Skye Bioscience Receives Australian Ethics Committee Approval to Start First-in-Human Phase 1 Study …

Lead drug candidate has shown superior and longer-lasting lowering of intraocular pressure, a risk factor associated with glaucoma, in preclinical studies

 Skye Bioscience, Inc. (OTCQB: SKYE) (“Skye” or the “Company”), a pharmaceutical company developing a proprietary, synthetic cannabinoid derivative to treat glaucoma, has received regulatory approval to begin its first-in-human Phase 1 clinical study of SBI-100 Ophthalmic Emulsion (“SBI-100 OE”) from the Australian Human Research Ethics Committee (“HREC”). SBI-100 OE is a patented drug representing a new class of therapeutics to potentially treat glaucoma.

The primary endpoints for this randomized, double-masked, placebo-controlled Phase 1 study of SBI-100 OE are an assessment of safety and tolerability of the drug in healthy volunteers. The secondary endpoint is an assessment of pharmacokinetics. The study will also measure changes to intraocular pressure. A total of 48 subjects will be administered SBI-100 OE or placebo in single ascending dose (SAD) and multiple ascending dose (MAD) arms. Preliminary top-line data is expected in Q4 and final data in Q1 of 2023.

In the study, each arm will consist of three cohorts of eight subjects, six receiving SBI-100 OE and two receiving placebo. In the SAD arm, each subject will be administered a single 35uL drop to one study eye of placebo or SBI-100 OE at concentrations of 0.5%, 1.0% and 2.0% of active drug in cohorts one, two, and three, respectively. In the MAD arm, each subject will receive two drops per day over five days using the respective dose levels of the SAD arm. A Safety Review Committee will monitor the study and review safety data before approving escalation to the next cohort.

“After submitting our clinical trial protocol to HREC in March, we are pleased to receive their approval and look forward to assessing SBI-100 Ophthalmic Emulsion for the first time in humans,” said Tu Diep, Chief Development Officer of Skye. “Decades of research have…

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