Skye Bioscience, Inc. treated the first patient in the Part C expansion of its CBeyond Phase 2a obesity trial on April 2 2026. The expansion evaluates the safety and pharmacokinetics of two higher‑dose intravenous regimens—400 mg and 600 mg—administered over 16 weeks with a 12‑week follow‑up.
The study will enroll eight participants per cohort, randomized 3:1 to nimacimab or placebo. Enrollment in the 600 mg cohort will proceed only after a favorable safety review of the first four weeks of the 400 mg cohort by an independent review committee.
This milestone is a key step toward informing the Phase 2b dose‑range study. Exposure‑response data at doses projected to achieve 700 mg and 1,000 mg subcutaneous equivalents will help confirm that higher peripheral tissue exposure can enhance efficacy while maintaining the antibody’s peripheral‑restriction safety profile. The data will shape the design and timing of the next clinical phase and support the company’s funding strategy as it approaches its Q4 2026 runway deadline.
Prior Phase 2a results showed that the 200 mg monotherapy dose failed to meet its primary weight‑loss endpoint, likely due to suboptimal drug exposure. The higher IV doses in Part C are intended to overcome this limitation. Nimacimab is positioned as an orthogonal add‑on therapy to GLP‑1 agents, offering additive weight loss without the central nervous system side effects associated with earlier CB1 inhibitors.
Punit Dhillon, President and CEO, said the data generated over the past year have sharpened the company’s understanding of nimacimab’s dose‑response relationship and strengthened the case for higher‑exposure evaluation. He added that the company’s objective is to focus nimacimab where an orthogonal mechanism can be most differentiated, particularly in patients already treated with GLP‑1 who still need more weight loss.
Skye’s cash position of $25.7 million as of December 31 2025 is expected to fund operations through Q4 2026, but the company remains mindful of future funding needs for the upcoming Phase 2b study. The collaboration with Halozyme to develop a high‑volume subcutaneous co‑formulation will facilitate easier administration in the planned Phase 2b trial. Investors are cautious about the pace of clinical development and the timing of future funding rounds, reflecting the company’s current financial runway and the need for additional capital to advance the program.
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