Skye Bioscience's Obesity Drug Nimacimab Falls Short in Key Study

Skye Bioscience, a San Diego-based biotechnology company, faced a significant setback as its experimental weight loss drug nimacimab failed to meet expectations in a mid-stage clinical trial. The news, announced on Monday, led to a dramatic decline in the company's stock price, with shares plummeting by nearly two-thirds to less than $2 in early trading.

Disappointing Results for Nimacimab Monotherapy

The Phase 2 study revealed that nimacimab, which targets a specific cannabinoid receptor, did not significantly outperform a placebo in weight reduction after 26 weeks of treatment. Patients receiving nimacimab achieved only a 1.5% weight loss, compared to less than 0.3% for those on placebo. Skye Bioscience attributed these underwhelming results to the chosen dose, stating that the 200 milligram weekly injection proved "suboptimal as a monotherapy."

Potential in Combination Therapy

Despite the setback in monotherapy, nimacimab showed more promising results when combined with semaglutide, the active ingredient in Novo Nordisk's popular weight loss drug Wegovy. In this arm of the study, patients receiving the combination therapy experienced a 13% reduction in body weight, compared to just over 10% for those on semaglutide alone.

Skye's Chief Medical Officer, Puneet Arora, suggested that the drug's effects may have been limited by "lower-than-expected drug exposure," which could inform the company's future strategy. The company is now evaluating the data to determine next steps, including the possibility of a "follow-on" Phase 2 study.

Implications for the Obesity Drug Landscape

The results from Skye Bioscience's trial add to a growing body of research on weight loss medicines targeting cannabinoid receptors, particularly CB1. These drugs are intended to enhance the effects of incretin therapies like Wegovy, which have gained significant traction in the obesity treatment market.

Louis Aronne, a company advisor and past president of The Obesity Society, described the study results as the first evidence that drugs like nimacimab "can drive meaningful additional weight loss" beyond incretin therapies alone. This perspective suggests that while nimacimab fell short as a standalone treatment, it may still have potential as part of a combination therapy approach.

The findings also highlight the challenges faced by companies aiming to improve upon popular weight loss drugs. Last September, Novo Nordisk's own CB1-inhibiting drug failed to meet weight loss expectations, underscoring the complexities involved in developing effective obesity treatments.