Skye Bioscience has retained CMAX Clinical Research (CMAX) for a Phase I clinical trial of its lead product candidate, SBI-100 Ophthalmic Emulsion (SBI-100 OE), being developed for potential treatment of glaucoma.
One of the largest trial operators in Australia specialising in early-phase trials, CMAX will aid Skye in enrolling subjects and administration of the trial drug to healthy participants.
The company noted that the trial will be carried out in a purpose-built independent trial facility of CMAX in Adelaide, Australia.
CMAX will carry out the Phase I single ascending dose (SAD) and multiple ascending dose (MAD) trial in healthy subjects to assess the safety and pharmacokinetics of SBI-100 OE under Good Clinical Practice (GCP).
The final results from this trial are anticipated in the fourth quarter of this year.
The US Food and Drug Administration, UK Medicines and Healthcare products Regulatory Agency, European Medicines Agency and Australian Therapeutic Goods Administration need GCP compliance for trial data to be completely recognised and accepted.
A synthetic prodrug formulation, SBI-100 OE is designed to enhance the therapeutic utility of a cannabinoid receptor-type 1 agonist to develop a new class of drug for treating glaucoma.
Skye Bioscience chief development officer Tu Diep said: “CMAX, along with our principal investigator, Professor Shakib, are highly capable with decades of experience in conducting first-in-human clinical trials.
“They are excellent complements to our recently selected contract research organisation for this study, Novotech. We are on track to begin enrolling subjects in the second quarter.”
SBI-100 OE was found to show reduction in intraocular pressure, a crucial risk factor in disease progression linked to glaucoma, in terms of intensity and time versus presently offered standard of care therapies, in preclinical studies.
In addition, the therapy showed characteristics that could facilitate once-daily topical application.
In March this year, the company entered an agreement under which Novotech Health will serve as contract research organisation for the upcoming Phase I trial of SBI-100 for glaucoma in Australia.