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Skye Bioscience Doses Second Cohort of Phase 1 Clinical Trial of SBI-100 Ophthalmic Emulsion
San Diego, California--(Newsfile Corp. - February 13, 2023) - Skye Bioscience, Inc. (OTCQB: SKYE) ("Skye" or the "Company"), a pharmaceutical company
About this update from Skye Bioscience, Inc.
[{"type":"text","content":"San Diego, California--(Newsfile Corp. - February 13, 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 second 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 delivered topically into the eye. In the second single ascending dose (\"SAD\") cohort, participants received a single topical dose of SBI-100 OE at a concentration of 1.0%, compared to a concentration of 0.5% in the first SAD cohort.\nSkye received a positive recommendation following a pre-specified data review by the study's safety review committee (\"SRC\") of the dosing of the first cohort of participants. The SRC recommended that the trial continue without modification. Participants in the second cohort were also monitored for safety and tolerability over three days following dose administration, and the SRC will review this data as per the study protocol. Skye expects to enroll the SAD arm's third and last cohort in March, in which participants will receive a single dose of SBI-100 OE at 2.0%.\nThe objective of this 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. In this two-part study, a total of approximately 48 subjects are divided into three SAD and then three subsequent multiple ascending dose cohorts. The trial is being conducted by CMAX Clinical Research in Adelaide, Australia.\nAbout Glaucoma\nAbout 60 million people globally suffer from the debilitating effects of glaucoma, according to the Glaucoma Research Foundation, and even more suffer from ocular hypertension, as represented by the 3% of the US population reported by the British Journal of Ophthalmology. There is a need for a new class of drugs that relies on different mechanisms to affect disease progression.\nIncreased intraocular pressure (IOP) is a key risk factor in the progression of glaucoma. The first observations that consuming cannabis lowered IOP in humans took place in the early 1970s, which led to a significant amount of research on the effects ...