Skye Bioscience, Inc. (NASDAQ:SKYE) on Monday shared interim 52-week data from the combination therapy arms in the extension phase of the Phase 2a CBeyond proof-of-concept study of nimacimab.
Skye Phase 2a clinical trial (NCT06577090) in obesity for nimacimab, is a negative allosteric modulating antibody that peripherally inhibits CB1. This study is also assessing the combination of nimacimab and a GLP-1R agonist (Wegovy).
Interim Data Summary
The blinded extension of the CBeyond study for combination cohorts was opened in May 2025 for participants assigned to either nimacimab plus semaglutide or placebo plus semaglutide arms.
Semaglutide is marketed by Novo Nordisk A/S (NYSE:NVO) under the brand names Wegovy and Ozempic.
Of the 10 participants in the nimacimab plus semaglutide arm who joined the extension study, the mean weight loss at 26 weeks was 14.4%.
Seven 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.
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.
Of the 9 participants in the placebo plus semaglutide arm that joined the extension study, the mean weight loss at 26 weeks was 13.9%.
Seven (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.
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 compared with semaglutide alone (-13.2% vs -10.25%), with no plateau observed.
The nimacimab monotherapy arm did not achieve the primary endpoint of weight loss compared to placebo (-1.52% vs. -0.26 for placebo, mITT).
The participants treated with nimacimab + semaglutide that continued to the 13-week off-therapy follow-up regained only 17.8% of the total weight loss at 26 weeks, which represents a greater than 50% mitigation of weight rebound.
In comparison, semaglutide treatment alone demonstrated a weight regain of 37.3% from the weight lost at 26 weeks, indicating a potential durable response to treatment.
Topline data from CBeyond Phase 2a extension data, including nimacimab monotherapy data and 13-week off-therapy follow-up, is expected in the third quarter of 2026.
Analyst View
William Blair wrote, “With a cash runway into the fourth quarter of 2026, a more substantive analysis of the Phase 2a CBeyond study could drive investor interest, pending data supportive of exposure/weight loss relationship.”
In September 2025, Skye Bioscience reported positive results from two preclinical obesity studies testing nimacimab alongside Eli Lilly and Co.’s (NYSE:LLY) tirzepatide.
SKYE Price Action: Skye Bioscience shares were down 5.53% at $0.95 at the time of publication on Monday, according to Benzinga Pro data.
Photo by Tobias Arhelger via Shutterstock
