Skye Bioscience Inc (OTCQB:SKYE) said it has been advised by its contract manufacturer that it has completed the production of SBI-100 Ophthalmic Emulsion (SBI-100 OE) for Skye's phase one clinical trial as a treatment for glaucoma, the world's leading cause of irreversible blindness.
The final drug product will be released and available for clinical use in October, following receipt of acceptable results from quality and analytical testing, according to San Diego-based Skye Bio.
Skye Bio CEO Punit Dhillon said the company is pleased to complete this step toward enrolling in its first in-human study using the drug.
READ: Skye Bioscience says Emerald Health Therapeutics shareholders approve integration plan of arrangement; gets regulatory approval to begin first-in-human clinical study
"Our team is scheduled to conduct our clinical site initiation in the second week of October to train staff and investigators of our clinical partner, CMAX, in Australia. Following site initiation and release of SBI-100 OE drug product, we expect dosing in subjects to begin in November," Dhillon said in a statement.
Increased intraocular pressure (IOP) is a key risk factor in the progression of glaucoma. The first observations that consuming cannabis lowered IOP in humans took place in the early 1970s, which led to a significant amount of research on the effects of cannabinoids in the eye, according to Skye Bio.
Independent studies demonstrated that activation of the cannabinoid receptor-type 1 (CB1R) in ocular tissue mediates IOP-lowering. However, no cannabinoid-related drug has been approved for clinical use in the eye due primarily to the shortcomings of current delivery methods of CB1R agonists to the eye in a therapeutically beneficial dose, the company said.
When cannabinoids are administered systemically, they can lower IOP but also result in undesirable psychotropic effects. Also, extracted natural cannabinoids delivered topically as an eye drop do not penetrate ocular tissue well enough to effectively lower IOP. This is likely due to the lipophilic, or oily, properties of natural cannabinoids and the aqueous, or watery, surface of the eye.
To address these challenges, Skye said it developed SBI-100 OE, a proprietary, synthetic cannabinoid derivative possessing a novel molecular structure and formulation that was designed to enable better penetration of ocular tissue and effective topical delivery of a CB1R agonist.
In preclinical studies involving three different species, a nanoemulsion formulation of the drug applied topically to the eye resulted in enhanced therapeutic efficacy and duration of response in lowering IOP, the company said.
These studies also demonstrated advantages compared to today's standard of care and, if clinically validated in subsequent efficacy studies, may provide a new class of medicine for glaucoma, according to Skye Bio.
Skye Bioscience is a pharmaceutical company developing proprietary cannabinoid derivatives to treat diseases with significant unmet needs.
Contact the author at susie@proactiveinvestors.com