Glauconix completes cannabinoid pilot study

Study confirms intraocular pressure-lowering effects, proving promising novel treatment for glaucoma

Mel J. Yeates
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ALBANY, N.Y.—Glauconix Biosciences Inc. revealed in March that the data generated for Nemus Biosciences Inc. validates the mechanism of action of NB1111, Nemus’ proprietary prodrug of tetrahydrocannabinol (THC-valine-hemisuccinate, or THCVHS), in lowering intraocular pressure (IOP), a defining symptom of hypertensive glaucoma. Glauconix is located at the SUNY Polytechnic Institute’s Albany, N.Y., campus, and is a partner in the institution’s Center for Advanced Technology in Nanomaterials and Nanoelectronics (CATN2).
 
Glauconix used its 3D human trabecular meshwork model (3D-HTM), which consists of human donor cells containing the ocular tissue responsible for helping to regulate intraocular pressure: the trabecular meshwork. The studies included a comparison of the activity of tetrahydrocannabinol (THC), the biologically active part of NB1111, in facilitating fluid drainage and lowering levels of biomarker molecules associated with inflammation and fibrosis, two processes associated with tissues that are damaged in a disease setting.
 
“The Glauconix Biosciences’ 3D-HTM technology was designed to help accelerate drug development by using bioengineered human donor 3D tissue models for target identification and validation, high-throughput screening and drug efficacy with physiological endpoints, such as fluid outflow,” said Dr. Karen Torrejon, founder and chief scientific officer of Glauconix. “Historically, our technology has exhibited significant predictive value in assessing a drug candidate’s utility and likelihood of clinical success. Nemus’ data helps to provide a rationale for cannabinoid activity in lowering IOP and indicates a potential for the advancement of NB1111 into clinical testing.”
 
Researchers have previously demonstrated that ocular tissues possess a large number of cannabinoid receptors, especially in areas that help regulate IOP. Given that THC binds both types of cannabinoid receptors, these data point to a unique mechanism of action whereby the ability of THC to bind to cannabinoid receptors results in a beneficial decline in IOP, due to enhanced fluid drainage. When IOP is left unchecked there is often damage to the optic nerve, leading to irreversible vision loss.
 
Additionally, biomarkers associated with inflammation and fibrosis in tissues affected by glaucoma were significantly decreased, pointing to anti-inflammatory and antifibrotic activities that are often associated with the cannabinoid class of molecules in other disease states.
 
“These studies were significant across a spectrum of findings, and we plan on submitting the data to an upcoming major ophthalmology meeting. Micro-quantities of cannabinoid delivered directly into the eye could have the dual benefit of a therapeutic effect while mitigating risk of systemic adverse events through direct tissue targeting, an advantage associated with using bioengineered molecules,” added Dr. Brian Murphy, CEO and chief medical officer of Nemus.
 
In other recent cannabis news, a report from Arcview Market Research (Arcview Group) and BDS Analytics has pointed out the many ways in which the cannabis industry may potentially disrupt the pharmaceutical industry. Entitled “Pharmacies vs. Dispensaries: The Future of Cannabinoids as Medicine,” the report explains that the pharmaceutical industry stands to be changed by the popularization of cannabis in two ways: the emergence of cannabis-derived pharmaceutical drugs, and the possible competition between pharmacies and dispensaries as customers begin to trust cannabis to alleviate health issues.
 
“A slow pace of change is typical of the pharmaceutical industry, but medical cannabis could change that,” explained Troy Dayton, CEO of the Arcview Group. “It was the medical cannabis industry that initially provided CBD-based relief to children with epileptic seizures, and is currently helping thousands of patients who are suffering from a vast array of other conditions. Now the pharmaceutical industry is slowly emerging from 80 years of prohibition-induced neglect towards the potential of cannabis-plant medicines.”
 
The report indicates that cannabinoid pharmaceutical sales are unlikely to take off in the near term, as only five cannabinoid-based pharmaceuticals are in third-stage trials and have a chance of getting through the FDA approval process and onto the market before 2022. That said, sales of cannabis-based pharmaceuticals are projected to make up 10 percent of the $31.6-billion legal cannabis market by 2022. The report also notes that growth in revenue from cannabinoid pharmaceuticals will accelerate in the second half of the decade ahead, as more drugs are approved and fully commercialized.
 
Tom Adams, editor in chief of Arcview Market Research and managing director of BDS Analytics Industry Intelligence, said, “Epidiolex and the pipeline of pharmaceuticals behind it set up a whole new competitive dynamic. For the first time, cannabis dispensaries will face pharmaceutical competition with its FDA imprimatur and the potential advantage of insurance subsidization … at the same time, the pharmaceutical industry is not used to competing with stores selling effectively the same product it offers at a much lower price.”
 
The report also noted that 41 percent of BDS Analytics’ consumer surveys respondents report a reduction in the use of OTC medications when using medical cannabis, while 39 percent report a reduction in use of prescription medications. According to statistics tracked through the government’s Medicaid programs in states with legal medical marijuana programs, opioid drug use is reported to have decreased by up to 30 percent. In addition, approximately 770 clinical trials involving cannabis, which include the use of cannabinoids for treatment of dozens of disorders and diseases, were registered with the U.S. federal government as in process as of January 2019.

Mel J. Yeates

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