Skye Bioscience Shares Up On Keeping Novotech As CRO For Phase 1 Trial Of THC Prodrug Candidate For Glaucoma

Skye Bioscience, Inc. SKYE has entered into an agreement with Novotech Health Holdings, a leading full-service contract research organization in Asia-Pacific, for its upcoming Phase 1 study in Australia of its SBI-100 drug candidate for the treatment of glaucoma. The San Diego, California-based biopharmaceutical company, Skye, is  developing proprietary, synthetic cannabinoid-derived molecules to treat glaucoma and other diseases with significant unmet needs.

Novotech is an internationally recognized full-service biotech specialist CRO known for its experience across the Asia-Pacific region. It will work alongside investigators of the planned study to support many 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 stated. "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."

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.

About SBI-100

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.

Price Action

Skye shares were trading 7.42% higher at $0.042 per share at the time of writing Thursday morning.