Skye Drops Eye Disease Drug After Phase II Failure, Shifts to Metabolic Program
Skye Bioscience announced on Monday its decision to discontinue all activities related to its eye disease candidate, SBI-100 Ophthalmic Emulsion, and its entire ophthalmology pipeline. This decision follows the failure to meet the primary endpoint in a Phase IIa trial aimed at lowering intraocular pressure (IOP) in patients with glaucoma.
The Phase IIa study focused on SBI-100 Ophthalmic Emulsion (OE), a synthetic prodrug of tetrahydrocannabinol (THC), administered to patients with open-angle glaucoma or ocular hypertension. Participants were given doses of either 1% or 0.5% concentrations of SBI-100 or a placebo, with one drop placed in each eye daily over a 14-day period. The study aimed to monitor changes in diurnal intraocular pressure.
Despite these efforts, the results did not demonstrate a statistically significant reduction in IOP compared to the placebo. According to the company’s announcement, the drug was found to be safe, and all patients completed the study without any early discontinuations due to adverse events.
As a result of these findings, Skye Bioscience will cease all clinical development and further expenditure on SBI-100 OE. The company will also stop any research and development efforts related to SBI-100 and will terminate further development within its ophthalmology pipeline. Chief Development Officer Tu Diep stated that while the company will halt these activities, it intends to evaluate the Phase IIa data and eventually publish the findings.
Following the announcement, Skye’s stock dropped by over 16% during Monday morning trading. Looking ahead, the company plans to redirect all clinical development resources towards its metabolic program, aiming to extend its financial runway into 2027.
“In the past year, we have established the foundation for our metabolic program with objectives to diversify our product portfolio's disease targets and therapeutic mechanisms, significantly expanding our clinical and business opportunities,” said Skye CEO Punit Dhillon in a statement. He emphasized that the company would now devote all of its efforts to expanding its metabolic clinical pipeline in light of the recent glaucoma program data.
One of Skye’s prominent drug candidates, nimacimab, a monoclonal antibody acting as a negative allosteric modulator to inhibit CB1 signaling, is set to begin a Phase II trial for obesity in the third quarter of 2024. This trial will compare the efficacy of nimacimab as a monotherapy and in combination with a GLP-1R agonist.
Dhillon expressed optimism about nimacimab's potential, stating, “We believe that nimacimab’s unique mechanism of peripheral CB1 inhibition positions it to contribute significantly to the need for sustainable weight loss and improved treatments for co-morbid conditions within an incretin-focused anti-obesity therapeutic landscape.”
Nimacimab was acquired through Skye's purchase of Bird Rock Bio in August 2023, during which the company also raised $17 million in new capital.
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