Emerald Health Begins Enrollment for Systemic Sclerosis Treatment Study

Emerald Health Pharmaceuticals (EHP) has begun enrollment and has dosed its first patients with diffuse cutaneous systemic sclerosis (dcSSc) in its Phase 2a clinical study of its lead product candidate, EHP-101, an oral formulation of a patented chemical entity derived from cannabidiol (CBD).

“The absence of approved treatment options for systemic sclerosis represents an urgent medical need and we are pleased to offer a clinical trial option for a new and promising treatment to patients with systemic sclerosis, even during these difficult and unprecedented times when recruitment and screening of patients for study eligibility was limited due to local regulations around the current pandemic,” said Dr. Joachim Schupp, EHP’s Chief Medical Officer. “The initiation of our Phase 2 study of EHP-101 represents an important milestone in the clinical advancement of our lead product candidate as a potential novel therapy for patients suffering from this debilitating disease.”

The Phase 2a study is a double-blind, randomized, intracohort placebo-controlled, multicenter study to evaluate the safety, tolerability, pharmacokinetics and preliminary efficacy of EHP-101 in up to 36 patients with dcSSc in approximately 30 study centers across Australia, New Zealand and the United States (US). EHP has initiated 6 clinical trial sites and enrolled 2 patients to date.

EHP-101 has been granted Orphan Drug Designation in the US and European Union (EU), and received Investigational New Drug application (IND) clearance and Fast Track Designation by the US FDA for SSc.

EHP remains on track to receive preliminary results from its Phase 2a study in SSc in early 2021, with anticipated study completion in mid-2021.

Preparations for the initiation of a Phase 2 study in multiple sclerosis are planned later this year.

Systemic sclerosis (SSc), a severe form of scleroderma, is a rare and chronic autoimmune disease, causing fibrosis of the skin and internal organs, including small blood vessel damage in the skin and multiple other organs in the body such as lung, heart, kidneys, musculoskeletal system and the gastrointestinal tract. The tissues of involved organs become hard and fibrous, causing them to function less efficiently. While the symptoms of SSc vary for each person, it can be life-threatening depending on which parts of the body are affected and the extent of the disease. SSc is subclassified into diffuse cutaneous SSc (dcSSc) or limited cutaneous SSc (lcSSc) based on the extent of skin involvement. Patients with the diffuse form have more areas involved, and measurements of the effects of treatment have been validated by international clinical trial experts for this subset of SSc patients.

The disease is more common in adults, with approximately 80,000-100,000 people affected in the US. Currently, there are no approved treatments specific to SSc. Current therapies for this disease include mainly drugs that suppress the immune system, are limited in efficacy and may present toxicities. New treatments will be critical to help reduce the symptoms of SSc and prevent further damage to the body.

EHP-101 is an oral formulation of VCE-004.8, a synthetic aminoquinone derivative of CBD with dual peroxisome proliferator-activated receptor gamma (PPARγ) and cannabinoid receptor type 2 (CB2) agonist activity. Both receptors are therapeutic targets for SSc. EHP-101 also modulates the hypoxia inducible factor (HIF) pathway, expanding the rationale for its development as a novel SSc drug. EHP has received Orphan Drug Designation for EHP-101 in SSc in both the US and EU and Fast Track Designation for systemic sclerosis in the US. The active pharmaceutical ingredient in EHP-101 has been deemed not to be a controlled substance by the US Drug Enforcement Administration (DEA).