Skye Bioscience says Phase 2a trial of SBI-100 OE did not meet primary endpoint

Skye Bioscience announced that its Phase 2a clinical trial of SBI-100 Ophthalmic Emulsion in patients with primary open-angle glaucoma or ocular hypertension did not meet its primary endpoint for lowering intraocular pressure. Skye intends to discontinue clinical development and spending related to SBI-100 OE and any R&D associated with SBI-100, including its ophthalmology pipeline, and direct all clinical development resources to its metabolic program, extending its operating runway into 2027. Skye’s Phase 2 obesity clinical trial for its differentiated CB1 inhibitor, Nimacimab, is expected to begin dosing in Q3 2024. In this Phase 2a double-masked, randomized, placebo-controlled trial of SBI-100 OE, 56 patients with elevated IOP diagnosed with POAG or OHT 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 study did not achieve a statistically significant improvement in IOP over placebo. The drug was safe and all treated patients completed the study with no early discontinuations due to adverse events.