Skye Bioscience, Inc. SKYE, a pharmaceutical company developing a proprietary, synthetic cannabinoid derivative to treat glaucoma, reported that the human research ethics committee in Australia has approved the initiation of the multiple ascending dose (“MAD”) arm of Skye’s phase 1 study of SBI-100 ophthalmic emulsion. Skye expects to dose the first MAD cohort in April.
In a similar fashion to the single ascending dose arm, each of the three MAD cohorts will consist of eight healthy participants, six to be randomized to SBI-100 OE and two randomized to placebo. Participants receiving SBI-100 OE will receive drug concentrations of 0.5%, 1.0%, and 2.0% per respective cohort. Each participant in the MAD arm will be administered a topical dose of SBI-100 OE or placebo twice a day for five consecutive days and monitored for safety for approximately five days after the last dose administration. This differs from SAD’s regimen of a single treatment followed by three days of safety monitoring.
In the SAD arm, 18 of 24 total participants across the three cohorts were dosed with SBI-100 OE. The study’s safety review committee completed its review of the first two cohorts and determined that the drug was well-tolerated, with no drug-related serious adverse events and expected mild to moderate adverse events. During the review of cohort two, the safety review committee also agreed to the advancement of the study into the MAD arm. Although MAD cohort 1 has been approved by the safety review committee, the committee will meet and perform a comprehensive review of all single ascending dose data.
“With human research ethics committee approval of our submission to advance our phase 1 study into the multiple ascending dose arm, we are now lined up to start dosing in April the fourth of six total cohorts in this study of our novel synthetic cannabinoid derivative, SBI-100 ophthalmic emulsion,” stated Punit Dhillon, CEO and chair of Skye.
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