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 is conducting its first-in-human Phase 1 clinical study of SBI-100 OE in Australia. The primary endpoints for this randomized, double-masked, placebo-controlled study are to assess safety and tolerability of the drug in healthy volunteers. The secondary endpoint is to assess pharmacokinetics. The study will also measure changes to intraocular pressure in the eye. A total of 48 subjects were topically administered SBI-100 OE or placebo on a single eye in single ascending dose and multiple ascending dose arms. Eight participants were enrolled in each of six total cohorts. In each cohort, six participants were administered SBI-100 Ophthalmic Emulsion and two placebo. Enrollment and dosing has been completed with no serious adverse events recorded in any of the cohorts and Skye expects to report preliminary data in early Q4 2023.

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

Skye is preparing for its planned Phase 2a clinical study of SBI-100 OE to test for efficacy and safety in patients with glaucoma or hypertension. Skye has received authorization from the Federal Drug Administration for its investigational new drug application, enabling the Company to initiate clinical trials in the United States, and has received institutional review board approval for the Phase 2a trial sites. Skye retained Lexitas Pharma Services, a leading full-service ophthalmic-focused contract research organization, to conduct the study. Skye is completing additional preparatory steps and aims to dose the first the first Phase 2a patient in early Q4.

Phase 2a: Nimacimab

Nimacimab has a robust non preclinical data package, a completed Phase 1 study with a positive safety profile, three active Investigational New Drug files, including one for chronic kidney disease, plus sufficient clinical drug supply to support the next planned clinical trial. With these obstacles removed, Skye can progress toward a planned Phase 2a basket study for chronic kidney disease.