Business
Skye Bioscience Treats First Patient in Glaucoma Phase 2 Study of SBI-100 Ophthalmic Emulsion
SBI-100 Ophthalmic Emulsion, a CB1 agonist/activator delivered as a topical eye drop, was developed to treat patients with elevated intraocular pressurePhase
About this update from Skye Bioscience, Inc.
[{"type":"text","content":"SBI-100 Ophthalmic Emulsion, a CB1 agonist/activator delivered as a topical eye drop, was developed to treat patients with elevated intraocular pressurePhase 2 study evaluating efficacy and safety using two concentrations of SBI-100 OE vs. placebo, dosing twice a day for 14 daysAnalysis of IOP data from 50% of patients enrolled in Phase 2 study to be performed in Q1 2024 SAN DIEGO, Nov. 28, 2023 (GLOBE NEWSWIRE) -- Skye Bioscience, Inc. (OTCQB: SKYE) (\"Skye\" or the \"Company\"), a pharmaceutical company developing drugs targeting the endocannabinoid system, focusing on glaucoma and metabolic conditions, has treated the first patient in its Phase 2 clinical trial evaluating SBI-100 Ophthalmic Emulsion’s (“OE”) ability to lower intraocular pressure (“IOP”), safety and relevant biomarkers, in patients with primary open-angle glaucoma (\"POAG\") or ocular hypertension (\"OHT\"). SBI-100 OE is a synthetic prodrug of tetrahydrocannabinol (“THC”) that is able to bind and activate CB1 receptors in key ocular tissues. “Skye’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,” said Punit Dhillon, Skye’s CEO and Chairman. “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. Following our encouraging Phase 1 results, we look forward to assessing initial Phase 2 IOP results in Q1 2024.” SBI-100 Ophthalmic Emulsion Phase 2 Study Design Double-masked, randomized, placebo-controlled study treating approximately 54 patients with elevated intraocular pressure (between 21mmHg and 36mmHg) diagnosed with POAG or OHT.Primary endpoints: assess change in diurnal IOP vs placebo, and ocular and systemic safety.Secondary endpoints: assess ocular hypotensive efficacy at individual time points and application comfort.Dosing: 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.Des...