Skye progresses to multiple ascending dose arm of SBI-100 Ophthalmic Emulsion trial after completing single ascending dose arm
P1 dosing of novel cannabinoid derivative planned for completion in Q2, with data reporting in Q3
San Diego, California--(Newsfile Corp. - April 27, 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 started dosing of the first cohort of its multiple ascending dose ("MAD") arm of its Phase 1 clinical trial study of its lead product candidate, SBI-100 Ophthalmic Emulsion ("OE"), a cannabinoid receptor type 1 ("CB1R") agonist administered topically onto the eye. Skye will provide an update after the safety review committee completes its planned data review of this cohort.
The objective of this Phase 1, randomized, double-masked, placebo-controlled study is to evaluate the safety, tolerability and pharmacokinetics of SBI-100 OE with different dosing regimens. Changes in intraocular pressure are also being measured. Approximately 48 subjects are randomized into a single ascending dose ("SAD") arm or MAD arm, with three cohorts per arm, and eight participants per cohort. In each cohort, six participants receive SBI-100 OE and two placebo. SBI-100 OE is administered topically in one eye at ascending dose concentrations of 0.5%, 1.0% and 2.0% in the respective cohorts of the SAD and MAD arms. In SAD, participants are administered a single dose in the morning and monitored at the clinical research unit for 24 hours afterwards. In MAD, participants are administered a single dose in the morning and evening (approximately 12 hours later) for five days. They are monitored at the clinical research unit for a total of seven days (including the five days of dosing). This study is being conducted in Adelaide, Australia.
In the SAD arm, SBI-100 OE was well-tolerated, with no drug-related serious adverse events and only mild and moderate adverse events. The reported adverse events are consistent with a topically-applied drug.
"Our Phase 1 study is progressing well. We expect to enroll the second and third cohorts of the MAD arm in May and June, and report topline data in the third quarter," noted Punit Dhillon, Chief Executive Officer and Chair of Skye.
"Considering that we are working on two clinical studies concurrently with a small team, I am also pleased with the preparation for our Phase 2a study. Our Investigational New Drug submission has been authorized by the FDA. We have central and clinical site institutional review board approvals. We are working with each site to update their controlled drug license to include Schedule 1 and with the U.S. Drug Enforcement Agency to permit the shipment of our drug to Finland for formulation and packaging. And we are progressing production preparation with NextPharma in Finland. To allow some additional time for the many moving parts to be completed, as noted in our recent 10K filing we have adjusted the timeline to start dosing for this study to 'mid-year'. We continue to expect to report data from our Phase 2a in Q1 2024," added Mr. Dhillon.
About SBI-100 Ophthalmic Emulsion
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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Email: ir@skyebioscience.com
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FORWARD LOOKING STATEMENTS
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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