Skye Bioscience has signed an agreement under which Novotech Health will serve as contract research organisation (CRO) for the upcoming Phase I clinical trial of the former’s drug candidate SBI-100 to treat glaucoma in Australia.
Skye plans to commence the first-in-human Phase I trial in the second quarter with results anticipated in the second half of this year. Furthermore, it intends to begin a Phase II proof-of-concept trial before the end of this year.
Under the deal, Novotech will aid investigators in areas of the trial including feasibility analyses, statistical assessment, ethics committee and regulatory filings, medical monitoring.
Additionally, the company will support other aspects of the study including safety services, managing data, central lab services, reporting as well as managing the project and vendors. A full-service biotech specialist CRO, Novotech has experience in the Asia-Pacific region.
Skye Bioscience CEO Punit Dhillon said: “We are pleased to bring on one of Asia-Pacific’s premier biotech specialist CROs to support our first-inhuman clinical study.
“With Novotech’s extensive experience in conducting clinical trials, we are optimally positioned to execute this Phase I programme of SBI-100 in Australia where we expect to conduct this important phase of our development quickly and cost-effectively.”
Skye is currently working on a product and clinical development strategy to realise the complete potential of cannabinoids to treat glaucoma and ailments with substantial unmet needs.
A prodrug of tetrahydrocannabinol (THC), SBI-100 is a topical formulation being developed for the treatment of glaucoma.
By applying rational drug design, Skye chemically altered THC to develop a synthetic molecule to safely realise THC’s recognised positive effects.
SBI-100 facilitates improved local administration of the drug into the eye, less systemic side effects and the possibility for neuroprotection.
The drug candidate was found to offer an improved reduction in intraocular pressure versus various currently marketed classes of drugs, in preclinical studies.
Intraocular pressure is a crucial cause of vision loss and the preclinical data indicates SBI-100’s ability as a transformative therapy option for glaucoma globally.