Trial of Cannabidiol-derived EHP-101 for Relapsing MS Enrolling Soon

by Yedida Y Bogachkov PhD | January 14, 2022

Emerald Health Pharmaceuticals will soon begin enrollment in a Phase 2a clinical trial investigating its cannabidiol-derived therapy EHP-101 in relapsing forms of multiple sclerosis (MS).

The trial (NCT04909502) aims to recruit 50 patients, ages 18-55, with relapsing-remitting MS (RRMS) and active secondary progressive MS (SPMS). It follows the clearance of the company’s investigational new drug application by the U.S. Food and Drug Administration (FDA).

Enrollment is expected to take place at about 30 locations in the European Union, the U.S., and Australia. More information on contacts and locations will be available here.

“The absence of therapeutic options that go beyond treating symptoms, inflammation and reducing the incidence of relapses represents a significant unmet need for multiple sclerosis patients,” Jim DeMesa, MD, CEO of Emerald Health, said in a press release.

EHP-101 is an oral therapy whose active ingredient is derived from cannabidiol or CBD — the most well-known non-psychoactive component of the cannabis or marijuana plant. It has various biological activities that may be beneficial for patients with MS, without inducing the “high” associated with tetrahydrocannabinol (THC), the other better-known component of cannabis.

Preclinical studies in MS mouse models showed that EHP-101 can reduce inflammation in the brain and promote remyelination — the regeneration of the myelin sheath that covers nerve fibers and is progressively damaged in MS.

The treatment also was found to be safe and well-tolerated in a Phase 1 clinical trial (NCT03745001), completed in 2019, involving more than 100 healthy volunteers. Only mild to moderate adverse events were reported in that study.

“Our preclinical studies of EHP-101 demonstrated a promising effect on disease progression by preventing demyelination of the neurons, the major issue associated with MS, but also by stimulating their remyelination or regeneration of new myelin, in several multiple sclerosis animal models,” DeMesa said.

The upcoming Phase 2a trial will further evaluate the safety and tolerability of EHP-101 in people with relapsing forms of MS, in which active inflammation mainly contributes to disease progression.