Skye Bioscience Inc (OTCQB:SKYE) said it has started screening for its first-in-human Phase 1 trial of SBI-100 Ophthalmic Emulsion (SBI-100 OE), a proprietary, synthetic cannabinoid derivative intended to treat glaucoma.
San Diego-based Skye said this study has received all regulatory approvals to initiate in Australia and that it will be conducted at CMAX Clinical Research, the company’s contract clinical trial unit in Adelaide, Australia.
The biopharmaceutical company said the primary goal of this randomized, double-masked, placebo-controlled study is to assess the safety and tolerability of the drug in healthy volunteers. The secondary goal is to assess the pharmacokinetics. The study will also measure changes to intraocular pressure in the eye, the company added.
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Skye CEO Punit Dhillon said this marks an important milestone for the company.
"It is also a milestone for the pharmaceutical industry since this is the first CB1 receptor agonist eye-drop entering into human studies. We have been finalizing the last steps to start enrollment and are now counting down to dosing the first cohort of study participants," Dhillon said in a statement.
A total of 48 subjects will be topically administered SBI-100 OE or placebo on a single eye in a single ascending dose and multiple ascending dose arms. Eight participants will be enrolled in each of six total cohorts. In each cohort, six participants will be administered SBI-100 Ophthalmic Emulsion and two will receive a placebo. Recruitment of participants for this study has begun and the first cohort should be enrolled in December, according to Skye.
"Our aim is to potentially offer patients with glaucoma a treatment alternative with improved outcomes and we are pleased to initiate our first clinical study in pursuit of that goal. The data obtained through this Phase 1 trial will be important to our future development plans for this program," said Dhillon.
Since meeting regulatory requirements to begin the Phase 1 clinical study and completing clinical material production, Skye said it has worked closely with its contract manufacturers, DEA and other Australian regulatory authorities to ensure the appropriate permits were obtained to legally ship SBI-100 OE internationally for clinical trial purposes.
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 the company.
Skye said it developed SBI-100 OE, a proprietary, synthetic cannabinoid derivative possessing a novel molecular structure and formulation that was rationally designed to enable better penetration of ocular tissue and effective topical delivery of a CB1R agonist.
In pre-clinical studies involving three different species, a nano-emulsion formulation of the drug applied topically to the eye resulted in enhanced therapeutic efficacy and duration of response in lowering IOP. These studies also demonstrated advantages compared to today's standard of care and, if clinically validated in subsequent efficacy studies, may provide a suitable therapeutic window to be a new class of medicine for glaucoma, according to Skye.
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