Skye Bioscience Inc. (NASDAQ:SKYE) stock sank on Monday after the company released topline data from its 26-week Phase 2a CBeyond proof-of-concept study of nimacimab.
The nimacimab monotherapy arm did not achieve the primary endpoint of weight loss compared to placebo (-1.52% vs. -0.26 for placebo, mITT).
Preliminary pharmacokinetic analysis showed lower than expected drug exposure of nimacimab, supporting evaluation of higher dosing.
Also Read: Skye Bioscience Advances Position In Competitive Obesity Market With Promising Data
In the combination cohort, nimacimab 200 mg plus semaglutide demonstrated a clinically meaningful magnitude of weight loss compared to semaglutide alone (-13.2% vs -10.25%, p=0.0372, mITT), with no plateau being observed through Week 26.
This finding supports potential further studies to evaluate combinations of nimacimab and incretin-based therapies.
Semaglutide is an active ingredient in Novo Nordisk A/S’ (NYSE:NVO) Wegovy and Ozempic.
At the tested dose and exposure levels, nimacimab 200 mg demonstrated a favorable safety profile with placebo-like tolerability.
Combined with semaglutide, there was no increase in gastrointestinal (GI) adverse events.
There were no increases in neuropsychiatric adverse events reported resulting from treatment with nimacimab.
Skye Combination Promise
In the per-protocol analysis, 100% of the patients in the combination arm achieved >5% weight loss (vs. 85% with semaglutide), and 67% achieved >10% weight loss (vs. 50% with semaglutide).
An improvement in the lean mass to fat ratio was observed at Week 26, comparing the nimacimab plus semaglutide combination arm to the placebo arm (0.26 vs. 0.02), and the combination arm compared to semaglutide alone (0.26 vs. 0.13).
Nimacimab 200 mg demonstrated a clean safety profile as a monotherapy with placebo-like tolerability. No increase in GI adverse events was observed when combined with semaglutide.
In the safety analysis population, rates of GI adverse events were 27% with nimacimab alone versus 29.5% with placebo, and 57.1% in combination with semaglutide versus 66.7% with semaglutide alone.
No neuropsychiatric concerns were observed. Also, nimacimab 200 mg (as a monotherapy or in combination with semaglutide) did not increase anxiety, insomnia, or depression.
The CBeyond study had an overall discontinuation rate of 27%. Discontinuations across the study were attributed to adverse events, with the placebo group contributing 60% of these discontinuations.
Price Action: SKYE stock is down 60% at $1.90 during the premarket session at the last check on Monday.
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