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Skye Bioscience has a pipeline of synthetic cannabinoid drugs that can disrupt the way we treat dise


Skye Bioscience inc (OTCQB:SKYE), formerly known as Emerald Biosciences, is developing proprietary synthetic cannabinoid-derived molecules to treat glaucoma, a degenerative disease marked by irreversible vision loss and other challenging diseases with significant unmet needs.

The nimble San Diego, California-based biopharmaceutical company recently appointed a new CEO and changed its name from Emerald Bioscience to telegraph its rebirth and lofty ambitions.

A rebrand with promise

“As our new name Skye implies, the sky’s the limit when it comes to the boundless potential of cannabinoid-derived treatments for human disease. As an early stage company we have significant potential to be very disruptive across different therapeutic applications. The new name represents a new chapter for the company,” Skye CEO Punit Dhillon told Proactive.

“It’s been completely re-built from the ground up in the last 180 days with a whole new team. I have worked with some of the team members in varying different capacities over the last two decades.”

Dhillon has serious street cred as he cofounded and led cancer immunotherapy company OncoSec Medical through early development and a partnership with Merck & Company Inc (NYSE:MRK) to launch Phase 2/3 multicenter trials and raised over $200 million. The biotech veteran has also been the VP of Finance and Operations at Inovio Pharmaceuticals, where he helped raise more than $160 million.

With Dhillon in the saddle, Skye has gone through a rebrand that has promise. The company is now laser-focused on the development of a groundbreaking treatment for glaucoma which has a market opportunity of nearly $7 billion.

“Over the past few months, we have reinvigorated our business with a new team and strong commitment to advance the clinical development plan for our promising drug candidate to treat glaucoma,” said Dhillon.

How lead candidate THCVHS works

In a nutshell, a healthy eye has a fluid called aqueous humor, which usually drains out of the eye through a mesh-like system of canals. For an individual with glaucoma, these canals can get clogged, resulting in fluid build-up that leads to increased pressure in the eye — intraocular pressure (IOP) — which can damage the optic nerve. Here is the crux: If you lose vision, it can’t be brought back. But lowering eye pressure can help a person with glaucoma slow the process of vision loss and keep what sight they have.

Cannabinoids, specifically tetrahydrocannabinol (THC), the main psychoactive compound associated with marijuana, has been shown to decrease IOP, making it an ideal candidate for new glaucoma treatments. According to Skye, the eye is rich with cannabinoid receptors, specifically in tissues involved in managing fluid production and drainage. Skye solves tricky THC delivery issues through a pharmaceutical application of THC delivered directly into the eye.

Skye’s bioengineered synthetic prodrug of THC is called THCVHS. The company says VHS refers to the molecule valine-hemi-succinate, which is attached to the THC molecule to aid its delivery directly into the eye by enhancing solubility. This overcomes the previous challenge of delivering a therapeutic amount of THC into the eye without the resulting side effects caused by systemic delivery. Once inside the eye, THCVHS is converted back into THC by enzymes that clear the VHS arm of the molecule. THC can then perform its potential therapeutic function, which prior human studies have shown can lower IOP.

“Since September, our company has made significant progress on its development plan for its lead molecule, THCVHS, with important steps taken to finalize the formulation and manufacture of this drug,” said Dhillon.

“With the manufactured drug expected in the near term, we plan to conduct important preclinical studies to further validate intraocular-pressure-lowering activity as well as the potential neuroprotective benefits of our drug.”

Key milestones

Skye is gearing up to report key preclinical data around the third quarter of 2021 and share the first-in-human (FIH) data readout in the first half of 2022.

“With other IND-enabling preclinical work in motion, we are also well on our way toward our first clinical trial. These milestones represent a compelling set of outcomes that we believe can be impactful for the company,” added Dhillon.

Skye is also hoping to capitalize on the neuroprotective properties of cannabinoids to address another form of glaucoma called normal-tension glaucoma (NTG), which is characterized by neurodegeneration of the optic nerve, without eye pressure exceeding the normal range. NTG is widespread in China and India and roughly one-third of glaucoma patients globally fit into this category of the eye disease.

According to Dhillon, one of Skye’s planned preclinical studies will compare the intraocular-pressure-lowering capability of THCVHS against, and in combination with, two other market-leading glaucoma drugs.

“Another study will provide an initial assessment of THCVHS’ ability to provide neuroprotection, a capability that today is unavailable with current therapies. A neuroprotective drug could potentially help millions of patients, currently without any available treatment, from going blind – a significant and unfortunate outcome of glaucoma,” added Dhillon.

The company said that the FIH Phase 1 study of its lead candidate THCVHS to treat glaucoma will assess the safety and tolerability of single and multiple ascending doses. The study design will also provide an initial assessment of intraocular pressure in healthy patients with normal IOP as well as in a subset of patients with glaucoma and/or elevated IOP.

“We believe our unique, fully patented drug can avoid the adverse systemic effects of THC while providing superior IOP-lowering activity to help protect and preserve vision. As we move forward in 2021, we look forward to advancing our clinical objectives expeditiously and leveraging the compelling opportunities ahead of us,” said Dhillon.

In a rabbit model, THCVHS achieved superior decline in IOP versus eye pressure drug Latanoprost and ocular hypertension and glaucoma eye drop Timolol. According to the company, their candidate showed “superior duration of pharmacologic activity” and potential for once-only dosing.

Strong partnerships

The US cannabinoid-based pharmaceutical market is pegged to grow to $50 billion annually by 2029, according to Ackrell Capital.

Significantly, Skye has an exclusive relationship with the University of Mississippi (UM) through which it has acquired “all fields” licenses for THCVHS as well as an analog of cannabinol (CBD) called CBDVHS. The University of Mississippi has been the only federally licensed and funded entity in the US for the past 50 years to cultivate and research cannabis. Skye Bioscience is tapping this unique repository of academic research and intellectual property, and is taking the rigorous steps required to develop treatments derived from synthetic cannabinoids.

“We have a robust pipeline based on the proprietary molecules that we are working on, a valuable partnership with a leading university, and we are committed to developing these therapies further to help patients,” said Dhillon.

Contact the author Uttara Choudhury at [email protected]

Follow her on Twitter: @UttaraProactive

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