Skye Bioscience Inc (OTCQB:SKYE) said it has submitted an Investigational New Drug application (IND) to the US Food and Drug Administration (FDA) for its SBI-100 Ophthalmic Emulsion (SBI-100 OE), which it is developing for the treatment of glaucoma.
Once opened, the IND will allow Skye to conduct clinical trials in the US, the pharmaceutical company said.
"The submission of this IND represents a significant amount of work and accomplishment at Skye over the last 12 months and marks a major achievement for the company," said Tu Diep, chief development officer of Skye in a statement.
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"With the successful submission of two regulatory filings in two different jurisdictions, Australia and the United States, Skye is well on its way in advancing its proactive development strategy for SBI-100 OE.
“We look forward to enrolling our Phase 1 study, which will give us important data about the safety and tolerability of SBI-100 OE. With respect to our planned Phase 2 study, we intend to move both programs forward independently," he added.
SBI-100 OE is a novel synthetic molecule targeting the CB1 receptor that is formulated using a proprietary nanoemulsion to improve delivery into the eye. In preclinical studies, SBI-100 OE has shown the ability to reduce intraocular pressure (IOP) in the eye.
Skye's first-in-human Phase 1 trial for SBI-100 OE recently began screening activities in Australia. The company intends to initiate a Phase 2 study in patients with primary open angle glaucoma and ocular hypertension in the US in the first half of 2023.
The Phase 2 trial is intended to be a multi-center, double-masked, randomized, placebo-controlled, dose-response study assessing the ocular hypotensive efficacy, safety and tolerability of two concentrations of SBI-100 OE in patients with elevated intraocular pressure.
In this study, approximately 54 patients will be treated in both eyes twice daily over a seven-day period.
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.
Its lead program, SBI-100 OE, is focused on developing a treatment for glaucoma, the world's leading cause of irreversible blindness.
Contact the author at jon.hopkins@proactiveinvestors.com