SAN DIEGO, CA, Oct. 07, 2022 (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, has completed enrolling the first two cohorts of nine patients each of its Phase II clinical study of the Company’s lead product candidate, EHP-101, an oral formulation of a patented new molecule. This study is assessing the effectiveness of EHP-101 in treating patients suffering from systemic sclerosis (“SSc”). After completing drug dosing and monitoring for each patient as per the study protocol, EHP expects to report interim results from the study in early 2023.
This SSc Phase 2a trial is a double-blind, placebo-controlled study to evaluate the safety, tolerability, pharmacokinetics and preliminary efficacy in patients with SSc. SSc is a disease characterized by rapid fibrosis in the skin and internal organs. There are no approved products for treatment.
In the first two cohorts of the Company’s SSC Phase 2a trial of 18 patients suffering from SSc, the Company is administering two doses to each patient, first once daily and then twice daily. The treatment lasts for 12 weeks, with a 4-week follow-up. Further details about the study design can be found on ClinicalTrials.gov: NCT04166552.
The Safety Review Committee overseeing the SSc Phase 2a clinical trial will meet in the fourth quarter of 2022 to assess the safety and pharmacokinetics data for the completed cohorts to determine whether to allow the clinical trial to progress to cohorts 3 and 4.
EHP submitted a protocol amendment to the FDA to increase the size of cohorts 3 and 4 from 18 to 48 subjects and to increase the treatment duration from 12 weeks to 24 weeks. The Company applied for this amendment to create a pathway to advance directly into a Phase 3 clinical trial of EHP-101 in patients suffering from SSc once the Phase 2a trial is completed, rather than having to first conduct a Phase 2b before continuing to a Phase 3 trial. As per the FDA’s review protocol, since the FDA has not responded to the amendment within the mandated 30-day period the Company is now authorized to carry out these changes to cohorts 3 and 4 of the SSc trial.
“We are pleased to reach the halfway point of EHP’s first Phase 2 trial, and doing so in SSc, a disease with no effective treatments,” said Alain Rolland, Pharm.D., Ph.D., COO of EHP. “EHP-101’s mechanism of action is first-in-class and offers the prospect of important therapeutic effects for patients. We look forward to evaluating the interim analysis of the first two cohorts of this Phase 2 trial in early 2023.”
About Systemic Sclerosis and EHP-101
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 these 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 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.
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, which provides dual peroxisome proliferator-activated receptor gamma and cannabinoid receptor type 2 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 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.
EHP is developing novel product candidates for the treatment of CNS, autoimmune, and other diseases with unmet medical needs. 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, is in a Phase 2a study for the treatment of systemic sclerosis, a severe form of scleroderma, and has met regulatory requirements to start a Phase II study for 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. 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
