SAN DIEGO - Skye Bioscience, Inc. (OTCQB: SKYE), a biotechnology company specializing in the development of therapeutic drugs targeting the endocannabinoid system, has announced the completion of its Phase 2a clinical trial for SBI-100 Ophthalmic Emulsion (OE), a novel treatment for patients with elevated intraocular pressure (IOP) related to glaucoma or ocular hypertension.
The Phase 2a study, which dosed 56 patients, was conducted without any early discontinuations due to adverse events, indicating a positive safety profile for the CB1 agonist administered topically to the eye. Topline data from the study is expected to be released in the second quarter of 2024.
SBI-100 OE, designed to address unmet needs in primary open-angle glaucoma (POAG) and ocular hypertension (OHT), was tested in two concentrations of 0.5% or 1.0%, or a placebo, with patients receiving one drop in each eye, twice daily over a period of 14 days. The study aimed to evaluate the drug's ability to lower IOP, its safety, and the comfort of its application.
Skye's Chief Development Officer, Tu Diep, highlighted the rapid enrollment of the study, which was completed ahead of schedule, negating the need for an interim data report. The company is now preparing for database lock activities to analyze the full set of data.
Previous results from a Phase 1 clinical trial of SBI-100 OE showed it was safe and well-tolerated, with no serious adverse events reported. It also demonstrated a mean reduction of intraocular pressure of 23.9% in a subset of healthy volunteers with higher baseline IOP.
The active ingredient in SBI-100 OE is a synthetic THC prodrug that, after conversion, activates CB1 receptors in ocular tissues, potentially lowering IOP in patients with glaucoma and ocular hypertension. Preclinical studies have suggested its effectiveness and favorable comparison to the standard of care in treating glaucoma.
Skye Bioscience is also preparing to initiate a Phase 2 clinical trial for nimacimab, a treatment for obesity, in mid-2024. The company continues to focus on developing first-in-class therapeutics for diseases with metabolic, inflammatory, and fibrotic processes.
This news is based on a press release statement from Skye Bioscience, Inc.
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