Envisioning a new future for the treatment of disease with significant unmet needs.
At Skye Bioscience, we are focused on the development of novel cannabinoid-based therapies with strong clinical and commercial differentiation for the treatment of glaucoma and other diseases with significant unmet needs.
Tapping into a world of potential
A vital aspect of how the body functions depends on the endocannabinoid system (ECS), which sends chemical messages and triggers biological actions critical to overall health.
Its importance in human physiology as a modulator of key system functions in the body has been well-documented in many peer-reviewed scientific publications, representing an attractive and validated target for pharmacological intervention.
Recent approvals of cannabinoid-based therapies have only scratched the surface of the potential of how modulation of the ECS can impact health. Skye is leading the way in exploring and advancing this burgeoning area of medicine.
Our Novel Approach
Explore how we’re transforming groundbreaking research into scientifically and commercially differentiated medicines
Through the application of rational drug design, our biochemically engineered cannabinoid-derived molecules have demonstrated enhanced pharmacological attributes capable of providing optimized efficacy and safety compared to natural cannabinoids as well as approved commercialized therapies.
Our technology represents a refined, scientific approach to truly realize the pharmaceutical potential of cannabinoids to transform the treatment of diseases with significant unmet needs.
SBI-100 Ophthalmic Emulsion
Our lead candidate, SBI-100 ophthalmic emulsion, a proprietary prodrug of tetrahydrocannabinol (THC), is a topical formulation under development for the treatment of glaucoma and ocular hypertension (OHT).
Previous US government studies in humans discovered that THC was able to reduce intraocular pressure (IOP), which is in part responsible for the crush-like injury to the cells of the optic nerve that can eventually result in blindness. Additional preclinical studies have shown the potential for THC to also provide neuroprotective benefit, which may be especially important to patients with glaucoma who are experiencing disease progression with normal IOP levels.
One of the major drawbacks of previous studies of the use of THC for glaucoma was that they relied on inhalation or ingestion of THC. These systemic routes of drug administration cause negative side effects like psychotropic effects and potentially decreasing blood pressure , which resulted in the American Academy of Opthamology determining that the adverse effects of systemic cannabis administration/consumption outweighed its therapeutic benefit.
At Skye Bioscience, we chemically modify THC to create a unique synthetic molecule with the intent to safely realize the known positive effects of THC. Our molecule enables enhanced local delivery in the eye, reduced systemic side effects, and the potential for neuroprotection for the treatment of ocular diseases.
SBI-100 ophthalmic emulsion for the treatment of glaucoma
Glaucoma is a group of eye diseases that can cause vision loss and blindness by damaging a nerve in the back of the eye called the optic nerve. Damage to the optic nerve is caused by increased intraocular pressure (IOP) due to improper drainage and/or overproduction of fluid in the eye.
According to the American Academy of Ophthalmology, glaucoma affects over 75 million people worldwide and is the leading cause of blindness in adults aged 60 and older.
Current therapies can lower IOP but progressive tolerance requires switching or combining drugs. They do NOT provide neuroprotective capabilities.
In preclinical studies, Skye’s SBI-100 ophthalmic emulsion demonstrated the potential to significantly reduce intraocular pressure (IOP) – exceeding the capabilities of leading commercialized drugs in the current glaucoma market.
Additionally, it has been demonstrated:
- Skye’s SBI-100 ophthalmic emulsion formulation enables it to better enter various compartments of the eye vs natural THC
- Its formulation lowers IOP better than leading current prescribed drugs in animal models
- SBI-100 ophthalmic emulsion or its metabolite (THC) is not detectable in the plasma or brain tissue after topical administration to the eye
- THC in an ex vivo model demonstrated lowering of IOP and the reduction of biomarkers related to fibrosis, inflammation, and vasodilation, supporting a multimodal mechanism of action.
CBDVHS is a proprietary analog of cannabidiol (CBD) that has demonstrated biological activity that is both pharmacologically and therapeutically distinct from CBD in various preclinical models. Preliminary data suggest potential analgesic, anti-inflammatory, anti-fibrotic, anti-infective and anti-seizure activity of CBDVHS opening the door to multiple therapeutic applications. We are actively conducting additional preclinical studies to help determine and prioritize a well we defined development plan for CBDVHS.