Novotech hired to run Skye’s glaucoma drug trial

Australian CRO Novotech has been hired to run a trial of a cannabinoid-based glaucoma treatment being developed by Skye Bioscience.

Under the agreement – financial terms of which were not disclosed – Novotech will manage a Phase I study of SBI-100 that is due to start in the second quarter of the year.

The firm will support aspects of the trial including feasibility assessments, ethics committee and regulatory submissions, data management, statistical analysis and medical monitoring.

The CRO will also provide safety testing, central lab services, reporting, and project and vendor management.

Skye Biosciences’ CEO Punit Dhillon cited Novotech’s track record of running first-in-human studies in the Asia-Pacific region as the primary motivation for the deal.

"With Novotech's extensive experience in conducting clinical trials, we are optimally positioned to execute this Phase I program of SBI-100 in Australia where we expect to conduct this important phase of our development quickly and cost-effectively."

Data from the trial is due to be reported in the second half of the year.

Skye also said it plans to initiate a proof-of-concept Phase II clinical study of SBI-100 before the end of the year.

Ocular delivery

San Diego, California-based Skye develops proprietary, synthetic cannabinoid-derived molecules to treat diseases with significant unmet needs.

SBI-100, for example, is a proprietary prodrug of tetrahydrocannabinol.

Skye is developing it as a topical formulation, specifically as an ophthalmic nano-emulsion. The idea is that delivery of the drug into the eye will enhance its therapeutic effects and reduce the risk of potential side effects.

In preclinical studies, the drug demonstrated superior lowering of intraocular pressure - a key cause of vision loss associated with glaucoma - compared to several approved products.

Experience

Novotech’s experience in eye disease includes knowledge gained from its 2017 partnership with the Asian Eye Institute, a private eye centre in the Philippines.

Under the agreement AEI agreed to provide the Australian CRO AEI with access to its will provide its professional and clinical trial expertise including its knowhow in feasibility studies, principal investigator selection, patient recruitment and execution.

Image: Stock Photo Secrets