A request for a potential cannabis-based treatment for multiple sclerosis to be given Fast Track designation, speeding its development as it readies to enter clinical testing, is now before the U.S. Food and Drug Administration (FDA), MMJ International Holdings announced.
MMJ-001, as this lead candidate is known, aims to treat the spasticity (muscle stiffness) associated with progressive multiple sclerosis. The company is also targeting Huntington’s-associated chorea, a neurological disorder characterized by jerky involuntary movements that particularly affect the shoulders, hips, and face.
Specifically, MMJ-001 is a liquid therapeutic formulation made from highly purified components of cannabis, cannabidiol (CBD) and tetrahydrocannabinol (THC), the company states on its website. CBD and THC are the most abundant cannabinoids in the cannabis plant; CBD is non-psychoactive component of the cannabis oil and believed to have neuro-protective properties, while THC is the principal psychoactive constituent of cannabis.
MMJ International is exploring the potential of a range of cannabinoid and other botanical molecules targeting neurological diseases, the company said in a news release.
It is also planning to bring MMJ-001 into a first “dose-ranging” study — a clinical trial testing different treatment doses to establish which dose works best and is safest and most tolerable, MMJ said in a separate release. In this study, still in the planning stages, researchers will compare therapeutic formulations of THC and CBD to placebo.
The request to place MMJ-001 on a fast track is related to its development as a therapy for primary progressive multiple sclerosis (PPMS). The FDA’s fast track expedites the review and approval of experimental treatments for serious or life-threatening diseases with the potential to fill patients’ unmet medical needs.
“The positive data from this dosing study is important in that it will provide us with the necessary evidence on patient tolerance to different doses of THC and CBD for the treatment for PPMS,” Duane Boise, the company’s CEO, said in the release. “This information will prove valuable to assist clinicians with prescribing decisions to address individual patient needs should this medicine be FDA approved for use.”
MMJ has also requested FDA approval to test its cannabis-based candidate in Huntington’s patients, announcing in August the filing of an Investigational New Drug (IND) application to begin clinical testing. MMJ-002, as its cannabis-based candidate for Huntington’s is known, was recently designed an orphan drug by the FDA and a Phase 2 clinical trial in Huntington’s patients is “scheduled,” the company said in a Feb. 13 release.
MMJ recently became the first company to obtain a Canadian license to produce medical cannabis products aiming to treat multiple sclerosis and Huntington’s disease.
If approved by the FDA, MMJ’s lead therapeutic will be one of the world’s first natural plant-derived cannabinoid pharmaceuticals for the treatment of spasticity and pain caused by multiple sclerosis and other neurological diseases.