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Skye Bioscience treats first patient in glaucoma Phase 2 study of SBI-100 ophthalmic emulsion


The Phase 2 study is evaluating the efficacy and safety using 2 concentrations of SBI-100 OE vs. placebo, dosing twice a day for 14 days.

(Image Credit: AdobeStock/Akarat Phasura)

(Image Credit: AdobeStock/Akarat Phasura)

Skye Bioscience Inc announced it has treated the first patient in its Phase 2 clinical trial (NCT06144918) evaluating SBI-100 ophthalmic emulsion’s (OE) ability to lower IOP, safety and relevant biomarkers, in patients with primary open-angle glaucoma (POAG) or ocular hypertension (OHT).

According to the company’s news release, SBI-100 OE is a synthetic prodrug of tetrahydrocannabinol (THC) that is able to bind and activate CB1 receptors in key ocular tissues.1

SBI-100 OE is a synthetic THC prodrug that can cross the corneal membrane, where it is converted into THC. The company noted this active form of SBI-100 OE is able to bind and activate CB1 receptors in key ocular tissues, which may help to lower IOP in patients suffering from glaucoma and ocular hypertension.1

Punit Dhillon, Skye’s CEO and chairman, noted in the news release the company’s clinical pipeline targets the endocannabinoid system, which has seen growing development and M&A attention.

“We are advancing the next generation of investigational drugs targeting the endocannabinoid system’s CB1 receptor,” Dhillon said in the release. “Key opinion leaders have indicated that there is a need for an alternative class of glaucoma medicine to serve patients that fail approved treatments and that potentially offers an improved safety profile. SBI-100 OE represents an opportunity to develop a first-in-class alternative with differentiated therapeutic characteristics.”

Dhillon added that on the heels of the company’s encouraging Phase 1 results, it is looking forward to assessing initial Phase 2 IOP results in Q1 of 2024.

SBI-100 ophthalmic emulsion Phase 2 study design

The study is a double-masked, randomized, placebo-controlled study treating approximately 54 patients with elevated intraocular pressure (between 21mmHg and 36mmHg) diagnosed with POAG or OHT. The primary endpoints will assess change in diurnal IOP vs placebo, and ocular and systemic safety.

The company noted that secondary endpoints will assess ocular hypotensive efficacy at individual time points and application comfort.

The study’s dosing is 0.5% or 1.0% concentrations of SBI-100 OE, or placebo. Patients will be treated with one drop in each eye, twice a day, in the morning and the evening (about 12 hours apart), for 14 days. NCT06144918

“We have long been aware of THC’s ability to lower intraocular pressure, however, the true capabilities were confounded by the psychotropic effects of inhaled/ingested delivery. Localized ocular delivery via topical drop enables optimal evaluation with less risk of the systemic (psychotropic) effect, allowing for concise assessment of the IOP lowering potential,” David Wirta, MD, a principal investigator of this study, said in the news release. “This Phase 2 study provides an avenue to confirm IOP-lowering ability and advance the potential for SBI-100 OE in treating ophthalmic disorders.”

SBI-100 OE Phase 1 trial results

In October 2023, Skye reported data from its first clinical study of SBI-100 OE, with the following highlights:1

  • SBI-100 OE was deemed safe, well-tolerated, and no serious adverse events were reported (drug related and non-drug related).
  • No participants dropped out due to SBI-100. Reported adverse events were consistent with topically applied eye treatments.
  • Discomfort/pain after drop instillation was the most commonly reported adverse event, but was transient and resolved in less than 15 minutes.
  • SBI-100 was detected in the blood, consistent with exposure dose concentration, however, none of the active ingredient (THC) and minimum amounts of the psychoactive metabolite (11-OH-THC) were detected. The lack of detection supports minimal systemic side effects.
  • Low rate of hyperaemia (red eyes) of 8.4% compared to other leading classes of glaucoma drugs.
  • Mean reduction of intraocular pressure of 23.9% in subset of healthy volunteers with higher baseline IOP (> 17 mm Hg)
  1. Inc SB. Skye Bioscience Treats First Patient in Glaucoma Phase 2 Study of SBI-100 Ophthalmic Emulsion. GlobeNewswire News Room. Published November 28, 2023. Accessed November 28, 2023. https://www.globenewswire.com/news-release/2023/11/28/2786801/0/en/Skye-Bioscience-Treats-First-Patient-in-Glaucoma-Phase-2-Study-of-SBI-100-Ophthalmic-Emulsion.html
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