Skye Bioscience has published 52-week data on its investigational obesity drug combination, linking the cocktail to 22.3% total weight loss as it works to recover from its failure to hit the primary endpoint.
The phase 2 trial assessed 200 mg of the peripherally restricted CB1 inhibitor nimacimab as a monotherapy and in combination with semaglutide, the GLP-1 receptor agonist Novo Nordisk markets as Ozempic and Wegovy. Weight loss on single-agent nimacimab was statistically no greater than on placebo at Week 26, a result that caused the trial to fail and knocked the biotech’s stock when it was announced back in October.
Still, Skye kept tracking patients for a further 26 weeks in an extension study.
About half of the patients who received either nimacimab or placebo in combination with semaglutide continued on the same regimen. Weight loss increased from 14.4% at Week 26 to 22.3% at Week 52 in patients who kept taking nimacimab and semaglutide. Weight loss in the semaglutide cohort rose from 13.9% at Week 26 to 19.7% at Week 52.
Weight loss on nimacimab and semaglutide was yet to plateau at Week 52, leading Skye Chief Medical Officer Puneet Arora, M.D., to speculate in a statement that patients could shed more pounds in longer studies. Arora flagged optimized dosing as another factor that could improve weight loss.
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Meanwhile, William Blair analysts pointed to a potential pause in treatment between the main study and the extension portion as one of the factors that could “complicate comparisons across arms.”
Skye also shared data on patients who stopped treatment at Week 26. Over the next 13 weeks, patients who had received nimacimab and semaglutide regained 17.8% of their lost weight. Patients who came off placebo and semaglutide regained 37.3% of their lost weight over 13 weeks.
The company reported no serious adverse events or adverse events of special interest in the extension period. Neuropsychiatric safety was a focus going into the 26-week readout, but Skye saw no increase in anxiety, insomnia or depression resulting from treatment with nimacimab. The company plans to share full data from the extension period, including nimacimab monotherapy results, in the third quarter.
Skye will characterize peripheral drug exposure at higher doses and develop plans to enter phase 2b. Last month, the company told investors it planned to start the phase 2b study in the third quarter of 2026. Skye ended September with $35.3 million, a sum it forecast would fund operations into 2027.
William Blair analysts added they were focused on Skye’s third-quarter update, which is set to include data from the 300 mg weekly nimacimab arm. These data “should provide clinical insight into whether higher nimacimab dosing could lead to a higher magnitude of weight loss,” they said in a Feb. 2 note.
