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Skye Bioscience, Inc., a pharmaceutical company developing a proprietary, synthetic cannabinoid derivative to treat glaucoma, reported that its phase 2 clinical trial protocol has received study level approval from a central institutional review board (IRB). The phase 2 study is a planned evaluation of SBI-100 Ophthalmic Emulsion (OE) in patients with primary open angle glaucoma or ocular hypertension. SBI-100 OE targets the CB1 receptor, which plays a key role in managing intraocular pressure associated with glaucoma.
An IRB, operating under FDA regulations, is designated to assure, both in advance and by periodic review, that appropriate steps are taken to protect the rights and welfare of human subjects participating in biomedical research. IRBs review research protocols and related materials (e.g. informed consent documents and investigator brochures) and have authority to approve, require modifications in (to secure approval), or disapprove research.
A central IRB review process allows for multiple study sites in a multi-center trial to rely on the review of a single (i.e. central) IRB, rather than using multiple IRBs affiliated with each individual research site. The goal of this centralized process is to increase efficiency and decrease duplicative efforts, while enabling the central IRB to take responsibility for all aspects of IRB oversight for each site participating in the centralized review process.
The next steps require each clinical site to provide their site-specific information for the trial to the IRB. In parallel, each clinical site will be submitting the necessary documentation to the US Drug Enforcement Agency, in collaboration with Skye, to be able to conduct research under the Controlled Substances Act (1973).
"Following the FDA's authorization of our Investigational New Drug application in December, we are methodically completing the manufacturing steps and clinical planning to initiate this important phase 2 study of SBI-100 Ophthalmic Emulsion in glaucoma patients in the first half of 2023," said Punit Dhillon, CEO and Chair of Skye. "The central IRB approval is another significant clinical milestone toward our phase 2 initiation in the US as we also continue enrollment in our on-going phase 1 study in Australia."
SBI-100 OE is a novel synthetically-derived molecule formulated as an eye-drop using a propriety nanoemulsion to improve delivery into the eye. SBI-100 OE displayed favourable results in animal studies as a monotherapy and in combination with standard of care (SOC) glaucoma drugs compared to SOC alone and other combinations. The first cohort of healthy participants in Skye's first-in-human phase 1 clinical trial in Australia was dosed in December.
Skye Bioscience is a pharmaceutical company unlocking the potential of cannabinoids through the development of its proprietary cannabinoid derivatives to treat diseases with significant unmet needs.
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