California-based Skye Bioscience completed dosing its third cohort of eight healthy participants in its phase 1 clinical trial of SBI-100, a synthetic cannabinoid derivative designed to treat glaucoma and ocular hypertension. The move was given the go-ahead following a positive recommendation from the study's safety review committee (SRC) which assessed data from the trial’s second cohort. The SRC also recommended the trial advance into the multiple ascending-dose (MAD) part of the study.
The objective of the randomised, double-masked, placebo-controlled study, involving 48 participants, is to evaluate the safety, tolerability and pharmacokinetics of SBI-100 ophthalmic emulsion (OE), said the company, adding changes in intraocular pressure will also be evaluated.
According to Skye, SBI-100 was developed to allow better penetration of ocular tissue and avoid the undesirable psychotropic effects of systematic administration of natural cannabinoids. “SBI-100 OE possesses a novel molecular structure and nanoemulsion formulation designed to enable effective topical delivery and better penetration of a CB1R agonist into ocular tissue. In preclinical studies involving three different species, the drug resulted in enhanced therapeutic efficacy and duration of response in lowering IOP, comparing favourably to the standard of care for treating glaucoma.”
