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Skye Bioscience Receives Positive Safety Review of Fifth Cohort of Phase 1 Study of SBI-100 Ophthalmic Emulsion
Skye plans to complete enrollment of Phase 1 study in June San Diego, California--(Newsfile Corp. - June 2, 2023) - Skye Bioscience, Inc. (OTCQB: SKYE)
About this update from Skye Bioscience, Inc.
[{"type":"text","content":"Skye plans to complete enrollment of Phase 1 study in June\nSan Diego, California--(Newsfile Corp. - June 2, 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 for its Phase 1 clinical trial of SBI-100 Ophthalmic Emulsion (\"OE\") has reviewed the data from the trial's fifth cohort and provided approval to escalate to the sixth and final cohort of healthy subjects in early June. The data from this second cohort of the multi-administration multiple ascending dose (\"MAD\") arm of the Phase 1 study was consistent with the prior MAD and single ascending dose (\"SAD\") 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 each study cohort, six subjects are topically administered SBI-100 OE and two are administered placebo. In the SAD arm, subjects received one single dose. In the MAD arm, subjects are administered a single dose in the morning and evening (approximately 12 hours later) for five days. In each of the two arms of the study, subjects receiving SBI-100 OE are administrated concentrations of 0.5%, 1.0%, and 2.0% in each of the three respective cohorts. Subjects in the MAD arm 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.\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, SBI-100 OE, is focused on developing a tre...