Skye Bioscience Retains Novotech as CRO for Phase 1 Trial of Glaucoma Drug Candidate

Skye Bioscience, Inc. has recently entered into an agreement with Novotech Health Holdings 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,” said 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.

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, visit www.skyebioscience.com.

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.