Skye Bioscience, Inc. (NASDAQ: SKYE) has revealed notable interim data from the extension phase of its Phase 2a CBeyond study, assessing the efficacy and safety of nimacimab in combination with semaglutide (Wegovy) for obesity treatment.
The CBeyond trial (NCT06577090) explores nimacimab, a negative allosteric modulating antibody designed to inhibit peripheral CB1 receptors. The main focus of the extension phase, initiated in May 2025, has been to evaluate two combination therapy cohorts: participants receiving nimacimab alongside semaglutide, and a counterpart group administered placebo plus semaglutide.
Semaglutide, marketed by Novo Nordisk (NYSE: NVO) under the brand names Wegovy and Ozempic, is a glucagon-like peptide-1 receptor (GLP-1R) agonist currently approved for weight management and diabetes treatment.
Interim Weight Loss Outcomes
Within the nimacimab plus semaglutide cohort, 10 participants entered the extension phase. After 26 weeks of continued treatment, these participants exhibited an average weight reduction of 14.4%. Furthermore, seven participants completed an additional 26 weeks, culminating in a mean total weight loss of 22.3% at the one-year mark. Notably, this data showed no indication of weight loss plateauing during extended treatment.
In the placebo plus semaglutide group, nine participants proceeded into the extension. Their mean weight loss at 26 weeks was 13.9%, while seven participants who continued for a full 52 weeks experienced a cumulative average weight decrease of 19.7%.
Safety Profile and Tolerability
The combination therapy was well tolerated across tested doses. During the extension phase, no serious adverse events or adverse events of special interest were reported, underlining a favorable safety profile for nimacimab when administered with semaglutide.
Previous Data and Weight Maintenance
Earlier topline results from October 2025 noted that after 26 weeks, the nimacimab plus semaglutide group achieved a clinically relevant weight loss of 13.2%, notably higher than the 10.25% observed with semaglutide alone. Importantly, no weight loss plateau was noted at that stage.
Monotherapy with nimacimab did not meet primary efficacy endpoints, showing only minimal weight loss (1.52%) contrasted with placebo (0.26%).
During a 13-week follow-up off therapy, participants continuing combination treatment exhibited only a 17.8% regain of lost weight. This contrasts with a 37.3% weight regain among those treated with semaglutide alone at 26 weeks, suggesting a potential durability benefit in the combination approach.
Future Data Expectations and Analyst Commentary
Skye Bioscience plans to release the complete topline Phase 2a extension data, including nimacimab monotherapy results and 13-week post-treatment follow-up, in the third quarter of 2026.
William Blair analysts recently commented on the data, highlighting that Skye's cash runway extends into the fourth quarter of 2026. They indicated that a comprehensive Phase 2a data analysis could increase investor interest if it supports a correlation between drug exposure and weight loss.
Additionally, in September 2025, Skye announced promising preclinical outcomes combining nimacimab with Eli Lilly’s (NYSE: LLY) tirzepatide in animal obesity models.
Market Reaction
Following the announcement, Skye Bioscience’s shares traded down 5.53%, closing at $0.95 according to Benzinga Pro data.