Skye Bioscience doses final patient in phase 1 clinical trial of SBI-100 ophthalmic emulsion

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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.

References:

1. Skye Bioscience Completes Enrollment of Phase 1 Clinical Trial of Novel CB1R Agonist, SBI-100 Ophthalmic Emulsion. Press Release. Skye Bioscience; June 12, 2023. Accessed June 12, 2023. https://www.newsfilecorp.