Skye Bioscience Inc (OTCQB:SKYE) announced that it has entered into an agreement with Novotech Health Holdings, a leading full-service contract research organization (CRO) in Asia-Pacific, for the upcoming Phase 1 study in Australia of its SBI-100 drug candidate for the treatment of glaucoma.
"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, in a statement.
He added: "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."
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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 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.
Skye is actively pursuing a product and clinical development plan 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.
Contact Ritika at ritika@proactiveinvestors.com