Pharmaceutics International, Inc. (Pii) announced a first-in-human Phase I clinical study for Skye Bioscience, Inc.'s proprietary, synthetic cannabinoid derivative, SBI-100 Ophthalmic Emulsion (OE), which has been designed to advance a new mechanism of action with potential as a treatment for glaucoma. Increased intraocular pressure (IOP) is a key risk factor in the progression of glaucoma, an eye disease that leads to blindness. Independent studies have demonstrated that activating the cannabinoid receptor-type 1 (CB1R) in ocular tissue mediates IOP-lowering.

Skye's synthetic cannabinoid derivative, a molecule licensed from the University of Mississippi, possesses a novel molecular structure and formulation that was rationally designed to enable effective topical delivery and better penetration of ocular tissue of a CB1R agonist. In preclinical studies involving three different species, a nanoemulsion formulation of Skye's drug applied topically to the eye was effective in lowering IOP and compared favorably to today's standard of care for lowering IOP. Skye initiated its first-in-human Phase 1 clinical study of SBI-100 OE in Australia in November and dosed the first cohort of healthy participants in December.

The objective for this randomized, double-masked, placebo-controlled, single- and multiple-ascending dose study is to evaluate the safety, tolerability, and pharmacokinetics of SBI-100 OE. Changes in intraocular pressure will also be evaluated. The study will enroll approximately 48 participants.

Skye expects to complete enrollment of the study and report data in 2023. Skye is also working to initiate a U.S.-based Phase 2 study in participants with primary open-angle glaucoma and ocular hypertension in the first half of 2023. Pii manufactured both placebo and active batches of SBI-100 OE for clinical trial materials (CTMs) in the Phase 1 study.