SBI-100 OE

SBI-100 Ophthalmic Emulsion: Termination of Program

SBI-100 Ophthalmic Emulsion (OE), a novel synthetic prodrug of tetrahydrocannabinol (THC), is a proprietary topical formulation that Skye was developing as an intraocular pressure (IOP)-lowering treatment for glaucoma and ocular hypertension. In June 2024 Skye terminated this program.

In nonclinical studies, SBI-100 OE demonstrated a greater and longer-lasting reduction of IOP compared to leading commercialized drugs in the glaucoma market. In the first human study (Phase 1) of SBI-100 OE, the drug was deemed safe and well-tolerated, there was little to no exposure of THC in plasma, and little to no hyperemia was observed. Minimal discomfort common to topical ocular administration was transient and quickly resolved.

In December 2023, Skye launched a double-masked, randomized, placebo-controlled Phase 2a clinical trial of SBI-100 OE (ClinicalTrials.gov: NCT06144918). In this trial, 56 patients with elevated IOP diagnosed with primary open-angle glaucoma or ocular hypertension received dosing of 1.0% or 0.5% concentrations of SBI-100 OE, or placebo, consisting of one drop in each eye, twice a day, for 14 days. The primary endpoint was to assess change in diurnal intraocular pressure in the treated arms vs. placebo. The drug was safe and all treated patients completed the study with no early discontinuations due to adverse events, however, the study did not achieve a statistically significant improvement in IOP over placebo.

Skye discontinued clinical development and spending related to SBI-100 OE and any R&D associated with SBI-100, including its ophthalmology pipeline, and has directed all clinical development resources to its metabolic program.