Emerald Health Pharmaceuticals Receives IND Clearance to Begin Phase 2 Clinical Trial of EHP-101 for Relapsing Forms of Multiple Sclerosis

Emerald Health Pharmaceuticals Inc. has received clearance of its Investigational New Drug (IND) application by the U.S. Food and Drug Administration (FDA) to begin enrolling patients in its Phase 2a clinical trial of EHP-101 for certain relapsing forms of multiple sclerosis (RMS), specifically relapsing-remitting MS (RRMS) and active  secondary progressive MS (SPMS).

“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,” said Dr. Jim DeMesa, Chief Executive Officer. “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.  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.”

The international Phase 2a, open-label, multicenter dose-finding study in patients with RMS will evaluate the safety, tolerability, and preliminary efficacy of the Company’s lead product candidate, EHP-101. The study is designed to enroll 50 patients who suffer from RMS in approximately 30 study centers in the US, the EU, and Australia. Patients will receive escalating doses administered once or twice daily and will be evaluated over a treatment duration of 24 weeks.

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

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, and difficulty chewing, swallowing, and speaking. Currently, approved MS drugs are all primarily intended to relieve symptoms and reduce the rate of relapses – none are curative. Four disease courses have been identified in MS: clinical isolated syndrome (CIS), relapsing-remitting MS (RRMS), primary progressive MS (PPMS) and secondary progressive MS (SPMS).

The relapsing forms of multiple sclerosis include RRMS, SPMS and CIS. Relapsing remitting multiple sclerosis (RRMS) is defined by periodic neurologic symptoms caused by inflammatory attacks on myelin (the layers of insulating membranes surrounding nerve fibers in the central nervous system) as well as on nerve fibers themselves. During these inflammatory attacks, activated immune cells cause small, localized areas of damage (called demyelination) which produce the symptoms of MS. Approximately 85% of people with MS are initially diagnosed with RRMS.

Secondary progressive MS (SPMS) follows an initial relapsing-remitting course. Most people who are diagnosed with RRMS will eventually transition to a secondary progressive course in which there is a progressive worsening of neurologic function (accumulation of disability) over time. SPMS can be further characterized as either active (with relapses and/or evidence of new MRI activity during a specified period of time) or not active, as well as with progression (evidence of disability accrual over time, with or without relapses or new MRI activity) or without progression.

Clinical isolated syndrome (CIS) is a first episode of neurologic symptoms of MS. When CIS is accompanied by lesions on a brain MRI there is a high likelihood of a second episode and diagnosis of RRMS.

Emerald Health Pharmaceuticals is developing product candidates for the treatment of CNS, autoimmune, and other diseases. The Company has two families of patented new chemical entities designed to affect validated receptors and pathways pertinent to targeted diseases. Its first drug product candidate, EHP-101, has entered Phase 2a for the treatment of systemic sclerosis, a severe form of scleroderma, and multiple sclerosis. Its second product candidate, EHP-102, is in preclinical development and is focused on treating Parkinson’s disease and Huntington’s disease. EHP-101 has received Orphan Drug Designation in the US and EU and Fast Track designation in the US for systemic sclerosis and EHP-102 has received Orphan Drug Designation in the US and EU for Huntington’s disease. For more information, visit http://www.emeraldpharma.com.