The study will take place in about 20 locations in the U.S. and Australia, and is expected to include approximately 50 patients with relapsing forms of MS — relapsing-remitting and relapsing secondary progressive MS. Enrollment is expected to begin later this year.
“The initiation of this MS Phase 2 study is another important milestone for our lead product candidate, EHP-101,” Joachim Schupp, MD, EHP’s chief medical officer, said in a press release.
“We have finalized the trial design with our MS Clinical Advisory Board members, who are globally-recognized key clinical opinion leaders in the treatment of MS,” he said. “We will soon be seeking regulatory approvals to begin the study and look forward to starting clinical site initiations and enrolling multiple sclerosis patients later this year.”
EHP-101 is an oral compound whose active ingredient is a derivative of cannabidiol (CBD). CBD is one of the better-known active chemicals found in the cannabis plant, the other being tetrahydrocannabinol (THC). CBD is associated with a number of health benefits but does not produce the “high” associated with THC.
In preclinical mouse studies, EHP-101 reduced inflammation and promoted remyelination – the regrowth of the myelin sheath that insulates nerve cells from signal loss and is damaged in MS. The treatment also demonstrated a good safety and tolerability profile in 104 healthy people participating in a Phase 1 clinical trial (NCT03745001), with only mild-to-moderate adverse side effects reported.
The upcoming MS Phase 2 trial trial will investigate the safety and tolerability, as well as the preliminary effectiveness and pharmacokinetics (how a chemical moves through the body) of EHP-101 in relapsing forms of MS.
Participants will receive escalating doses of EHP-101 once or twice daily over 24 weeks (about six months). The doses chosen in this trial come from two animal toxicity studies and the healthy volunteer trial.
In addition to safety and tolerability, the trial will assess changes in brain lesion activity, as measured by MRI, disease progression, and disability status.
Investigators also will analyze the proportion of relapse-free patients, patient-reported outcomes, and changes in several biomarkers, such as blood levels of neurofilament light chain (NfL), which has shown promise as an indicator of MS progression and is associated with various features of the disorder.
An ongoing Phase 2 trial (NCT04166552) also is investigating EHP-101 in adult people with diffuse cutaneous systemic sclerosis. Participants will receive one or two daily doses of the active treatment or a placebo for about six months.
“This MS clinical study is the second Phase 2 study we are conducting with EHP-101,” said Jim DeMesa, MD, EHP’s president and CEO.
“Our other Phase 2 study is in systemic sclerosis, a severe form of scleroderma, which is enrolling patients in the United States, Australia and New Zealand. These two Phase 2 studies provide us the opportunity for significant clinical milestones in 2022 and beyond,” he said.
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