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Skye Bioscience Achieves Positive Safety Review of SBI-100 Ophthalmic Emulsion After Phase 1 First Cohort

Wednesday, February 01, 2023

Skye Bioscience, Inc., a pharmaceutical company developing a proprietary, synthetic cannabinoid derivative to treat glaucoma, has received a positive recommendation following a pre-specified data review by the safety review committee ("SRC") based on dosing of the first cohort of eight healthy participants of its Phase 1 study of SBI-100 Ophthalmic Emulsion ("OE"). The SRC has recommended that the trial continue without modification. Recruitment for the second cohort of eight participants has begun, with dosing planned for February.

The SRC is comprised of three voting members comprised of an independent medical consultant, the trial's medical monitor and the principal investigator, who serves as the chairperson. The SRC's role is to review masked safety data per cohort and provide recommendations for the trial to continue at the same dose or at a lower dose, escalate to a higher dose, or terminate the study altogether due to safety concerns. The SRC evaluated data from all eight participants enrolled in cohort 1. They determined that SBI-100 OE was well-tolerated, with no drug-related serious adverse events and only mild adverse events related to SBI-100 OE were reported.

"The results of this safety analysis of the masked data did not uncover any issues of concern," said Prof. Sepehr Shakib, Medical Director at CMAX and principal investigator of the SBI-100 Ophthalmic Emulsion Phase 1 study. "As a result, the SRC determined that the study should continue per the protocol. We are now recruiting for the second cohort of this study and look forward to working toward full enrollment of this novel study."

"We are pleased to see the first evidence in humans of a positive safety profile of SBI-100 OE," said Tu Diep, Chief Development Officer of Skye. "These results were what we anticipated but they provide additional confidence to potential participants in our Phase 1 study as we recruit for the next cohorts."

The objective for this randomized, double-masked, placebo-controlled, single and multiple ascending dose Phase 1 study is to evaluate the safety, tolerability and pharmacokinetics of SBI-100 OE. Changes in intraocular pressure will also be evaluated. In this two-part study, a total of approximately 48 subjects are divided into three single ascending dose and three multiple ascending dose cohorts. In each cohort of eight participants, six will be administered SBI-100 OE and two placebo. The SRC will evaluate the safety results after each cohort is completed.

In the first SAD cohort, participants were administered a single topical dose of SBI-100 OE at a concentration of 0.5%. Participants were subsequently monitored for safety and tolerability over three days following dose administration. In the second and third cohorts of the SAD arm, participants will receive a single dose of SBI-100 OE at 1.0% and 2.0%, respectively.

SBI-100 OE is a synthetic cannabinoid derivative that targets the CB1 receptor, which plays a key role in managing intraocular pressure associated with glaucoma. It is a novel synthetically-derived molecule formulated as an eye-drop using a propriety nanoemulsion to improve delivery into the eye. SBI-100 OE displayed favorable results in animal studies as a monotherapy and in combination with standard of care ("SOC") glaucoma drugs compared to SOC alone and other combinations. The first cohort of healthy participants in Skye's first-in-human Phase 1 clinical trial in Australia were dosed in December.

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