Skye Bioscience Doses Third Cohort of Phase 1 Clinical Trial of SBI-100 Ophthalmic Emulsion
San Diego, California--(Newsfile Corp. - March 7, 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 third 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 administered topically onto the eye. The study's safety review committee ("SRC") provided a positive recommendation following a pre-specified review of the data from the second cohort of participants. The SRC also recommended the trial advance into the multiple ascending dose ("MAD") arm of the study. Skye has submitted to the human ethics review committee ("HREC") for approval to initiate the MAD arm.
The objective of this Phase 1, 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. Approximately 48 subjects are divided into three single ascending dose ("SAD") and then three subsequent MAD cohorts, with six participants receiving drug and two participants receiving placebo in each cohort. In the third and final SAD cohort, participants administered drug received a single topical dose of SBI-100 OE at a concentration of 2.0%, compared to concentrations of 0.5% and 1.0% in the first and second SAD cohorts.
Skye's SBI-100 OE possesses a novel molecular structure and nanoemulsion formulation that were designed to enable effective topical delivery and better penetration of a CB1R agonist into ocular tissue. In preclinical studies involving three different species, the drug resulted in enhanced therapeutic efficacy and duration of response in lowering IOP, comparing favorably to the standard of care for treating glaucoma.
About Skye Bioscience
Skye 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.
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This 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 results, financial condition, and stock price could be materially negatively affected. In some cases, forward-looking statements can be identified by terminology including "anticipated," "plans," "goal," "focus," "aims," "intends," "believes," "can," "could," "challenge," "predictable," "will," "would," "may" or the negative of these terms or other comparable terminology. We operate in a rapidly changing environment, and new risks emerge from time to time. As a result, it is not possible for our management to predict all risks, nor can we assess the impact of all factors on our business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements the Company may make. Risks and uncertainties that may cause actual results to differ materially include, among others, our capital resources, uncertainty regarding the results of future testing and development efforts and other risks that are described in the Risk Factors section of Skye's most recent annual or quarterly report filed with the Securities and Exchange Commission. Except as expressly required by law, Skye disclaims any intent or obligation to update these forward-looking statements.
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