Emerald Health Pharmaceuticals Initiates Phase 2 Clinical Study in Systemic Sclerosis

Tuesday, 31. March 2020 19:14

Novel product candidate, EHP-101, has received Orphan designation and demonstrated a unique multi-pronged mechanism of action related to the treatment of systemic sclerosis

SAN DIEGO, CA, March 31, 2020 (GLOBE NEWSWIRE) -- Emerald Health Pharmaceuticals Inc. (EHP), a clinical-stage biotechnology company developing medicines based on cannabinoid science, has initiated a Phase 2a international clinical study for the treatment of patients with systemic sclerosis (SSc), a severely debilitating and life-threatening form of scleroderma.

The Phase 2a study is a double-blind, placebo-controlled 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 molecule, in patients with diffuse cutaneous systemic sclerosis (dcSSc), which is characterized by fibrosis in the skin and internal organs.  The study will enroll 36 patients who suffer from dcSSc in approximately 30 study centers in the United States (US), Australia and New Zealand. A total of four doses (administered once or twice daily) have been selected for investigation based on the recently completed Phase 1 study in 104 healthy subjects.

Along with assessments of safety and tolerability, efficacy endpoints in the Phase 2a study will include the Composite Response Index in SSc (CRISS), validated patient-reported outcomes, quality-of-life assessments, as well as disease and drug-related biomarkers associated with the multiple organs affected by the disease and EHP-101’s mechanism of action. CRISS examines significant new or worsening organ involvement and changes in five variables — (1) skin thickness, measured as modified Rodnan Skin Score, (2) lung capacity, (3) patient assessment, (4) physician assessment of disease activity, and (5) the Scleroderma Health Assessment Questionnaire Disability Index (HAQ-DI) .

Further details about the study design can be found on ClinicalTrials.gov: NCT04166552.

“This is our first Phase 2 clinical study, which is another important milestone for our lead product candidate,” said Dr. Joachim Schupp, EHP’s Chief Medical Officer. “Regulatory approvals are in place and we have started site initiations. While the current COVID-19 pandemic presents some temporary challenges, we continue working remotely with the investigators and clinical site personnel and look forward to soon enrolling systemic sclerosis patients without risking their health or the health of study personnel.”

John Varga, MD, Director of the Northwestern Scleroderma Program in Chicago and a Clinical Advisory Board member of EHP added, “A safe and efficacious therapy for systemic sclerosis is clearly needed since there is currently no approved treatment. With its unique, targeted and multi-pronged mechanism of action, EHP-101 has the potential to be a significant advancement for patients with this life-threatening disease.”

EHP-101 was granted Fast Track Designation by the FDA as well as Orphan Drug Designation for SSc in both the US and European Union (EU).  EHP is also developing this drug candidate for multiple sclerosis (MS), and a Phase 2 study in MS is planned for later in the year. The Company recently presented its Phase 1 clinical results and preclinical remyelination data (restoration of the protective myelin sheath around nerves) at the Americas Committee for Treatment in Multiple Sclerosis (ACTRIMS) conference.

About Systemic Sclerosis and EHP-101

Systemic sclerosis (SSc), a severe form of scleroderma, is a rare and chronic autoimmune disease characterized by excessive production and accumulation of collagen, called fibrosis, in the skin and internal organs, such as lung, heart, kidneys, musculoskeletal system and the gastrointestinal tract, and by small blood vessel damage. 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; measurements of the treatment effects have been validated by international clinical trial experts for this subset of SSc patients.

The disease is more common in adults, with estimates of more than 200,000 people affected in the US, Europe, Australia and Japan. 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 is developing drug product candidates from its portfolio of patented cannabinoid derivatives, one derived from cannabidiol (CBD) for multiple sclerosis and systemic sclerosis (EHP-101). EHP-101 is an oral formulation of a synthetic aminoquinone derivative of CBD endowed with dual peroxisome proliferator-activated receptor gamma (PPARɣ) and cannabinoid receptor type 2 (CB2) agonist activity. Both receptors are therapeutic targets for SSc. EHP-101 also targets 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 the active pharmaceutical ingredient in EHP-101 has been deemed to not be a controlled substance by the US Drug Enforcement Administration (DEA) and the Canadian Controlled Substance Directorate.

About Emerald Health Pharmaceuticals Inc.

Emerald Health Pharmaceuticals is developing product candidates derived from cannabinoids for the treatment of central nervous system (CNS), autoimmune, fibrotic and other diseases. The Company has two families of new chemical entities, derived from synthetic cannabidiol (CBD) and cannabigerol (CBG), that it has chemically modified through rational drug design to affect validated receptors and pathways pertinent to targeted diseases. Its first drug product candidate, EHP-101, has completed a Phase 1 clinical study and is entering Phase 2 studies focused on treating systemic sclerosis and multiple sclerosis. Its second product candidate, EHP-102, is in preclinical development and is focused on treating Huntington’s disease and Parkinson’s disease. For more information, visit www.emeraldpharma.life or contact: info@emeraldpharma.life.

To the extent statements contained in this news release are not descriptions of historical facts regarding Emerald Health Pharmaceuticals Inc. they should be considered "forward-looking statements," as described in the private securities litigation reform act of 1995, that reflect management's current beliefs and expectations. You can identify forward-looking statements by words such as "anticipate," "believe," "could," "estimate," "expect," "forecast," "goal," "hope," "hypothesis," "intend," "may," "plan," "potential," "predict," "project," "should," "strategy," "will," "would," or the negative of those terms, and similar expressions that convey uncertainty of future events or outcomes. Forward-looking statements contained in this news release include, but are not limited to, statements regarding: (i) the success and timing of our product development activities and clinical trials; (ii) our ability to develop our product candidates; (iii) our plans to research, discover, evaluate and develop additional potential product, technology and business candidates and opportunities; (iv) the anticipated timing of clinical data availability; (v) our ability to meet our milestones; and (vi) our expectations regarding our ability to obtain and maintain intellectual property protection. Forward-looking statements are subject to known and unknown factors, risks and uncertainties that may cause actual results to differ materially from those expressed or implied by such forward-looking statements. Undue reliance should not be placed on forward-looking statements. We undertake no obligation to update any forward-looking statements. Emerald Health Pharmaceuticals' investigational drug products have not been approved or cleared by the FDA.

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