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Skye Bioscience Receives Positive Safety Review of Third Cohort in Phase 1 Study of SBI-100 Ophthalmic Emulsion
Enrollment started for multiple ascending dose arm of Phase 1 study San Diego, California--(Newsfile Corp. - April 4, 2023) - Skye Bioscience, Inc. (OTCQB:
About this update from Skye Bioscience, Inc.
[{"type":"text","content":"Enrollment started for multiple ascending dose arm of Phase 1 study\nSan Diego, California--(Newsfile Corp. - April 4, 2023) - Skye Bioscience, Inc. (OTCQB: SKYE) (\"Skye\" or the \"Company\"), a pharmaceutical company developing a proprietary, synthetic cannabinoid derivative to treat glaucoma, has received a positive recommendation following a pre-specified data review by the safety review committee (\"SRC\") based on dosing of the third cohort of eight healthy participants in the single ascending dose arm of its Phase 1 study of SBI-100 Ophthalmic Emulsion (\"OE\"). The SRC determined that in Cohort 3, the highest dose cohort (2.0% concentration), the data was consistent with Cohorts 1 and 2 (0.5% and 1.0% concentration, respectively), with no serious adverse events, and mild and moderate drug related adverse events.\nBased on the SRC's prior agreement, as well as the human ethics review committee (\"HREC\") approval to start the multiple ascending dose (\"MAD\") arm of the study, enrollment for the first cohort of the MAD arm (fourth cohort of the Phase 1) has started. Participant dosing is planned for late April.\nDetails about SBI-100 Ophthalmic Emulsion and the Phase 1 clinical trial design can be found in this previous news release.\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 treatment for glaucoma, the world's leading cause of irreversible blindness. For more information, please visit: www.skyebioscience.com.\nCONTACT\nInvestor Relations\nEmail: [email protected]\nPhone: (858) 410-0266\nFORWARD-LOOKING STATEMENTS\nThis letter contains forward-looking statements, including statements regarding our product development, business strategy, the timing of clinical trials, and commercialization of cannabinoid-derived therapeutics. Such statements and other statements in this press release that are not descriptions of historical facts are forward-looking statements that are based on management's current expectations and assumptions and are subject to risks and uncertainties. If such risks or uncertainties materialize or such assumptions prove incorrect, our business, operating resul...