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Skye Bioscience Completes Enrollment of Phase 1 Clinical Trial of Novel CB1R Agonist, SBI-100 Ophthalmic Emulsion
Skye completes dosing of final cohort of healthy volunteers in study of first-and-only-in-class proprietary cannabinoid derivative San Diego,
About this update from Skye Bioscience, Inc.
[{"type":"text","content":"Skye completes dosing of final cohort of healthy volunteers in study of first-and-only-in-class proprietary cannabinoid derivative\nSan Diego, California--(Newsfile Corp. - June 12, 2023) - Skye Bioscience, Inc. (OTCQB: SKYE) (\"Skye\" or the \"Company\"), a pharmaceutical company developing a proprietary, synthetic cannabinoid derivative to treat glaucoma and ocular hypertension, has completed dosing of the third and final cohort of the multiple ascending dose (\"MAD\") arm and overall planned enrollment of 48 healthy subjects in its Phase 1 clinical trial for its lead product candidate, SBI-100 Ophthalmic Emulsion (\"OE\"), a cannabinoid receptor type 1 (\"CB1R\") agonist administered topically onto the eye. In the upcoming weeks, the safety review committee will assess the last cohort' data, as they have for all previous cohorts, and Skye will then provide an update. Skye expects to provide a preliminary data report in Q3.\nThe objective of this Phase 1, randomized, double-masked, placebo-controlled study is to evaluate the safety, tolerability and pharmacokinetics of SBI-100 OE with different dosing regimens. Changes in intraocular pressure are also being measured. Participants were randomized into a single ascending dose (\"SAD\") arm or MAD arm, with three cohorts per arm and eight participants per cohort. In each cohort, six participants received SBI-100 OE and two placebo. SBI-100 OE was administered topically in one eye at ascending dose concentrations of 0.5%, 1.0% and 2.0% in the respective cohorts of the two arms. In the MAD arm, participants were administered a single dose in the morning and evening (approximately 12 hours later) for five days. They were monitored at the clinical research unit for a total of seven days (including the five days of dosing). This study is being conducted in Adelaide, Australia.\nIn the completed SAD arm and first two cohorts of the MAD arm, SBI-100 OE was well-tolerated, with no drug-related serious adverse events and only mild and moderate adverse events. The reported adverse events are consistent with topically-applied eye treatments.\nAbout SBI-100 Ophthalmic Emulsion\nSkye'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 ...