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 will be topically administered SBI-100 OE or placebo on a single eye in single ascending dose and multiple ascending dose arms. Eight participants will be enrolled in each of six total cohorts. In each cohort, six participants will be administered SBI-100 Ophthalmic Emulsion and two will receive placebo.

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 saftey 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. Skye also retained Lexitas Pharma Services, a leading full-service ophthalmic-focused contract research organization, to conduct the study.

SBI-100 Ophthalmic Emulsion has a novel product profile

SBI-100 Ophthalmic Emulsion is a proprietary formulation of a synthetic prodrug rationally designed to improve the ocular solubility and permeability of a cannabinoid receptor-type 1 agonist being developed to treat glaucoma.