Envisioning a new future for the treatment of disease with significant unmet needs.
At Skye Bioscience we are focused on leveraging an important physiological system in the body that has only been recognized since the 1990s and is relatively overlooked as a target for drug development. Based on powerful natural molecules, we aim to develop novel, patent-protected, and impactful drugs to treat glaucoma and other significant diseases.
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 systems in the body has been well-documented in many peer-reviewed scientific publications, representing a potentially attractive 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 a leader in exploring and advancing this burgeoning area of medicine.
We’re working to transform groundbreaking research into clinically and commercially differentiated medicines.
Through the application of rational drug design, our chemically-engineered cannabinoid-derived molecules have demonstrated in nonclinical models enhanced pharmacological attributes that may be capable of providing enhanced therapeutic benefits compared to natural cannabinoids and existing approved therapies.
Our rigorous scientific approach seeks to realize the pharmaceutical potential of cannabinoids and other molecules that affect the endocannabinoid system in an effort to transform the treatment of significant diseases.
SBI-100 Ophthalmic Emulsion
Our lead candidate, SBI-100 Ophthalmic Emulsion (“OE”), a novel prodrug of tetrahydrocannabinol (THC), is a proprietary topical formulation under development for the treatment of glaucoma and ocular hypertension (OHT).
Third party research in humans has shown that THC can reduce intraocular pressure (IOP), which is partly responsible for the crush-like injury to optic nerve cells that can result in blindness associated with glaucoma. Other nonclinical studies have shown the unique potential for THC to also provide neuroprotective benefit – which no other approved drug offers and may be especially important to patients experiencing glaucoma disease progression with normal IOP levels.
The prior research also highlighted the drawbacks of the available methods of THC administration assessed: smoking, oral ingestion, and topical formulations (using mineral oils) applied to the eye. These drawbacks included short duration of effect, toxicity, and psychotropic effects. While local topical administration of THC is alluring, the inherent lipophilic, nature of THC and delivery formulations used makes them incompatible with the aqueous nature of the eye, ie oil and water don’t mix. They have not worked!
Skye’s SBI-100 OE consists of chemically modified THC, resulting in a unique synthetic THC derivative molecule, combined with a proprietary nanoemulsion formulation, both elements designed to enable topical administration and significant penetration into different compartments of the eye. Our objective is to achieve a clinically-validated drug that provides IOP-lowering benefits while minimizing side effects. In the future we would also aspire to characterize neuroprotective benefits of SBI-100 OE that would be unique in the clinical realm.
SBI-100 Ophthalmic Emulsion and glaucoma
Glaucoma is a subset of eye diseases that can cause vision loss and blindness by damaging cells of the optic nerve in the back of the eye. With certain types of glaucoma, damage to the optic nerve is caused by increased IOP due to improper drainage and/or overproduction of fluid in the eye.
According to the Glaucoma Research Organization, glaucoma affects over 60 million people worldwide and is the leading cause of blindness in adults aged 60 and older.
Current therapies attempt to lower IOP by either decreasing fluid production or increasing drainage of fluid. However, nearly 40% of patients will not respond to first-line therapies, and 50% of patients will eventually require taking two or more classes of therapy to manage their IOP, creating a significant opportunity for new and more effective classes of therapy.
In nonclinical studies, Skye’s SBI-100 Ophthalmic Emulsion demonstrated a greater and longer-lasting reduction of IOP compared to leading commercialized drugs in the glaucoma market. These studies also demonstrated:
- SBI-100 Ophthalmic Emulsion is better at penetrating various compartments of the eye than natural THC
- THC in an ex vivo model demonstrated a reduction of biomarkers related to fibrosis and inflammation in conjunction with lowering of IOP, supporting a multimodal mechanism of action.
SBI-200 is a proprietary derivative 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 SBI-200, opening the door to multiple therapeutic applications. We are conducting additional nonclinical work to help define a potential development plan for SBI-200.
Cannabinoid Pharmaceutical Innovation Program
Skye’s Cannabinoid Pharmaceutical Innovation Program (CPIP) is a research initiative focused on developing new molecules that affect important signaling pathways in the endocannabinoid system in the eye. We believe targeting these receptors has the potential to positively impact multiple diseases in the eye. CPIP reflects the company’s commitment to cannabinoid-based science and cutting-edge research. Through CPIP, Skye expects to screen up to 100 molecules by mid-2023 to build a library of novel cannabinoid derivatives and small molecules. The molecules will be screened using a proprietary screening platform developed by Skye to analyze key molecular targets related to a range of disease pathways.
CPIP leverages R&D initiatives with key opinion leaders who are associated with specialized research centers such as the Spanish Research Council, University of Cordoba, and University of Eastern Piedmont in Italy. Skye sponsors the research with its collaborators and all intellectual property developed under its established contract research agreements will be solely owned by Skye.
The University of Mississippi granted Skye exclusive “all fields” license agreements for SBI-100 and SBI-200, giving Skye the right to develop theses molecules to treat any disease through any form of delivery. The patents encompassed by these agreements cover composition of matter and methods of use.
Skye intends to continue to seek patent protection for certain of its product candidates, drug delivery systems, molecular modifications, as well as other proprietary technologies and their uses in the U.S. and globally.