Skye Bioscience receives positive safety review of topical cannabinoid receptor type 1 agonist after second cohort of phase 1 study

SBI-100 OE is a cannabinoid receptor type 1 (CB1R) agonist delivered topically into the eye. (Image courtesy stock.adobe.com)

Skye Bioscience, Inc. has received a positive recommendation following a pre-specified data review by the safety review committee (SRC), based on the dosing of the second cohort of 8 healthy participants of its Phase 1 study of SBI-100 Ophthalmic Emulsion (OE). According to a press release¹ from the company, the SRC has recommended that the trial continue without modification.

According to the release, SBI-100 OE is a cannabinoid receptor type 1 (CB1R) agonist delivered topically into the eye. It is a synthetic cannabinoid derivative to treat glaucoma and ocular hypertension. SBI-100 OE possesses 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 preclinical trials involving 3 different species, Skye Bioscience states “a nanoemulsion formulation of the drug applied topically to the eye resulted in enhanced therapeutic efficacy and duration of response in lowering IOP.”

According to the release, the SRC evaluated data from all 8 participants enrolled in Cohort 2 of the single ascending dose arm (SAD) of this Phase 1 study. Of the 8 participants, 6 were dosed with SBI-100 OE, while 2 were dosed with a placebo.

In this second cohort, participants were administered a single topical dose of SBI-100 OE at a concentration of 1.0%, compared to the first cohort dose concentration of 0.5%. The SRC determined that, as in Cohort 1, 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 U.S. Food and Drug Administration (FDA) gave the okay to proceed for the Investigational New Drug (IND) application for SBI-100 OE in December of last year.³ This enables Skye to initiate clinical trials in the United States, including its planned Phase 2 study in the first half of 2023.

Skye Bioscience Inc. has also retained Lexitas Pharma Services Inc. as the contract research organization (CRO) for its Phase 2a study of SBI-100 OE.²

Tu Diep, Chief Development Officer of Skye is confident in the trials moving forward and the partnership with Lexitas.

"We have a high level of confidence in Lexitas' expertise to support our Phase 2a study in the United States," said Diep. "Lexitas' strong relationships with glaucoma investigators, proven operational expertise and a commitment to high-quality data, they are the ideal partner for this important trial."

The third cohort will increase the dose of SBI-100 OE concentration from 1.0% to 2.0%. Recruitment for the third cohort of 8 participants has begun, with dosing planned for March of this year, and is being conducted by CMAX Clinical Research in Adelaide, Australia.

References:

1. Skye Bioscience receives positive safety review of SBI-100 Ophthalmic Emulsion after second cohort of phase 1 study. Press release. Skye Bioscience; February 23, 2023. Accessed February 23, 2023. https://ir.skyebioscience.com/news-events/press-releases/detail/158/skye-bioscience-receives-positive-safety-review-of-sbi-100

2. Skye Bioscience retains Lexitas Pharma Services as CRO for phase 2 trial of SBI-100 Ophthalmic Emulsion. Press release. Skye Bioscience; February 02, 2023. Accessed February 23, 2023. https://ir.skyebioscience.com/news-events/press-releases/detail/154/skye-bioscience-retains-lexitas-pharma-services-as-cro-for

3. Skye Bioscience receives FDA authorization of Investigational New Drug Application for SBI-100 OE. Press release. Skye Bioscience; December 20, 2022. Accessed February 23, 2023. https://ir.skyebioscience.com/news-events/press-releases/detail/151/skye-bioscience-receives-fda-authorization-of