First-in-class product candidate in Phase 2 clinical development now has Fast Track and Orphan designations
SAN DIEGO, CA, March 03, 2020 (GLOBE NEWSWIRE) -- Emerald Health Pharmaceuticals Inc. (EHP), a clinical-stage company developing medicines based on cannabinoid science, has been granted Fast Track designation from the US Food and Drug Administration (FDA) for its lead clinical-stage product candidate, EHP-101, for the treatment of systemic sclerosis (SSc), a severe form of scleroderma.
EHP is currently initiating a Phase 2 clinical study for systemic sclerosis in Australia, New Zealand and the United States with EHP-101, an oral formulation of a patented, synthetic new chemical entity derived from cannabidiol (CDB). EHP previously received Orphan Drug designation in the US and EU for EHP-101 in the treatment of systemic sclerosis.
“This Fast Track designation is another positive step for us in our development of this much-needed therapy,” said Jim DeMesa, MD, President & CEO of Emerald Health Pharmaceuticals. “With a Phase 2 study being initiated, this Fast Track designation, along with the previously granted Orphan designations, gives us a regulatory path to most efficiently achieve our clinical development plans.”
Fast Track is an FDA regulatory designation to facilitate the development and expedite the review of drugs to treat serious conditions and fill an unmet medical need. The purpose is to get important new drugs to the patient earlier. Fast Track addresses a broad range of serious conditions. A drug that receives Fast Track designation is eligible for some or all of the following:
- More frequent meetings with FDA to discuss the drug's development plan and ensure collection of appropriate data needed to support drug approval
- More frequent written communication from FDA about such things as the design of the proposed clinical trials and use of biomarkers
- Eligibility for Accelerated Approval and Priority Review, if relevant criteria are met
- Rolling Review, which means that a drug company can submit completed sections of its New Drug Application (NDA) for review by FDA, rather than waiting until every section of the NDA is completed before the entire application can be reviewed. NDA review usually does not begin until the drug company has submitted the entire application to the FDA.
About Systemic Sclerosis and EHP-101
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. 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-101 is an oral formulation of a novel aminoquinone synthetic derivative of cannabidiol (CBD) endowed 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 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 from both the FDA and EMA and the active pharmaceutical ingredient in EHP-101 has been deemed to not be a controlled substance by the US Drug Enforcement Administration (DEA).
About Emerald Health Pharmaceuticals Inc.
Emerald Health Pharmaceuticals is developing novel product candidates derived from cannabinoids for the treatment of 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 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 initially on treating systemic sclerosis (a severe form of scleroderma) and multiple sclerosis. Its second product candidate, EHP-102, is in preclinical development and is focused initially on treating Huntington’s disease and Parkinson’s disease. EHP has received Orphan Drug designation in the US and EU for EHP-101 in systemic sclerosis and EHP-102 in Huntington’s disease. For more information, visit http://www.emeraldpharma.life or contact EHP at 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.