Skye Bioscience, Inc. has received a positive recommendation following a pre-specified data review by the safety review committee (SRC) based on dosing of the second cohort of eight healthy participants of its phase 1 study of SBI-100 ophthalmic rmulsion (OE). The SRC has recommended that the trial continue without modification. Recruitment for the third cohort of eight participants has begun, with dosing planned for March.
The SRC evaluated data from all eight participants (six dosed with SBI-100 OE and two dosed with placebo) enrolled in cohort 2 of the single ascending dose arm (SAD) of this phase 1 study. In this cohort, participants were administered a single topical dose of SBI-100 OE at a concentration of 1.0%, compared to a concentration of 0.5% in the first cohort.
Participants were monitored for safety and tolerability over three days following dose administration. The SRC determined that, as in cohort 1, SBI-100 OE was well-tolerated, with no drug-related serious adverse events and only mild adverse events related to SBI-100 OE were reported.
In the third cohort, the dose of SBI-100 OE will increase to a concentration of 2.0%.
The SRC also agreed to the initiation of the first cohort of the second arm of this phase 1 study, which is the multiple ascending dose (MAD) arm. This agreement will be noted in the SRC summary which will be included in Skye's human ethics review committee (HREC) submission to obtain approval to initiate the MAD arm of the study.