Skye’s cannabinoid-derived glaucoma drug progresses thanks to CRO

Australian clinical research organization (CRO) CMAX Clinical Research has dosed a second cohort in a trial of cannabinoid-based glaucoma drug being developed by Skye Bioscience.

The Adelaide CRO administered a 1.0% concentration of the glaucoma hypertension drug candidate – known as SBI-1001 – to healthy volunteers in the Phase I trial last week after a positive recommendation from a safety review committee (SRC).

The committee looked at data from volunteers who received a 0.5% dose of the drug and determined that SBI-100 OE was well-tolerated, with no drug-related serious adverse events observed. Only mild adverse events were reported.

According to Skye, “the SRC recommended that the trial continue without modification.”

It added that “participants in the second cohort were also monitored for safety and tolerability over three days following dose administration, and the SRC will review this data as per the study protocol.

“Skye expects to enroll the SAD [single ascending dose] arm’s third and last cohort in March, in which participants will receive a single dose of SBI-100 OE at 2.0%.”

SBI-100 OE is a synthetically derived molecule formulated as an eye-drop using a propriety nanoemulsion to improve delivery into the eye. SBI-100 OE targets the CB1 receptor, which plays a key role in managing intraocular pressure associated with glaucoma.

New CRO

The news comes just days after Skye announced it had hired North Carolina-based Lexitas Pharma Services to run later stage trials of the drug.

At the time Skye cited the CRO’s experience in both anterior and posterior segments of ophthalmology, including glaucoma as key to winning it the contract.

Company chief development officer Tu Diep said “We have a high level of confidence in Lexitas’ expertise to support our Phase IIa study in the United States.

“Lexitas’ strong relationships with glaucoma investigators, proven operational expertise and a commitment to high-quality data, they are the ideal partner for this important trial.”

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