Health Canada Grants No Objection Letter to Epygenix Therapeutics to Proceed With ARGUS Trial for the Treatment of Dravet Syndrome
PARAMUS, N.J., Aug. 2, 2021 - Epygenix Therapeutics, Inc., a clinical stage biopharmaceutical company focused on rare and intractable genetic epilepsy, is pleased to announce that the company's ARGUS trial with EPX-100 (Clemizole Hydrochloride) in patients with Dravet syndrome (DS) has been approved by Health Canada. The No Objection Letter (NOL) from Health Canada is equivalent to a 'May You Proceed' letter from the FDA. It provides the acknowledgement of EPX-100's drug candidacy and the authority to proceed with a 20-Week Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial of EPX-100 as Adjunctive Therapy.
"We are very grateful to receive the NOL from Health Canada to proceed with our ARGUS trial. This NOL will allow us to enroll patients with Dravet syndrome in Canada, and to efficiently test the safety and efficacy of EPX-100 in them. Our team is now poised to open multiple clinical sites across Canada and enroll patients to test EPX-100," says Dr. Hahn-Jun Lee, M.Sc., Ph.D., President and CEO of Epygenix Therapeutics, Inc.
Dravet Syndrome is a rare, catastrophic, lifelong form of epilepsy which begins in the first year of life with frequent or prolonged seizures. Intellectual disability, behavioral abnormalities, gait and motor dysfunction, and increased mortality are commonly observed as the disease progresses. Patients suffer from life-threatening seizures that cannot be adequately controlled with available medications, and face an increased risk of SUDEP (Sudden Unexplained Death in Epilepsy), seizure-related accidents such as drowning, or infections. In most cases, the disease is caused by heterozygous de novo mutation or deletion of SCN1A, a gene encoding a brain voltage-gated sodium channel (Nav1.1).
Dr. Scott C. Baraban, Ph.D., Professor & William K. Bowes Jr. Endowed Chair in Neuroscience Research at UCSF and Chair of the Scientific Advisory Board at Epygenix Therapeutics, Inc. issued a joint comment that "Discovered here in our lab using a well-established model of DS in zebrafish, we are excited to see EPX-100 moving forward as a novel drug option for patients suffering from this devastating disease. The opportunity to perform ARGUS trial in Canada brings us one step closer toward a new treatment option for Dravet syndrome beyond US and eventually worldwide."
Alex Yang, J.D., LLM, President and CEO of Mstone Partners and Chair of the Board at Epygenix Therapeutics also stated that "Despite challenges with the pandemic, our team is highly motivated to quickly test our drugs for Dravet patient community by expanding our clinical trial sites beyond the US borders. We hope to enroll more patients with our ARGUS trial as soon as possible."
About Epygenix Therapeutics, Inc.
Epygenix Therapeutics, Inc. is a clinical stage biopharmaceutical company focused on developing drugs to treat rare and intractable genetic epilepsy, such as Dravet Syndrome. Epygenix is currently focused on developing EPX-100, EPX-200, and EPX-300. These drug candidates abolish convulsive behavior and electrographic seizure activity and were discovered in a zebrafish Dravet Syndrome model which mimics the human pathology. For more information, please visit www.epygenix.com.
EPX-100 is a first-generation antihistamine which was safely used to treat itch between 1950 and 1970. EPX-100 was found to be a powerful suppressor of spontaneous convulsive behavior and electrographic seizures in zebrafish models for Dravet Syndrome. EPX-100 antiepileptic action, however, is not through a histaminergic mechanism of action, but via modulation of serotonin (5HT) signaling pathways.
Hahn-Jun Lee, M.Sc., Ph.D.