by Yedida Y Bogachkov PhD | January 14, 2022
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.
In the trial, participants will receive ascending doses of EHP-101, given once or twice a day, for 24 weeks (about six months). After an initial screening period of up to four weeks, patients will start with a 25 mg dose of EHP-101, once or twice a day, which will be increased to 50 mg (also once or twice daily) after another four weeks.
The main goal of this trial is to determine the safety and efficacy of EHP-101 in MS patients. Secondary efficacy measures include changes in brain lesion activity on MRI scans, as well as changes in disability status and neurological impairment, time to first relapse, and relapse rates.
Other measures include changes in neurofilament light chain in the blood — a well-known biomarker of nerve cell damage — and structural assessments of the brain to identify remyelination.
“We look forward to assessing some of the
early indicators of activity of EHP-101 in this Phase 2a study of patients suffering from relapsing forms of MS, the most common disease course,” DeMesa said.