Skye Bioscience, Inc. (SKYE), an obesity and other metabolic health disorder-focused clinical-stage biotechnology company, announced positive interim 52-week data from the combination-therapy arms in the extension Phase 2a CBeyond proof-of-concept study of nimacimab, its lead antibody candidate in obesity.
The positive results from the extension phase of the Phase 2a Cbeyond study include achieving a significant total weight loss of 22.3% in the combination arm of nimacimab and semaglutide, with no weight-loss plateau observed, compared with 19.7% in the placebo plus semaglutide arm after 52 weeks of treatment.
Nimacimab is a peripherally restricted monoclonal antibody inhibitor of the CB1 receptor. Unlike previous CB1-targeting drugs, nimacimab is designed to avoid central nervous system penetration, potentially limiting neuropsychiatric side effects seen with small-molecule antagonists.
In May 2025, the blinded extension of the CBeyond study for combination cohorts was opened for participants assigned to either nimacimab (200 mg dose) plus semaglutide (200 mg dose) or placebo plus semaglutide arms.
Eligible patients completed 26 weeks of treatment and were precluded from being off therapy for longer than 4 weeks. In total, 19 participants in the combination cohorts who completed week 26 were eligible for and elected to enrol in the extension study.
The extension continued for an additional 26 weeks, maintaining their original treatment assignment: 10 were treated with nimacimab plus semaglutide and 9 with placebo plus semaglutide.
Of the 10 participants in the combination arm of nimacimab and semaglutide who joined the extension study, the mean weight loss of 14.4% was observed at 26 weeks.7 participants completed the additional 26 weeks of treatment and lost an additional 7.9% of weight, resulting in a mean weight loss of 22.3% after 52 weeks of treatment, with no weight loss plateau observed. Of the 9 participants in the placebo plus semaglutide arm that joined the extension study, mean weight loss at 26 weeks was 13.9%.7 participants completed treatment of the additional 26 weeks and lost an additional 5.8% of weight during the extension period, resulting in a mean weight loss of 19.7% after 52 weeks of treatment.
Also, the weight regain during treatment interruption was reduced by over 50% - with the nimacimab plus semaglutide cohort regaining only 17.8% of lost weight vs. 37.3% for semaglutide alone during 13-week off-therapy follow-up, demonstrating a durability advantage, the company noted.
In addition, the combination therapy continued to demonstrate safety and was well-tolerated at the tested doses. No serious adverse events or adverse events of special interest were reported during the extension period.
Earlier in October 2025, Skye reported top-line 26-week data from CBeyond showing that the nimacimab and semaglutide combination cohort achieved clinically meaningful weight loss of 13.2% vs 10.25% with semaglutide alone, without plateau.
Full topline reporting of the CBeyond Phase 2a extension data, including nimacimab monotherapy data and 13-week off-therapy follow-up, is expected in Q3 2026.
"These results suggest that we could see even more weight loss with treatment beyond 52 weeks. We also expect even deeper weight loss with more optimised dosing of nimacimab in potential future clinical trials. Importantly, the interim data showed that the combination treatment remains safe and tolerable at the tested doses," said Puneet Arora, MD, FACE, Chief Medical Officer of Skye.
Over the year, SKYE traded between $0.68 and $5.75. The stock is currently up 0.20% at $1.01.
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