Skye Bioscience Reports Phase 2a Data: Nimacimab Monotherapy Misses Endpoint, Combination Shows Added Weight Loss

Skye Bioscience, Inc.

Nimacimab monotherapy at 200 mg failed primary endpoint with placebo-subtracted weight loss of -1.26% (p=0.2699, mITT).
Combination of nimacimab + semaglutide achieved -13.2% weight loss vs -10.25% for semaglutide alone (-2.95%, p=0.0372, mITT).
In per protocol analysis, 100% of combination arm achieved >5% weight loss and 67% achieved >10% weight loss.
No increase in gastrointestinal or neuropsychiatric adverse events with nimacimab, and clean safety profile reported.
Preliminary PK showed lower than expected exposure, supporting evaluation of higher dosing in future trials.

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