San Diego, Calif, March 03, 2022 (GLOBE NEWSWIRE) — Skye Bioscience, Inc. (OTCQB: SKYE) (“SKYE” or the “Company”), a biopharmaceutical company developing proprietary, synthetic cannabinoid-derived molecules to treat glaucoma and other diseases with significant unmet need, has entered into an agreement with Novotech Health Holdings (“Novotech”), a leading full-service contract research organization (“CRO”) in Asia-Pacific, for its upcoming Phase 1 study in Australia of its SBI-100 drug candidate for the treatment of glaucoma.
Novotech is an internationally recognized full-service biotech specialist CRO known for its experience across the Asia-Pacific region. Novotech will work alongside investigators of the planned study to support aspects of the clinical trial including feasibility assessments, ethics committee and regulatory submissions, data management, statistical analysis, medical monitoring, safety services, central lab services, reporting, and project and vendor management.
“We are pleased to bring on one of Asia-Pacific’s premier biotech specialist CROs to support our first-inhuman clinical study,” stated Punit Dhillon, CEO of Skye Bioscience. “With Novotech’s extensive experience in conducting clinical trials, we are optimally positioned to execute this Phase 1 program of SBI-100 in Australia where we expect to conduct this important phase of our development quickly and cost-effectively.”
SKYE is actively pursuing a product and clinical development plan with the intent to unlock the full potential of cannabinoids for glaucoma and diseases with significant unmet needs. The company expects to initiate its first-in-human Phase 1 study in Q2-22 with data to be reported in the second half of 2022. Additionally, the Company intends to initiate its proof-of-concept Phase 2 study before the end of the year and will continue to announce its initiatives as they unfold.
SBI-100, a proprietary prodrug of tetrahydrocannabinol (“THC”), is a topical formulation under development to treat glaucoma. Through the application of rational drug design, SKYE chemically modified THC to create a unique synthetic molecule with the intent to safely realize the known positive effects of THC. SBI-100 enables enhanced local delivery of the drug into the eye, reduced systemic side effects and the potential for neuroprotection. In preclinical studies, SBI-100 demonstrated superior lowering of intraocular pressure, a key cause of vision loss, compared to the top commercially marketed classes of drugs, representing a potentially transformative treatment option for glaucoma patients worldwide.
About Skye Bioscience
Skye Bioscience Inc. is a biopharmaceutical company unlocking the pharmaceutical potential of cannabinoids through the development of its proprietary, cannabinoid-derived molecules to treat diseases with significant unmet needs. The company’s lead program, SBI-100, is focused on treating glaucoma, a disease with no cure and the world’s leading cause of irreversible blindness. In preclinical studies, SBI-100 demonstrated intraocular pressure lowering capabilities in patients with glaucoma or elevated intraocular pressure that is superior to the current standard of care. For more information, please visit: www.skyebioscience.com.
About Novotech Health Holdings
Novotech is a leading Asia-Pacific biotech specialist. Novotech is a full-service CRO with integrated labs and Phase 1 facilities providing drug development consulting and clinical development services. It has been instrumental in the success of approximately 3,700 clinical trials across all trial phases and therapeutic areas. Novotech is uniquely positioned to serve biopharmaceutical clients conducting clinical trials in Asia and globally.
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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 cannabinoidderived 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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