Small Biotech Unlocking Value Of Cannabinoids

| March 8, 2022

Note: The following is an advertorial for Skye Bioscience…

Glaucoma is the world’s leading cause of irreversible blindness and the leading cause of blindness in people over 60.

Glaucoma affects nearly 80 million patients worldwide and is projected to reach 110 million by the year 2026. The current course of treatment for glaucoma represents a $7 billion dollar market that is primarily made up of generic prostaglandin analogs or beta blocker treatments.

Skye Bioscience, Inc. (OTCQB: SKYE), a biopharmaceutical company, is developing its novel THC prodrug, SBI-100, to slow cell death of the optic nerve caused by glaucoma’s increased intraocular pressure and, in the process, change the way the disease can be treated in the future.

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Skye’s novel THCVHS molecule in SBI-100 is designed to have physicochemical properties that increase the solubility and polarity of THC, allowing for an effective topical delivery directly into the eye.

Once in the eye, THCVHS is metabolized back into THC where it can produce its therapeutic effect through receptors of the endocannabinoid system (ECS), namely CB1 receptors.

By targeting endocannabinoid receptors, Skye Bioscience has been able to produce a proprietary synthetic molecule that helps ocular tissue more readily accept the treatment.

And since this synthetic molecule is not found anywhere in nature, Skye Bioscience is able to protect its novel molecule with patents.

THCVHS has been formulated into a proprietary topical ophthalmic emulsion, referred to as SBI-100, which enables and enhances its therapeutic effects.

In preclinical studies, SBI-100 has demonstrated its ability to significantly decrease intraocular pressure (IOP) with greater intensity and over a longer duration than the top two treatments currently available today, which represent nearly

80% of a $7 billion market

Over the next 12 months, Skye Bioscience will transition from a preclinical to a clinical company by initiating a Phase 1 safety and tolerability study in Q2-22, as well as advancing activities to initiate a Phase 2 proof of concept study on dose-ranging and efficacy before the end of 2022.

Entering the clinic could be a pivotal time for Skye Bioscience as the interest in cannabinoid treatments continues to grow.

2021 saw the acquisition of GW Pharmaceuticals by Jazz Pharmaceuticals for $7.2 billion. This was the largest acquisition in the cannabis and cannabinoids sector to date.

GW Pharmaceuticals, which developed a novel formulation containing plant-derived CBD to treat childhood epilepsy, was able to patent its proprietary formulation but not the active pharmaceutical ingredient (API) in the formulation (CBD), because it is a naturally occurring molecule and therefore not patentable.

Skye Bioscience, on the other hand, can patent both its formulation and API because its novel molecule is not found in nature and is proprietary to Skye.

Skye’s composition of matter patent means there could potentially be less competition and more value creation in the future and makes Skye Bioscience a company worth watching closely as it potentially unlocks significant value over the coming months.

Recently, the company announced the launch of its Cannabinoid Pharmaceutical Innovation Program (CPIP), an initiative to advance novel cannabinoid research and development and expand the pipeline of molecules and intellectual property. The program consists of a coalition of partners with existing expertise working together to accelerate the discovery and development of new drugs and unlock the potential of pharmaceutical cannabinoids.

Skye Bioscience at a Glance

  • Licensed a novel compound for the treatment of glaucoma that takes advantage of proven therapeutic benefit while reducing unwanted side effects
  • In preclinical studies the lead compound demonstrated superiority to currently commercially available drugs that make up 80% of a $7 billion addressable market
  • Significant near-term potential to increase value over the next 12 months with plans to complete a Phase 1 safety trial and initiate Phase 2 efficacy trial.

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