Skye will not only halt all work on SBI-100 but end its ophthalmology R&D ambitions entirely. Skye Bioscience’s share price tumbled in pre-market trading Monday, as the biotech announced a strategic refocus in the wake of a phase 2 trial failure. As recently as April, Skye had been attributing its work getting SBI-100 into the phase 2 trial—which completed dosing in February—as one of the reasons for being able to bounce its shares from the over-the-counter securities market to the Nasdaq Global Market. But in response to today’s clinical fail, Skye will not only halt all work on SBI-100 but end its ophthalmology R&D ambitions entirely. From now on, all resources are being funneled into the company’s metabolic program, which is headed up by CB1 inhibitor nimacimab. A phase 2 trial of nimacimab in obesity is due to begin dosing in the third quarter and Skye said the strategic pivot would extend its operating runway into 2027. The company had already “laid the groundwork for our metabolic program” over the last year, according to CEO Punit Dhillon, with the aim of “diversifying our product portfolio’s disease targets and therapeutic mechanisms.”
“With this data outcome from our glaucoma program, we will now focus 100% of our efforts on broadening our metabolic clinical pipeline,” Dhillon added in the June 10 release. “We believe that nimacimab’s unique mechanism of peripheral CB1 inhibition positions it to potentially contribute to the need for higher-quality, sustainable weight loss and better treatments for co-morbid conditions amidst an incretin-biased anti-obesity therapeutic landscape.” “We will look forward to sharing updates on this clinical program and advancing nimacimab through to data in 2025,” the CEO added.