Skye Bioscience Inc (OTCQB:SKYE) has entered into an agreement with Lexitas Pharma Services Inc, a full-service ophthalmic-focused contract research organization (CRO) for its planned Phase 2a study of SBI-100 OE for glaucoma and hypertension.
"We have a high level of confidence in Lexitas' expertise to support our Phase 2a study in the United States," Skye chief development officer Tu Diep said in a statement. "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."
SBI-100 OE is formulated as an eye drop using a propriety nanoemulsion to improve delivery into the eye, the company said. It targets the CB1 receptor, which plays a key role in managing intraocular pressure associated with glaucoma.
READ: Skye Bioscience gets positive safety review of SBI-100 OE after phase 1 first cohort
The study is expected to begin in the US in the first half of 2023.
Previously, SBI-100 OE has shown favorable results in animal studies as a monotherapy and in combination with standard-of-care (SOC) glaucoma drugs compared to SOC alone and other combinations. The first cohort of healthy participants in Skye's first-in-human Phase 1 clinical trial in Australia was dosed in December.
Skye Bioscience is a pharmaceutical company working to unlock the potential of cannabinoids through the development of its proprietary cannabinoid derivatives to treat diseases with significant unmet needs. The company's lead program, SBI-100 OE, is focused on developing a treatment for glaucoma, the world's leading cause of irreversible blindness.
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