Skye Bioscience Completes Drug Production for Phase 1 Clinical Study
San Diego, California, Sept. 20, 2022 (GLOBE NEWSWIRE) -- Skye Bioscience, Inc. (OTCQB: SKYE) (“Skye” or the “Company”), a pharmaceutical company developing a proprietary, synthetic cannabinoid derivative to treat glaucoma, has been advised by its contract manufacturer (“CMO”) that it has completed the production of SBI-100 Ophthalmic Emulsion (“SBI-100 OE”) for Skye’s Phase 1 clinical trial. The final drug product will be released and available for clinical use in October, following receipt of acceptable results from quality and analytical testing that has been initiated.
“We are pleased to have completed this critical step toward initiating enrollment for our first-in-human study for SBI-100 OE,” said Punit Dhillon, CEO and Chair of Skye. “Our team is scheduled to conduct our clinical site initiation in the second week of October to train staff and investigators of our clinical partner, CMAX, in Australia. Following site initiation and release of SBI-100 OE drug product, we expect dosing in subjects to begin in November.”
About SBI-100 Ophthalmic Emulsion
To address these challenges, Skye developed SBI-100 OE, a proprietary, synthetic cannabinoid derivative possessing a novel molecular structure and formulation that was rationally designed to enable better penetration of ocular tissue and effective topical delivery of a CB1R agonist. In preclinical studies involving three different species, a nanoemulsion formulation of the drug applied topically to the eye resulted in enhanced therapeutic efficacy and duration of response in lowering IOP. Importantly, these studies also demonstrated advantages compared to today’s standard of care and, if clinically validated in subsequent efficacy studies, may provide a suitable therapeutic window to be a new class of medicine for glaucoma.
About Skye Bioscience
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