Skye Bioscience, Inc. SKYE , a pharmaceutical company developing a proprietary, synthetic cannabinoid derivative to treat glaucoma, has selected NextPharma as its contract manufacturing organization (“CMO”) for its Phase 2 clinical trial material.
“As is typical with pharmaceutical drug production, early and late stage production of clinical trial materials are usually undertaken by CMOs with different skill sets. Skye completed an extensive search and due diligence process to choose an ideal CMO to produce SBI-100 Ophthalmic Emulsion for its next stages of development and we are pleased that NextPharma has partnered with us on this project,” stated Punit Dhillon, CEO and chair of Skye. “Apart from their broad expertise in manufacturing commercially-approved drugs for major pharmaceutical clients, NextPharma is also experienced in handling controlled substances, which will be valuable in serving Skye’s needs.”
“During our pre-Investigational New Drug (“IND”) meeting with the FDA’s Division of Ophthalmology, we confirmed that our nonclinical safety package would be sufficient to support a Phase 2 study under our first US IND,” added Dhillon. “Our plan is to file our IND for a US Phase 2 clinical study in the fourth quarter of this year. We expect to start the Phase 2 study in the first half of 2023 and report final data by year-end 2023.”
About SBI-100 Ophthalmic Emulsion
Increased intraocular pressure (IOP) is a key risk factor in the progression of glaucoma. The first observations that consuming cannabis lowered IOP in humans took place in the early 1970s, which led to a significant amount of research on the effects of cannabinoids in the eye. Independent studies demonstrated that activation of the cannabinoid receptor-type 1 (CB1R) in ocular tissue mediates IOP-lowering.
However, no cannabinoid-related drug has been approved for clinical use in the eye due primarily to the shortcomings of current delivery methods of CB1R agonists to the eye in a therapeutically beneficial dose. When cannabinoids are administered systemically they can lower IOP but also result in undesirable psychotropic effects. Alternatively, extracted natural cannabinoids delivered topically as an eye drop do not penetrate ocular tissue well enough to effectively lower IOP due to the lipophilic, or oily, properties of natural cannabinoids and the aqueous, or watery, surface of the eye.
To address these challenges, Skye developed SBI-100 OE, a proprietary, synthetic cannabinoid derivative possessing 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 studies involving three different species, a nanoemulsion formulation of the drug applied topically to the eye resulted in enhanced therapeutic efficacy and duration of response in lowering IOP. Importantly these studies also demonstrated advantages compared to today’s standard of care and, if clinically validated in subsequent efficacy studies, may provide a suitable therapeutic window to be a new class of medicine for glaucoma.
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