Skye Bioscience Inc (OTCQB:SKYE) said the US Food and Drug Administration (FDA) has authorized it to proceed with the Investigational New Drug (IND) application for SBI-100 Ophthalmic Emulsion (OE), a synthetic cannabinoid derivative that targets the CB1 receptor, which plays a key role in managing intraocular pressure.
The company can now initiate clinical trials in the US, including its planned Phase 2 study for primary open-angle glaucoma or ocular hypertension in the first half of 2023.
"We are pleased to receive the okay from the FDA on our IND submission, which we accomplished by year-end, as planned," Tu Diep, chief development officer of Skye said in a statement. "We have dosed the first cohort of participants in our Phase 1 trial in Australia. With our IND active, our team is advancing the manufacturing and clinical planning steps to begin our planned Phase 2 in the US. We expect to initiate Phase 2 in the first half of 2023 and report data in Q1 2024."
READ:Skye Bioscience says dosing completed of SBI-100 Ophthalmic Emulsion in first cohort of the single ascending dose part of its Phase 1 study
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 favorable results in animal studies as a monotherapy and in combination with standard-of-care (SOC) glaucoma drugs compared to SOC alone and other combinations. A first-in-human Phase 1 clinical trial in healthy participants recently started in Australia.
"Multiple scientific studies have shown that cannabinoids can reduce intraocular pressure. What was missing to create an effective medicine was a method to safely and effectively deliver a therapeutic dose into the eye.
"Based on the design of this first-ever new drug class and the nonclinical data we have achieved, we believe we have overcome the challenge of the delivery method. We look forward to a productive 2023," commented Punit Dhillon, CEO and chair of Skye.
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. The company's 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