Emerald Health Pharmaceuticals (EHP) has initiated activities for a Phase 2 international clinical study for the treatment of patients with multiple sclerosis (MS).

“The initiation of this MS Phase 2 study is another important milestone for our lead product candidate, EHP-101,” said Joachim Schupp, M.D., Dr. med., EHP’s Chief Medical Officer. “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. 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.”

The MS Phase 2 study is an open label study to evaluate the safety, tolerability, pharmacokinetics and preliminary efficacy of the company’s lead product candidate, EHP-101, an oral formulation of a patented new synthetic molecule, in patients with relapsing forms of multiple sclerosis (RMS). The study is planned to enroll approximately 50 patients who suffer from RMS (relapsing-remitting and relapsing secondary progressive MS) in approximately 20 study centers in the United States and Australia. Escalating doses administered once or twice daily are planned to be evaluated over a treatment duration of 24 weeks. The dose levels were established based on previous successful 6 and 9-month animal toxicity studies and a Phase 1 human study in 104 healthy subjects, all showing a good safety and tolerability profile.

Along with assessments of safety and tolerability, efficacy endpoints in the Phase 2 MS study will include the changes from baseline in brain lesion activity as measured by MRI; disease progression and disability status, as well as the proportion of relapse-free patients, patient-reported outcomes, and assessments of several biomarkers such as changes in the neurofilament light chain (NfL) levels in the blood, which is a promising diagnostic, prognostic and monitoring biomarker used in assessing neurological diseases.

In 2020, the company presented promising remyelination (restoration of the protective myelin sheath around the nerves) data in animal models of MS at the Americas Committee for Treatment in Multiple Sclerosis (ACTRIMS) conference.

“This MS clinical study is the second Phase 2 study we are conducting with EHP-101. 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,” Jim DeMesa, M.D., M.B.A., EHP’s President and CEO, said.

Multiple sclerosis is an inflammatory and demyelinating disorder of the central nervous system affecting an estimated 2.3 million people worldwide. Myelin is a sheath around nerves that aids in conducting nerve impulses. Demyelination is a breakdown of this sheath and in people with MS it is not reversible naturally or through existing therapies. As MS progresses, it affects muscles, nerves, and joints, causing significant pain, as well as spasms, stiffness, difficulty chewing, swallowing, and speaking. Currently, approved MS drugs are all primarily intended to relieve symptoms and reduce the rate of relapses, but none are curative.