SBI-100 is a cannabinoid receptor type 1 (CB1R) agonist administered topically onto the eye to reduce IOP and treat glaucoma.
Skye Bioscience announced it has completed dosing of the third and final cohort of the multiple ascending dose (MAD) arm and planned enrollment of 48 subjects in its phase 1 clinical trial of SBI-100 Ophthalmic Emulsion (OE).
In a press release from the company,1 SBI-100 is described as a “cannabinoid receptor type 1 (CB1R) agonist administered topically onto the eye” for the treatment of glaucoma.
The company stated the objective of the Phase 1, randomized, double-masked, placebo-controlled study is to “evaluate the safety, tolerability and pharmacokinetics of SBI-100 OE with different dosing regimens,” with changes in IOP also being measured.
The trial was organized with participants randomized into a single ascending dose (SAD) arm or MAD arm, with 3 cohorts per arm and 8 participants per cohort. SBI-100 OE was administered topically in 1 eye at ascending dose concentrations of 0.5%, 1.0% and 2.0% in the respective cohorts of the two arms, according to the company.
Skye Bioscience reported in the completed SAD and the first 2 cohorts of the MAD arm, “SBI-100 OE was well-tolerated, with no drug-related serious adverse events and only mild and moderate adverse events.”
Skye stated the company plans on releasing the preliminary data report from the trial in Q3 of 2023.