Skye Bioscience, Inc. has received a positive recommendation from the safety review committee (SRC) after a pre-specified data review for the dosing of a second cohort of its phase 1 study for SBI-100 ophthalmic emulsion (OE).
Give me a quick rundown Skye and SBI-100 OE.
Skye Bioscience is a pharmaceutical company that is developing a proprietary, synthetic cannabinoid designed to treat various diseases with unmet needs. SBI-100 OE is Skye’s lead program undergoing evaluation as a potential treatment for glaucoma.
How about SBI-100 OE?
SBI-100 is a prodrug of tetrahydrocannabinol (THC). As a new, synthetically-derived molecule, it’s formulated as an eye drop that uses a nanoemulsion for improving medicine delivery into the eye. The drug is designed to target the CB1 receptor, which can modulate intraocular pressure (IOP).
Tell me more about this review
The SRC assessed data from eight participants enrolled in Cohort 2 of the single-ascending dose arm from the phase 1 study. Six patients were dosed with SB-100 and two were dosed with a placebo. The SB-100 dosed patients were administered a single topical dose with a 1% concentration (a 0.5% concentrated dose was administered in the first cohort).
All patients were observed for 3 days post-dose administration for safety and tolerability.
What did they determine?
The SRC concluded that, similar to Cohort 1, SB-100 was found to be well-tolerated in the second cohort. No drug-related serious adverse events (AEs) were reported—only mild AEs.
The committee also agreed to initiate the second arm of the first cohort in the phase 1 study utilizing a multiple-ascending dose (MAD) arm.
With the SRC’s approval, Skye has begun recruiting eight participants for the third (and last) cohort of this phase 1 study. The company plans on beginning dosing in March, with the concentrated dose of SBI-100 increased to 2%.
Anything else to know?
Skye also recently received approval from a central institutional review board (IRB) for a phase 2 clinical trial of SBI-100 for the treatment of primary open-angle glaucoma or ocular hypertension patients.