Skye Bioscience is putting the kibosh on its SBI-100 candidate for glaucoma, and the company’s entire ophthalmology program, after a mid-stage study did not reach its primary endpoint.
Skye Bioscience announced Monday it is stopping all work on an eye disease candidate, SBI-100 Ophthalmic Emulsion, and its broader ophthalmology pipeline after failing to reach a Phase IIa primary endpoint in lowering intraocular pressure in glaucoma patients.
The Phase IIa trial investigated SBI-100 Ophthalmic Emulsion (OE), a synthetic prodrug of tetrahydrocannabinol (THC), in patients with open-angle glaucoma or ocular hypertension. Patients with elevated intraocular pressure (IOP) received dosing amounts of 1% or 0.5% concentrations of SBI-100 or a placebo, placing one drop in each eye for 14 days, and assessing the change in diurnal intraocular pressure.
However, Skye said the results did not show a statistically significant improvement in IOP over placebo. “The drug was safe and all treated patients completed the study with no early discontinuations due to adverse events,” according to the announcement.
The biotech plans to shut down clinical development and end further spending on SBI-100 OE. The company will also halt any R&D related to SBI-100 and stop any further development of its ophthalmology pipeline. Skye Chief Development Officer Tu Diep said in a statement that it will still evaluate the Phase IIa data and plans to eventually publish the findings.
The company’s stock fell by more than 16% in Monday morning trading. Going forward, Skye said it will funnel all clinical development resources into its metabolic program, while extending its cash runway into 2027.
“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. With this data outcome from our glaucoma program, we will now focus 100% of our efforts on broadening our metabolic clinical pipeline,” Skye CEO Punit Dhillon said in a statement.
Skye’s drug candidate nimacimab, a monoclonal antibody that serves as a negative allosteric modulator to inhibit CB1 signaling, is slated to start a Phase II trial in obesity in the third quarter of 2024 comparing monotherapy and combination arms of nimacimab with a GLP-1R agonist.
“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,” Dhillon said.
Nimacimab was secured through Skye’s purchase of Bird Rock Bio in August 2023, while the company at the time raised $17 million in new capital.
Tyler Patchen is a staff writer at BioSpace. You can reach him at tyler.patchen@biospace.com. Follow him on LinkedIn.
