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SAN DIEGO - Skye Bioscience, Inc. (NASDAQ:SKYE), which has seen its stock surge over 40% in the past six months according to InvestingPro data, announced Monday that its peripherally-restricted CB1 inhibitor antibody, nimacimab, demonstrated clinically meaningful additional weight loss when combined with semaglutide compared to semaglutide alone in its 26-week Phase 2a CBeyond trial.
The combination therapy resulted in 13.2% weight loss compared to 10.25% with semaglutide alone, a statistically significant difference (p=0.0372). Notably, weight loss had not plateaued at the 26-week mark.
However, as a monotherapy, nimacimab failed to meet the primary endpoint for weight loss versus placebo (-1.52% vs. -0.26%). Preliminary pharmacokinetic analysis indicated lower than expected drug exposure at the 200 mg weekly subcutaneous dose, suggesting higher dosing may be needed for monotherapy efficacy.
The safety profile appeared favorable, with no increase in gastrointestinal adverse events when nimacimab was added to semaglutide. Importantly, no neuropsychiatric adverse events associated with nimacimab were reported, addressing a key concern with previous CB1 inhibitors.
"This is the first clinical study to show that the combination of a CB1 inhibitor and a GLP-1 therapeutic can drive clinically meaningful additional weight loss beyond a GLP-1 drug alone," said Louis Aronne, MD, past President of The Obesity Society and clinical advisor to Skye.
In the combination arm, 100% of participants in the per protocol analysis achieved greater than 5% weight loss compared to 85% with semaglutide alone, while 67% achieved greater than 10% weight loss versus 50% with semaglutide alone.
The study also showed improvements in lean mass to fat mass ratio in the combination arm compared to both placebo and semaglutide alone.
Skye is continuing to evaluate the data and considering next steps, including a potential follow-on Phase 2 study. The company expects to report data from the ongoing extension study in Q1 2026.
The information in this article is based on a press release statement from Skye Bioscience.
In other recent news, Skye Bioscience has reported positive results from a Phase 1b study of its CB1-inhibiting antibody, nimacimab, in patients with metabolic-associated steatotic liver disease. The study demonstrated a favorable safety and tolerability profile, with predictable pharmacokinetics and low immunogenicity. Additionally, Skye Bioscience announced promising preclinical data for its obesity treatment, showing that nimacimab led to over 40% weight loss in diet-induced obese mice when combined with tirzepatide. The company is preparing for the release of its Phase 2a CBeyond clinical trial results for the same treatment. Piper Sandler has maintained an Overweight rating on Skye Bioscience, with a $20.00 price target, ahead of these results. Similarly, JMP Securities has reiterated a Market Outperform rating with a price target of $15.00. Skye Bioscience is also hosting a virtual expert panel to discuss the upcoming trial results and the potential of peripheral CB1 inhibition as a therapeutic pathway for obesity. These developments highlight the company’s ongoing efforts in advancing treatments for obesity and liver disease.
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