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Skye Bioscience Receives Positive Safety Review in First Multiple-Administration Cohort of Phase 1 Study of SBI-100 Ophthalmic Emulsion
San Diego, California--(Newsfile Corp. - May 15, 2023) - Skye Bioscience, Inc. (OTCQB: SKYE) ("Skye" or the "Company"), a pharmaceutical company developing a
About this update from Skye Bioscience, Inc.
[{"type":"text","content":"San Diego, California--(Newsfile Corp. - May 15, 2023) - Skye Bioscience, Inc. (OTCQB: SKYE) (\"Skye\" or the \"Company\"), a pharmaceutical company developing a proprietary, synthetic cannabinoid derivative to treat glaucoma, reports that the safety review committee (\"SRC\") for its Phase 1 clinical trial of SBI-100 Ophthalmic Emulsion (\"OE\") has reviewed the data from the trial's fourth cohort and provided approval to escalate to the fifth cohort. The data from the fourth cohort was consistent with previous cohorts; there were no serious adverse events and similar mild to moderate drug-related adverse events. The related adverse events reported across all cohorts are typically associated with topical eye treatments.\nIn this first cohort of eight healthy subjects in this trial's multiple ascending dose (\"MAD\") arm, six subjects were topically administered SBI-100 OE at a concentration of 0.5% and two were administered placebo. In the MAD arm, subjects 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.\nSubjects administered SBI-100 OE in the fifth and sixth cohorts will receive doses of 1.0% and 2.0% concentration in late May and late June, respectively.\nIn the completed single ascending dose (\"SAD\") arm of this Phase 1 study, 18 of 24 total subjects across three cohorts received a single dose of SBI-100 OE (the other 6 received placebo) at doses of 0.5%, 1.0% and 2.0%, respectively.\nAbout SBI-100 Ophthalmic Emulsion\nSBI-100 OE is a novel synthetically-derived molecule formulated as an eye-drop using a propriety nanoemulsion to improve delivery into the eye. SBI-100 OE targets the CB1 receptor, which plays a key role in managing intraocular pressure associated with glaucoma. SBI-100 OE displayed favorable results in animal studies as a monotherapy and in combination with standard of care (\"SOC\") glaucoma drugs compared to SOC alone and other combinations.\nAbout Skye Bioscience\nSkye Bioscience is a pharmaceutical company unlocking the potential of cannabinoids through the development of its proprietary cannabinoid derivatives to treat diseases with significant unmet needs. The Company's lead program...