Pharma Focus Asia

Skye Bioscience Receives FDA Authorization of Investigational New Drug Application for SBI-100 OE

Wednesday, December 21, 2022

Skye Bioscience, Inc., a pharmaceutical company developing a proprietary, synthetic cannabinoid derivative to treat glaucoma, today announced that the U.S. Food and Drug Administration ("FDA") has given the okay to proceed for the Investigational New Drug ("IND") application for SBI-100 Ophthalmic Emulsion ("OE"). This enables the Company to initiate clinical trials in the United States, including its planned Phase 2 study for primary open angle glaucoma or ocular hypertension in the first half of 2023.

SBI-100 OE is a synthetic cannabinoid derivative that targets the CB1 receptor, which plays a key role in managing IOP. It 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.

"We are pleased to receive the okay from the FDA on our IND submission, which we accomplished by year end, as planned," said Tu Diep, Chief Development Officer of Skye. "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."

Punit Dhillon, CEO and Chair of Skye, said, "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."

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