The following post was written and/or published as a collaboration between Benzinga’s in-house sponsored content team and a financial partner of Benzinga.
The beginning of 2021 marked the start of a busy time for cannabinoid biopharmaceutical company Skye Bioscience, Inc. SKYE, not the least of which is the company's transition from its previous name, Emerald Biosciences, to its new and ambitious imprimatur.
“I'm excited about this current chapter of the company,” explained Skye Bioscience CEO Punit Dhillon in a recent interview with Benzinga. “The new name reflects a reset for the company that better represents our goal to be a leader in advancing cannabinoid science.”
The new year also introduced to the calendar a series of incoming results from pre-clinical and clinical-enabling studies on Skye Bioscience’s leading glaucoma drug, which is derived from the company’s proprietary modified THC compound. Should the results prove positive, they would pave the way for an Investigational New Drug (IND) application into what is a potentially $7 billion drug category.
According to Dhillon, the studies, which are set to conclude over the next 12 months, look to deliver exciting insights into the safety and efficacy of the locally-administered drug in both reducing and regulating intraocular pressure (IOP) as well as a potentially first-in-class mechanism for protecting optic nerve cells.
A New Approach
With its first-in-class THC-derived compound, the team at Skye is hoping to validate superior IOP-lowering relative to other commercially available drugs in humans. Glaucoma affects nearly 80 million people worldwide and is the leading cause of irreversible blindness.
“Ours is the first and only cannabinoid-derived prodrug designed for ocular use that lowers pressure through the interaction of THC with cannabinoid receptors found in the eye,” said Dhillon. “That's what makes it unique and potentially capable of protecting important optic nerve cells that can become damaged due to elevated intraocular pressure. The interaction may also provide other benefits, including the potential for neuroprotection, which is another body of research that's been pursued with regards to cannabinoids and ocular conditions.”
Glaucoma is a class of disease that causes progressive damage to optic nerve cells and is primarily the result of excess fluid buildup in the eye due to blockage or other disruption in its ability to drain that fluid. This excess fluid creates increased IOP that then inflicts a crush-like injury to optic nerve cells. There is another class of glaucoma that does not result from increased IOP and is instead due to neurodegeneration of the optic nerve cells. There are no treatment options available for this form of glaucoma, which affects about one-third of the global glaucoma population
Dhillon explained that the current IND-enabling trials they are conducting are aimed at the direct interaction of the THC compound with the cannabinoid receptors in the eye. This interaction has been demonstrated to reduce IOP by improving the organ’s drainage and widening the canal that is necessary for that flow to happen.
At the same time, Skye Bioscience is also conducting pre-clinical trials to investigate the THC compound’s neuroprotective attributes. If proven effective, it would represent an entirely new approach in treating the root cause of blindness from glaucoma, which is damage to the ocular nerves.
Filling In Gaps
The unique mechanism of action that Skye Bioscience is pursuing for its THC compound’s primary indication stands to disrupt the existing catalog of glaucoma treatments.
There are currently just a handful of primary drug classes indicated for glaucoma, with the largest market share belonging to prostaglandin analogs that help increase the drainage of intraocular fluid. However, Dhillon also explained how many patients respond poorly or can develop a tolerance to currently marketed drugs and are often required to take different drugs in combination which can lead to other undesired effects.
“The challenge of the existing classes of treatments, and the opportunity Skye Bioscience is pursuing with its THC compound, is that the majority of glaucoma patients don't respond well to any one drug treatment. They become tolerant of the drugs, more than 50% of patients will end up on two or more drugs to manage their glaucoma, and ultimately none of the current drugs provide any neuroprotection, a benefit that may be offered through a cannabinoid-based approach.”
A Clear Vision
Looking ahead, Dhillon expressed optimism regarding the compound’s ongoing IND-enabling studies, which he expects will provide preliminary insight regarding the safety and tolerability of the compound. He anticipates results from these studies sometime in Q1 and Q2.
“The next group of studies to expect from us are head-to-head comparisons between our molecule and two of the leading drugs out there, Rhopressa and Latanoprost,” said Dhillon. “We aim to demonstrate the superiority of our drug through additional reduction of IOP as well as a preclinical optic nerve injury study, which is designed to demonstrate the potential neuroprotection capabilities.”
While Skye Bioscience’s primary focus is currently its glaucoma drug, Dhillon hinted at other indications they are investigating for their THC compound.
“Our focus right now is on demonstrating the efficacy of the THCVHS molecule and progressing to human studies, but we’re looking at additional applications for a variety of different diseases,” said Dhillon. “We also have a CBD analog that we’re researching for a multitude of different benefits ranging from anti-pain, anti-inflammatory, to anti-infective.
“There are a vast number of opportunities that cannabinoid-based therapies can offer and we're excited to work with this initial set of data and apply these molecules toward new and more effective treatments.”
The preceding post was written and/or published as a collaboration between Benzinga’s in-house sponsored content team and a financial partner of Benzinga. Although the piece is not and should not be construed as editorial content, the sponsored content team works to ensure that any and all information contained within is true and accurate to the best of their knowledge and research. This content is for informational purposes only and not intended to be investing advice.
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