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Skye Bioscience, Inc. (SKYED) is a pharmaceutical company dedicated to developing cannabinoid-based therapies targeting the endocannabinoid system, specifically focusing on the modulation of the CB1 receptor. Their flagship product, SBI-100 Ophthalmic Emulsion (OE), aims to address diseases like glaucoma and metabolic conditions by lowering intraocular pressure (IOP). Skye has received approval from the U.S. DEA to conduct clinical trials for SBI-100 OE across multiple sites, with plans to enroll patients in Q4 and interim data analysis expected in Q1 2024. In addition, Skye is working on nimacimab, a negative allosteric modulating antibody that inhibits peripheral CB1, showing promising results in cardio-metabolic-related indications.
FAQ
What is the market cap of Skye Bioscience (skyed)?
The market cap of Skye Bioscience (skyed) is approximately 10.9M.
What is Skye Bioscience, Inc. focused on?
Skye is focused on developing cannabinoid-based therapies targeting the endocannabinoid system.
What is SBI-100 Ophthalmic Emulsion?
SBI-100 OE is a prodrug that converts into THC, aimed at lowering intraocular pressure associated with glaucoma.
What is nimacimab?
Nimacimab is a negative allosteric modulating antibody that inhibits peripheral CB1, showing promise in cardio-metabolic-related indications.
What recent approval did Skye receive?
Skye received approval from the U.S. DEA to conduct clinical trials for SBI-100 OE across multiple sites.
When is the enrollment of patients expected for SBI-100 OE trials?
Patient enrollment for SBI-100 OE trials is planned to begin in Q4 with interim data analysis expected in Q1 2024.
What is the primary objective of the clinical study SBI-100-201?
The primary objective is to evaluate the safety and effectiveness of two dose levels of SBI-100 OE when compared to placebo in patients with elevated intraocular pressure.
What is the unique feature of SBI-100 OE?
SBI-100 OE possesses a novel molecular structure and nanoemulsion formulation designed for effective topical delivery and better penetration of a CB1R agonist into ocular tissue.
How does Skye plan to progress with nimacimab?
Skye plans to start a Phase 2 cardio-metabolic-related indication study for nimacimab in Q1 2024.
What is the significance of Skye's recent financing?
The recent August financing fully funded the Phase 2a study of SBI-100 OE and is expected to lead to the first data relatively quickly.
What are the safety considerations for SBI-100 OE?
Safety data from the Phase 1 study of SBI-100 OE in healthy volunteers will provide an evaluation of specific topical adverse side effects and systemic exposure to THC.