Cannabinoid that might help in Parkinson’s entering Phase 2 trial
Study in children with autism, but treating other diseases also key goal
Gcanrx soon will open a Phase 2 clinical trial of a neuroprotective cannabinoid treatment that the company expects could benefit people with a range of neurological conditions, including Parkinson’s disease.
The safety and efficacy trial, approved to take place in Israel, is expected to begin enrolling children with autism spectrum disorders in the “coming weeks,” GcanRx announced in a company press release.
“Positive results in this study carry promise for a novel treatment for [autism spectrum disorder] as well as for other neuropsychiatric disorders such as schizophrenia, Alzheimer’s disease, and Parkinson’s disease, which share similar pathophysiological processes, and can have an enormous impact on the lives of countless families as well as on public health,” said Aitan Zacharin, the company’s CEO.
Cannabis treatments of growing interest for diseases like Parkinson’s
Cannabinoids are a group of chemical compounds that are naturally found in the cannabis plant and known to have neuroprotective properties. They act on the endocannabinoid system, a complex network of signals and receptors involved in movement control, memory, hormone production, and immune functions.
Interest is growing in the use of cannabis to treat diseases like Parkinson’s.
The 12-week trial will evaluate the safety, tolerability, and efficacy of the cannabinoid treatment against a placebo, both given daily as an oil-based liquid, to children with autism spectrum disorders. Its main efficacy goal is to assess changes in behavior with treatment, measured using the Aberrant Behavior Checklist-Irritability Subscale (ABC-I) score, at week 12.
Safety will be evaluated through serious adverse events reported in children on treatment and on placebo, and the frequency of these events.
“This Phase II Clinical Trial will enable us to rigorously evaluate the safety and efficacy of our therapeutic, and we believe will further solidify its potential as a game-changing treatment,” Zacharin said.
A method of drug delivery involving a fully dissolvable bioadhesive patch system that enables oral delivery of multiple cannabinoids at different doses is detailed on the company’s website.
Gcanrx holds exclusive worldwide rights to the patch, developed by PharMedica and called the Eluting Transmuscosal Patch (ETP) Platform. However, this system will not be used in the Phase 2 trial due to its “regulatory timeline.”
Rather, “we plan to explore using our ETP technology in future studies once we have established [the] efficacy and safety of our therapeutic,” Zacharin said in an email response to Parkinson’s News Today.
The company also reports that treatments using this technology can be loaded onto the same multilayer patch, and delivered with controlled absorption rates, quick onset, and more accurate dosing.
The patch system, Gcanrx states on its website, can be used to administer “similar or different drugs, depending of the purpose of the medical treatment,” and allows for “a needle free, intra-oral systemic drug delivery.”