Skye Bioscience inc (OTCQB:SKYE) said it has hired experienced Australian clinical trial operator CMAX to run its phase 1 study of lead candidate SBI-100 OE to treat glaucoma in Adelaide with final data expected in the fourth quarter this year.
CMAX will conduct Skye's first-in-human single ascending dose (SAD) and multiple ascending dose (MAD) phase 1 study in healthy volunteers, evaluating safety and pharmacokinetics of SBI-100 OE under good clinical practice (GCP).
"CMAX, along with our principal investigator, Professor Shakib, are highly capable with decades of experience in conducting first-in-human clinical trials," said Tu Diep, the chief development officer of Skye, in a statement.
"They are excellent complements to our recently selected contract research organization for this study, Novotech. We are on track to begin enrolling subjects in the second quarter," added Diep.
READ: Skye Bioscience partners with Novatech Heath Holdings for Phase I trial of glaucoma drug candidate
Dr Shakib, also consulting medical director of CMAX, added: "We have submitted the protocol for this study to the Human Research Ethics Committee (HREC).
"We are working closely with the Skye team to prepare for enrollment of our first participants in this study upon approval from HREC and filing of the Clinical Trial Notification to the Australian Therapeutics Goods Administration."
Skye is actively pursuing a product and clinical development plan to unlock the full potential of cannabinoids for glaucoma and diseases with significant unmet needs.
Its SBI-100 Ophthalmic Emulsion is a proprietary formulation of a synthetic prodrug rationally designed with the goal of improving the therapeutic utility of a cannabinoid receptor-type 1 agonist in order to create a new class of drug to treat glaucoma.
In preclinical studies, it demonstrated superior lowering of intraocular pressure, a key risk factor in disease progression related to glaucoma, compared to currently "standard of care" drugs. It has also shown characteristics that may enable a once-a-day topical application.
Contact the writer at giles@proactiveinvestors.com