Pharma Focus Europe

Skye Bioscience Initiates First-in-Human Phase 1 Clinical Trial for SBI-100

Thursday, November 17, 2022

Skye Bioscience, Inc., a pharmaceutical company developing a proprietary, synthetic cannabinoid derivative to treat glaucoma, has initiated screening for its first-in-human Phase 1 trial of SBI-100 Ophthalmic Emulsion ("SBI-100 OE"). As previously announced, this study has received all regulatory approvals to initiate in Australia and will be conducted at CMAX Clinical Research, Skye's contract clinical trial unit in Adelaide, Australia.

The primary endpoints for this randomized, double-masked, placebo-controlled study are to assess safety and tolerability of the drug in healthy volunteers. The secondary endpoint is to assess pharmacokinetics. The study will also measure changes to intraocular pressure in the eye. A total of 48 subjects will be topically administered SBI-100 OE or placebo on a single eye in single ascending dose (SAD) and multiple ascending dose (MAD) 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 placebo. Recruitment of participants for this study has begun and the first cohort is expected to be enrolled in December.

"The initiation of this first-in-human Phase 1 trial for SBI-100 OE marks an important milestone for Skye. 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," said Punit Dhillon, CEO and Chair of 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."

Since meeting regulatory requirements to begin the Phase 1 clinical study and completing clinical material production, as announced in prior news releases, Skye 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.

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