San Diego, Calif., April 28, 2022 (GLOBE NEWSWIRE) — Skye Bioscience, Inc. (SKYE) (“Skye” or the “Company”), a pharmaceutical company developing proprietary synthetic cannabinoid derivatives to treat glaucoma and d ‘Other Diseases with Significant Unmet Need, has retained CMAX Clinical Research (“CMAX”) to facilitate the recruitment and administration of drugs to healthy volunteers for Skye’s Phase 1 study of its lead product candidate, SBI-100 Ophthalmic Emulsion (“SBI-100 OE”). This study will be conducted at CMAX’s purpose-built independent clinical trial facilities in Adelaide, Australia. CMAX is one of Australia’s largest and most experienced clinical trial operators and specializes in early phase studies. SBI-100 OE is being developed to potentially treat glaucoma.
“We look forward to conducting this first-in-man trial for SBI-100 ophthalmic emulsion,” said Dr. Sepehr Shakib, Consulting Medical Director of CMAX and Principal Investigator of the SBI-100 OE Phase 1 study. “We have submitted the protocol for this study to the Human Research Ethics Committee (HREC) We are working closely with the Skye team to prepare for the recruitment of our first participants in this study after HREC approval and filing of the notification of clinical trial at the Australian Therapeutics Goods Administration.”
“CMAX, along with our Principal Investigator, Professor Shakib, are highly skilled with decades of experience conducting first-in-human clinical trials. They are excellent complements to our recently selected contract research organization for this study, Novotech,” said Tu Diep, Skye’s chief development officer. “We are on track to begin enrolling subjects in the second quarter.”
CMAX will conduct the Phase 1 single ascending dose (SAD) and multiple ascending dose (MAD) study of Skye in healthy volunteers, evaluating the safety and pharmacokinetics of SBI-100 OE under good clinical practice ( “GCP”). GCP compliance is a requirement for the resulting data to be fully recognized and accepted by regulatory authorities of the US Food & Drug Administration, UK Medicines and Health Products Regulatory Agency, EU European Medicines Agency and Australian Therapeutic Goods Administration. Final data from this study is expected in the fourth quarter of this year.
About SBI-100 Ophthalmic Emulsion (SBI-100OE)
SBI-100 Ophthalmic Emulsion is a proprietary formulation of a synthetic prodrug rationally designed to enhance the therapeutic utility of a cannabinoid type 1 receptor agonist to create a new class of drugs to treat glaucoma. In preclinical studies, SBI-100 OE demonstrated superior reduction of intraocular pressure, a key risk factor in glaucoma-related disease progression, in terms of intensity and duration compared to currently “standard” medications. of care “. It has also shown characteristics that may allow topical application once a day.
About Skye Bioscience
Skye Bioscience, Inc. is a pharmaceutical company harnessing the potential of cannabinoids through the development of its proprietary cannabinoid derivatives to treat diseases with high unmet needs. The company’s lead program, SBI-100 ophthalmic emulsion, is being developed for the treatment of glaucoma, an incurable disease and the world’s leading cause of irreversible blindness. For more information, please visit: www.skyebioscience.com.
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Phone: (858) 410-0266
This letter contains forward-looking statements, including statements regarding our product development, business strategy, timing of clinical trials and commercialization of cannabinoid-derived therapeutic products. These 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 if such assumptions prove incorrect, our business, results of operations, financial condition and stock price could be materially adversely affected. In some cases, forward-looking statements may be identified by terminology including “anticipates”, “plans”, “objective”, “focused”, “aims”, “intends”, “believes”, “may”, ” could”, “contest”, “foreseeable”, “will”, “could”, “could” or the negative form of these terms or any other comparable terminology. We operate in a rapidly changing environment and new risks emerge from time to time. Accordingly, it is not possible for our management to predict all risks, nor to assess the impact of all factors on our business or the extent to which any one factor, or combination of factors, may cause that actual results differ materially from those contained in any forward-looking statements the Company may make. The risks and uncertainties that could 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 described in the Risk Factors section. risk 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 intention or obligation to update these forward-looking statements.