Decorative

Clinical Trials

Pursuing clinical validation of a new class of endocannabinoid system-targeting medicines

Skye Bioscience is committed to applying best practices from drug design through manufacturing, preclinical and clinical development, and regulatory review. Our ambition is to clinically validate promising drug candidates that interact with the endocannabinoid system to potentially address various diseases.

 

Phase 1 Clinical Trial: SBI-100 Ophthalmic Emulsion

Skye’s completed first-in-human Phase 1 clinical study of SBI-100 OE was a randomized, double-masked, placebo-controlled, single ascending dose/multiple ascending dose study in 48 healthy volunteers, 36 receiving active drug. SBI-100 OE was deemed safe and well-tolerated, with no drug-related serious adverse events and treatment-related adverse events consistent with topically-applied eye treatments. No study participants dropped out due to SBI-100 OE. There was little to no exposure of THC in plasma and significantly less hyperaemia (red eyes) compared to other glaucoma therapies. Minimal discomfort common to topical ocular administration was transient and quickly resolved. The study demonstrated a 23.9% lowering of intraocular pressure in a sub-group analysis of healthy volunteers with a higher baseline IOP compared to the overall group.

Phase 2a Clinical Trial: SBI-100 Ophthalmic Emulsion for Open Angle Glaucoma and Hypertension

Skye is enrolling its Phase 2a clinical study of SBI-100 OE assessing efficacy and safety in patients with primary open-angle glaucoma (POAG) or ocular hypertension (OHT). This is a double-masked, randomized, placebo-controlled study treating approximately 54 patients with elevated intraocular pressure (IOP) diagnosed with POAG or OHT. The primary endpoints are to assess change in diurnal IOP vs placebo, and ocular and systemic safety. The study will also assess ocular hypotensive efficacy at individual time points and application comfort. Dosing is 0.5% or 1.0% concentrations of SBI-100 OE, or placebo. Patients will be treated with one drop in each eye, twice a day, in the morning and the evening (about 12 hours apart), for 14 days.

Description of Phase 2 study on ClinicalTrials.gov: NCT06144918

Phase 2a: Nimacimab

Nimacimab has a robust non preclinical data package, a completed Phase 1 study with a positive safety profile, an open Investigational New Drug file for obesity and chronic kidney disease, plus sufficient clinical drug supply to support the next planned clinical trial. Skye is planning to start a Phase 2a study in patients with obesity and chronic kidney disease in the mid-2024.