XPhyto Therapeutics eyes pivotal 2022 clinical trial for epilepsy with CBD strips

The Vancouver company is developing three dissolvable cannabinoid products.

Cannabidiol or CBD is reputed for its potential medical applications. Caitlyn Riley/Getty Images


XPhyto Therapeutics Corp. expects to conduct clinical trials next year for epilepsy treatment using its oral CBD strips.

The study represents a crucial step in the Vancouver-headquartered company’s development of dissolvable cannabinoid products.

In addition, the tests in 2022 present the potential of relief for people suffering from severe forms of epilepsy, a brain disorder that causes seizures.

“If successful, this could make a significant difference to Epilepsy patients and we are excited to commence the trial next year,” Thomas Beckert, a managing director with XPhyto, stated in a media release Wednesday (December 15).

CBD or cannabidiol is one of many cannabinoids found in cannabis.

Unlike its psychoactive cousin THC or tetrahydrocannabinol, CBD does not cause a high or a mind-altering experience.

Cannabidiol has received a lot of attention because of its many potential medical applications.

XPhyto is developing three oral dissolvable cannabinoid products: CBD, THC, and a combination of CBD and THC.

Beckert said in the media release that the clinical trial for its CBD oral strips aims to demonstrate “efficient and precise dosing”.

Online, the Canadian Epilepsy Alliance Epilepsy explains that epilepsy is a neurological disorder of the central nervous system, which affects specifically the brain.

People dealing with the condition experience recurrent seizures.

The alliance noted that 70 percent of people with epilepsy can be treated with medication.

However, 30 percent suffer from drug-resistant epilepsy.

A 2019 study by Italian researchers noted that CBD has demonstrated “efficacy as anti-seizure, antipsychotic, neuroprotective, antidepressant and anxiolytic”.

CBD’s neuroprotective activity appears linked to its anti-inflammatory and antioxidant properties, wrote the authors of the paper titled “Use of Cannabidiol in the Treatment of Epilepsy: Efficacy and Security in Clinical Trials”.

“The results of scientific studies obtained so far the use of CBD in clinical applications could represent hope for patients who are resistant to all conventional anti-epileptic drugs,” the researchers noted.

In its December 15 release, XPhyto stated that it anticipates holding its “pivotal clinical study” in the second half of 2022.

To prepare, the company will start a “human CBD bioavailability study” in Europe in January next year.

Bioavailability simply means the absorption of a drug in the human body.

Moreover, results of bioavalability studies are subsequently used in bioequivalence testing, which is the comparison of two similar pharmaceutical products.

Both processes are involved in the development of new drugs.

XPhyto recalled that the US Food and Drug Administration and European Medicines Agency have approved CBD-based medical products from other companies for severe childhood epilepsy.

These conditions include Dravet and Lennox-Gastaut syndromes.

The Vancouver company related that approved formulations come in an oil solution with a standard dosage of 750 milligrams per day.

However, XPhyto noted, these available medications have a “low bioavailability” or rate of absorption of only about five percent.

Thus, current formulations could be considered “highly inefficient”.

In comparison, XPhyto claimed that its proprietary oral strips “deliver precise and efficient CBD dosages for the treatment of certain forms of childhood Epilepsy”.

The company trades in the Canadian Securities Exchange under the ticker symbol XPHY.

Follow Carlito Pablo on Twitter at @carlitopablo

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