Skye bets on anti-obesity antibody post-glaucoma drug setback

Skye Bioscience recently announced the discontinuation of its SBI-100 ophthalmology program after the treatment did not meet expectations in a Phase IIa trial involving patients with primary open-angle glaucoma or ocular hypertension. This news led to a 25% drop in the company's shares during premarket trading on Monday. In response, the company is shifting its focus to the highly competitive anti-obesity market, centering its efforts on its remaining pipeline candidate, nimacimab. This strategic pivot is aimed at extending the company's financial resources until 2027, following its recent uplisting to the Nasdaq exchange.

CEO Punit Dhillon commented on the strategic shift, stating, "In the last year, we laid the groundwork for our metabolic program with the goals of diversifying our product portfolio's disease targets and therapeutic mechanisms, while significantly expanding our clinical and business opportunities." Dhillon emphasized that the company will now fully concentrate on expanding its metabolic clinical pipeline, given the recent outcomes from the glaucoma program.

The Phase IIa study for SBI-100 involved 56 patients who were administered the ophthalmic emulsion at two different concentrations over a period of 14 days, with twice-daily dosing. Despite its safety profile, with no participants discontinuing due to adverse effects, the treatment failed to achieve statistically significant reductions in diurnal intraocular pressure when compared to a placebo.

Looking forward, Skye Bioscience is placing its bets on nimacimab, a drug designed as a negative allosteric modulator to inhibit the cannabinoid 1 receptor (CB1) signaling in peripheral tissues. Dhillon has high hopes for nimacimab, describing it as having a "unique mechanism of peripheral CB1 inhibition," which may contribute to more effective, sustainable weight loss and improved treatments for co-morbid conditions, especially in the context of an anti-obesity therapeutic landscape that is increasingly focused on incretins.

The company plans to initiate a Phase II trial for nimacimab in the third quarter, which will evaluate its efficacy in treating obesity. This trial will include both monotherapy and combination arms with a GLP-1 agonist. Skye had previously indicated intentions to start a mid-stage study of the drug in both obesity and chronic kidney disease in the first half of the year. Dhillon expressed optimism about the upcoming trials, stating, "We look forward to sharing updates on this clinical program and advancing nimacimab through to data in 2025."

By focusing its resources and efforts on nimacimab, Skye Bioscience aims to carve out a niche in the anti-obesity market, which is known for its intense competition and constant innovation. This strategic shift not only aligns with the company's broader goals of diversifying its product portfolio but also seeks to secure its financial viability in the coming years.