second Quarter 2024 Financial Results and Recent Highlights
Advancement of clinical and regulatory steps enable the expected initiation of Phase 2 obesity clinical trial for nimacimab peripheral CB1 inhibitor in Q3
About this update from Skye Bioscience, Inc.
[{"type":"text","content":"Advancement of clinical and regulatory steps enable the expected initiation of Phase 2 obesity clinical trial for nimacimab peripheral CB1 inhibitor in Q3 2024\nSAN DIEGO, Aug. 09, 2024 (GLOBE NEWSWIRE) -- Skye Bioscience, Inc. (NASDAQ: SKYE) (“Skye” or the “Company”), a clinical-stage biopharmaceutical company focused on unlocking new therapeutic pathways for metabolic health, today reported financial results for the second quarter ended June 30, 2024, and highlighted recent corporate achievements. “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,” said Punit Dhillon, CEO of Skye. “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. During the second quarter of 2024, we made changes to further support our metabolic focus by adding expertise to our Board of Directors and forming a clinical and scientific advisory board with key opinion leaders. We believe that our uplisting to NASDAQ and strong cash position provide us with the foundation to efficiently execute our Phase 2 obesity clinical trial and build on our strategic vision.” Key Corporate and Clinical Program Highlights Phase 2 Trial in Obesity Expected to Begin in Q3 2024 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 (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...