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Skye Bioscience Provides 2025 Look Ahead and Year in Review
Expected Phase 2 obesity data in Q2 2025 and Q4 2025 will shape clinical potential and development path of distinctive CB1 inhibitor SAN DIEGO, Jan. 13, 2025
About this update from Skye Bioscience, Inc.
[{"type":"text","content":"Expected Phase 2 obesity data in Q2 2025 and Q4 2025 will shape clinical potential and development path of distinctive CB1 inhibitor\nSAN DIEGO, Jan. 13, 2025 (GLOBE NEWSWIRE) -- Skye Bioscience, Inc. (Nasdaq: SKYE) (“Skye”), a clinical-stage biopharmaceutical company developing new therapeutic pathways for metabolic health, enters 2025 positioned to announce Phase 2 data for nimacimab, a non-incretin mechanism and first-in-class, peripherally-restricted CB1 inhibitor antibody with the potential to enhance important facets of obesity treatment while achieving significant weight loss. Skye’s goal in 2025 is to achieve clinical milestones and new scientific insights related to the unique effects and metabolic mechanisms of peripheral CB1 inhibition. “The understanding of mechanisms and opportunities to best treat obesity and overweight is still early in its evolution. There is potential to offer clinicians and patients more choices to address the unmet needs of incretin therapeutics, which include unresponsiveness to these drugs, gastrointestinal adverse events, amplified lean mass loss, and the inability to adhere to a longer-term drug regimen. There is a need for alternative approaches that can more sustainably support long-term weight management and metabolic health goals,” said Punit Dhillon, President and Chief Executive Officer of Skye. “In 2024, Skye took important steps to advance peripheral CB1 inhibition as a potential addition to the obesity drug “toolbox.” We established a clear clinical development plan for nimacimab, including accelerating nimacimab’s development plans for Phase 2b. We generated data that showed the importance of highly-peripherally-restricted CB1 inhibition and nimacimab’s potential differentiation in the obesity landscape within the class of CB1 inhibition. Corporately, we enhanced the leadership expertise within our management team, board, and obesity KOLs to drive value for stakeholders, and we established a strong balance sheet to support our strategic plan.” 2025 Major Anticipated Clinical Milestones and Planned Scientific Conference Participation Anticipated Clinical Milestones CBeyond™ Phase 2 obesity trial: completion of enrollmentCBeyond™ Phase 2 obesity trial: interim data targeted for Q2 2025: 50% enrollment of planned 120 patients after 26 weeks of treatment.CBeyond™ Phase 2 obesity tria...