SAN DIEGO, CA, Jan. 13, 2020 (GLOBE NEWSWIRE) -- Emerald Health Pharmaceuticals Inc. (EHP), a clinical-stage biotechnology company developing medicines based on cannabinoid science, announced today that the U.S. Food and Drug Administration (FDA) has cleared its investigational new drug (IND) application for EHP-101, an oral product candidate of a patented new chemical entity for the treatment of patients with systemic sclerosis (SSc), a severe form of scleroderma. This IND clearance allows the initiation of a Phase 2 study in the United States. The study is planned to be conducted at multiple centers in the United States and site selection activities are currently underway.
“We are excited to be able to start the expansion of our Phase 2 clinical trial of EHP-101 for the treatment of systemic sclerosis,” said Jim DeMesa, MD, President & CEO of EHP. “The novel multi-pronged mechanism of action and the results of our preclinical and Phase 1 studies give us great confidence in the ability for EHP-101 to succeed in Phase 2. With the initiation of our Phase 2 clinical study in systemic sclerosis currently underway in Australia, and now with the addition of the U.S. with our cleared IND, we are on track to start getting data by the end of 2020.”
Recently, the company successfully completed its first-in-human Phase 1 clinical study of EHP-101 evaluating the safety, pharmacokinetics, pharmacodynamics and exploratory biomarkers in healthy volunteers in Australia as a randomized, double-blind, placebo-controlled study.
The Company plans to announce the full data from the Phase 1 study in February at a prestigious medical meeting.
About Systemic Sclerosis and EHP-101
Systemic sclerosis (SSc), a 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. 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. The disease is more common in adults, with an estimated 80,000 - 100,000 people affected in the U.S. 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 and early diagnosis will be critical to help reduce the symptoms of SSc and prevent further damage to the body.
EHP is currently developing two drug product candidates from its portfolio of cannabinoid derivatives, one derived from CBD for multiple sclerosis and systemic sclerosis (EHP-101) and one derived from cannabigerol (CBG), EHP-102, for Huntington’s disease and Parkinson’s disease. EHP-101 is an oral formulation of an aminoquinone derivative of cannabidiol 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 HIF pathway, expanding the rationale for its development as a novel SSc drug. EHP has received Orphan Drug Designation for EHP-101 in SSc from both the FDA and EMA and the active pharmaceutical ingredient in EHP-101, a CBD-derivative, has been deemed to not be a controlled substance by the U.S. Drug Enforcement Administration (DEA).
About Emerald Health Pharmaceuticals Inc.
Emerald Health Pharmaceuticals is developing product candidates derived from cannabinoids for the treatment of CNS, autoimmune, and other diseases. The Company has two families of new chemical entities, derived from synthetic cannabidiol (CBD) and cannabigerol (CBG), that it has 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 one, EHP-102, is in preclinical development and is focused on treating Huntington’s disease and Parkinson’s disease. For more information, visit http://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.