Wednesday, March 08, 2023
Skye Bioscience, Inc., a pharmaceutical company developing a proprietary, synthetic cannabinoid derivative to treat glaucoma and ocular hypertension, has completed dosing of the third cohort of eight healthy participants in its Phase 1 clinical trial of its lead product candidate, SBI-100 Ophthalmic Emulsion ("OE"), a cannabinoid receptor type 1 ("CB1R") agonist administered topically onto the eye. The study's safety review committee ("SRC") provided a positive recommendation following a pre-specified review of the data from the second cohort of participants. The SRC also recommended the trial advance into the multiple ascending dose ("MAD") arm of the study. Skye has submitted to the human ethics review committee ("HREC") for approval to initiate the MAD arm.
The objective of this Phase 1, randomized, double-masked, placebo-controlled study is to evaluate the safety, tolerability and pharmacokinetics of SBI-100 OE. Changes in intraocular pressure will also be evaluated. Approximately 48 subjects are divided into three single ascending dose ("SAD") and then three subsequent MAD cohorts, with six participants receiving drug and two participants receiving placebo in each cohort. In the third and final SAD cohort, participants administered drug received a single topical dose of SBI-100 OE at a concentration of 2.0%, compared to concentrations of 0.5% and 1.0% in the first and second SAD cohorts.
Skye's SBI-100 OE possesses a novel molecular structure and nanoemulsion formulation that were designed to enable effective topical delivery and better penetration of a CB1R agonist into ocular tissue. In preclinical studies involving three different species, the drug resulted in enhanced therapeutic efficacy and duration of response in lowering IOP, comparing favorably to the standard of care for treating glaucoma.