Skye Completes Production Of Cannabinoid Based Drug In Preparation For Glaucoma Clinical Trial

Skye Bioscience, Inc. SKYE, a pharmaceutical company developing a proprietary, synthetic cannabinoid derivative to treat glaucoma and ocular hypertension, announced that its contract manufacturer, NextPharma Oy, in Finland, has completed production of placebo and SBI-100 ophthalmic emulsion for its planned phase 2a study of glaucoma and ocular hypertension. NextPharma has also completed filling of the drug materials into strips of 10 single-use vials. Skye is completing additional logistical and preparatory steps necessary to start this study.

"We selected NextPharma as our contract manufacturer to position ourselves for eventual commercial manufacturing including drug formulation, fill and finish capabilities, and rigorous quality systems," stated Tu Diep, chief development officer. "We needed to transfer our drug production process to them and have them evolve and implement the necessary procedures to produce our drug at scale. Their expertise and our commitment to collaboration ensured that this technology transfer has gone well. I am pleased to say that while we still have a list of preparatory steps to complete, some subject to the timelines of external agencies, completion of production has reduced science and production-related risks on our path to our phase 2a study and these final steps will be readily managed by our team.

"This study, which we expect to start enrolling in the third quarter, will for the first time ever primarily focus on the efficacy of a synthetic pro-drug in human subjects targeting the CB1 receptor of the endocannabinoid system with the goal of reducing intraocular pressure of the eye," he added.

Additional steps that must be completed to enable the start of this study include a quality assurance release of the clinical product to ensure the drug product meets specification; receipt of Finland/US export/import licenses for the clinical study material; packaging and shipment of product from Finland to the US; preparation of kits for the phase 2a clinical trial subjects; US DEA approvals of the clinical trial sites; and an update of the IND to reflect the final clinical trial protocol information.

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Photo: Courtesy of Skye Bioscience

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