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Skye Bioscience Begins Dosing Fifth of Six Cohorts in Phase 1 Clinical Trial of Novel CB1R Agonist
Skye advances multiple ascending dose arm of SBI-100 Ophthalmic Emulsion trial San Diego, California--(Newsfile Corp. - May 17, 2023) - Skye Bioscience, Inc.
About this update from Skye Bioscience, Inc.
[{"type":"text","content":"Skye advances multiple ascending dose arm of SBI-100 Ophthalmic Emulsion trial\nSan Diego, California--(Newsfile Corp. - May 17, 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 started dosing the second cohort of the multiple ascending dose (\"MAD\") arm of 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. Skye will provide an update after the safety review committee completes its planned data review of this cohort.\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. Approximately 48 subjects are randomized into a single ascending dose (\"SAD\") arm (enrollment completed) or MAD arm, with three cohorts per arm and eight participants per cohort. In each cohort, six participants receive SBI-100 OE and two placebo. SBI-100 OE is 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 are administered a single dose in the morning and evening (approximately 12 hours later) for five days. They are 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 cohort 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 a topically-applied eye treatment.\nAbout SBI-100 Ophthalmic EmulsionSkye'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.\n...