Emerald Health Pharmaceuticals’ Novel Drug Candidate Demonstrates Significant Anti-inflammatory and Anti-fibrotic Activity in Multi-organ Fibrosis Preclinical Model

Data published in peer-reviewed journal show ability of EHP-101 to prevent cardiac, renal, pulmonary and dermal fibrosis

SAN DIEGO, CA, Dec. 02, 2021 (GLOBE NEWSWIRE) -- Emerald Health Pharmaceuticals Inc. (EHP or the Company), a clinical-stage biopharmaceutical company developing a new class of medicines to treat neurodegenerative, autoimmune and other diseases with unmet medical needs, has announced the publication of a scientific article in the peer-reviewed journal, Biomedicine & Pharmacotherapy, highlighting a new study providing additional data supporting the potential of EHP’s patented, first-in-class drug candidate, EHP-101, to treat fibrotic diseases, including cardiac fibrosis and systemic sclerosis (SSc). EHP is currently enrolling patients dosed with oral EHP-101 in a Phase IIa clinical trial for SSc (NCT04166552).

Titled “EHP-101 alleviates angiotensin II-induced fibrosis and inflammation in mice,” the scientific paper was co-authored by Eduardo Muñoz, MD, PhD (EHP’s Chief Scientific Officer), Giovanni Appendino, PhD (Scientific Advisor to EHP), as well as other senior scientists from the Company.

The new study demonstrated significant antifibrotic activity in a murine model of multi-organ fibrosis and demonstrates that EHP-101 prevents and inhibits cardiac inflammation and fibrosis as well as renal, pulmonary and dermal fibrosis, all of which are associated with several autoimmune and fibrotic diseases with unmet medical needs.

The purpose of the study was to examine the effects of EHP-101 on cardiac and other organ fibrosis induced by angiotensin II, which is implicated in the progression of myocardial fibrosis. Increased serum levels of angiotensin II are seen in patients with cardiovascular diseases that are associated with myocardial fibrosis, including atherosclerosis, hypertension, cardiac hypertrophy and heart failure. Moreover, cardiac fibrosis is preceded by immune-activated cell infiltration leading to inflammation. In the study, EHP-101 was shown to reduce fibrotic markers and prevent multiple organ fibrosis, including cardiac fibrosis, and reduce the infiltration of macrophages and T cells in cardiac tissue.

“This study represents a positive continuation of what EHP-101 has demonstrated consistently with its unique ability to address key disease factors associated with the pathophysiology of fibrotic diseases through its multi-factorial mechanism of action,” said Jim DeMesa, MD, MBA, President and CEO of EHP. “The results of this new study indicate that EHP-101 could offer new opportunities in the treatment of cardiac fibrosis and other fibrotic diseases.”

Eduardo Muñoz, MD, PhD, Chief Scientific Officer of EHP, added, “systemic sclerosis causes vascular damage, painful inflammation and progressive fibrosis of the skin and internal organs, and we have shown previously and confirmed in this study that EHP-101 has potent anti-inflammatory and antifibrotic activities. EHP-101 activates biological receptors and physiological pathways in the body, such as PPARγ and CB₂ receptors, as well as the HIF pathway via B55a/PP2A, which are key targets of the disease. This activity makes EHP-101 a strong product candidate for the potential treatment of SSc - a disease with multiple biological components - because of its unique mechanism of action.”

EHP is also in the process of initiating Phase II clinical development with EHP-101 for multiple sclerosis (NCT04909502).

About Systemic Sclerosis, Multiple 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 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 dcSSc 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.

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, difficulty chewing, swallowing, and speaking. Currently, approved MS drugs are all primarily intended to relieve symptoms and reduce the rate of relapses, but none are curative.

EHP-101 is an oral formulation of VCE-004.8, which provides dual peroxisome proliferator-activated receptor gamma (PPARγ) and cannabinoid receptor type 2 (CB₂) agonist activity. Both receptors are therapeutic targets for SSc. VCE-004.8 also activates the subunit B55a of the protein phosphatase PP2A that is implicated in 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.

About Emerald Health Pharmaceuticals Inc.

Emerald Health Pharmaceuticals is developing novel product candidates for the treatment of CNS, autoimmune, and other diseases. The company has two families of patented new chemical entities that it has created through rational drug design to affect validated receptors and pathways in the body which are pertinent to targeted diseases. Its first drug product candidate, EHP-101, has entered into Phase 2 clinical development 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, as well as Fast-Track status by the US FDA 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 or contact info@emeraldpharma.com.

Forward Looking Statements

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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