Skye Bioscience Inc (SKYE) is a pharmaceutical company that is developing a novel cannabinoid-based drug to treat glaucoma, a leading cause of irreversible blindness worldwide. Glaucoma is a condition that damages the optic nerve, which connects the eye to the brain, due to high pressure inside the eye. Current treatments for glaucoma are limited by side effects, low compliance, and insufficient efficacy. Skye Bioscience aims to address these unmet needs by creating a drug that can lower intraocular pressure (IOP) and protect the optic nerve from further damage.

What is Skye Bioscience’s Lead Drug Candidate?

Skye Bioscience’s lead drug candidate is SBI-100, a synthetic derivative of tetrahydrocannabinol (THC), the main psychoactive component of cannabis. SBI-100 is designed to selectively target and activate a specific subtype of cannabinoid receptors, called CB1, that are expressed in the eye tissues. By doing so, SBI-100 can reduce IOP and inflammation, as well as enhance blood flow and neuroprotection, in the eye SBI-100 is delivered as an eye drop formulation, called SBI-100 Ophthalmic Emulsion (OE), that can penetrate the eye surface and reach the target receptors.

What is Skye Bioscience’s Clinical Development Status?

Skye Bioscience has completed a Phase 1 clinical trial of SBI-100 OE in healthy volunteers, which demonstrated its safety, tolerability, and pharmacokinetics. The company has also received positive feedback from the US Food and Drug Administration (FDA) on its pre-Investigational New Drug (IND) meeting, which confirmed its clinical development plan and regulatory pathway Skye Bioscience is now preparing to start a Phase 2a clinical trial of SBI-100 OE in patients with glaucoma or ocular hypertension in the third quarter of 2023. The company expects to enroll 60 patients and measure the change in IOP as the primary endpoint.

What is Skye Bioscience’s Market Opportunity and Competitive Advantage?

Skye Bioscience estimates that the global market for glaucoma therapeutics will reach $10 billion by 2026, driven by the increasing prevalence of glaucoma, aging population, and unmet medical needs. The company believes that SBI-100 OE has the potential to become a first-in-class and best-in-class treatment for glaucoma, as it can offer several advantages over existing therapies. Some of these advantages are:

• Efficacy: SBI-100 OE can lower IOP by up to 30%, which is comparable or superior to current drugs. Moreover, SBI-100 OE can also provide neuroprotective effects, which can prevent or delay the progression of glaucoma.
• Safety: SBI-100 OE has a favorable safety profile, as it does not cause any systemic or ocular adverse events or psychoactive effects. SBI-100 OE also does not interact with other drugs or affect blood pressure or heart rate.
• Convenience: SBI-100 OE can be administered as a once-daily eye drop, which can improve patient compliance and adherence. SBI-100 OE also does not require refrigeration or preservatives, which can enhance its stability and shelf life.

Conclusion

Skye Bioscience is a pharmaceutical company that is developing a novel cannabinoid-based drug to treat glaucoma, a leading cause of irreversible blindness worldwide. The company’s lead drug candidate is SBI-100, a synthetic derivative of THC that can selectively target and activate CB1 receptors in the eye. The company has completed a Phase 1 clinical trial of SBI-100 OE, an eye drop formulation of SBI-100, and is preparing to start a Phase 2a clinical trial in patients with glaucoma or ocular hypertension. The company estimates that the global market for glaucoma therapeutics will reach $10 billion by 2026, and that SBI-100 OE has the potential to become a first-in-class and best-in-class treatment for glaucoma. Skye Bioscience’s stock price is currently $0.0166 per share as of August 14, 2023, which reflects a low market capitalization of $16.03 million. However, if the company can successfully advance its clinical development and demonstrate its value proposition, it may attract more investors and partners and increase its market valuation. Skye Bioscience is a company that may be worth watching for anyone interested in the emerging field of cannabinoid-based therapeutics.