Health Canada Issues No Objection Letter to Initiate the ELEGANSE Trial With EPX-100 to Treat Lennox-Gastaut Syndrome
PARAMUS, N.J., February 16, 2022 (Newswire.com) - Epygenix Therapeutics, Inc. ("Epygenix"), a clinical stage biopharmaceutical company focused on rare and intractable genetic epilepsy, announced today that Health Canada issued a No Objection Letter (NOL) to proceed with the ELEGANSE trial for the treatment of Lennox-Gastaut Syndrome (LGS) with EPX-100 (Clemizole HCl). This ELEGANSE trial will evaluate the efficacy and safety of EPX-100 with patients suffering from LGS.
LGS is a rare epileptic encephalopathy presenting in childhood with intractable seizures. Approximately 48,000 children and adults in the United States currently suffer with LGS. Characterized by a triad of signs including multiple seizure types, slow spike-wave complexes on electroencephalographic (EEG) recordings, and impairment of cognitive function. Therapeutic options for LGS are desperately needed as seizure control with currently available treatments is not adequate.
"We are very pleased to receive a No Objection Letter (NOL) from Health Canada for our upcoming ELEGANSE study with EPX-100 for LGS patients. This NOL is one of the very important indication expansions and development milestones for the Company. Epygenix will continuously explore the safety and efficacy of EPX-100 as a novel treatment for LGS patients and other rare refractory genetic epilepsies. We are now poised to proceed with a clinical study in LGS patients with EPX-100 in the U.S. and Canada," says Dr. Hahn-Jun Lee, M.Sc., Ph.D., President and CEO of Epygenix Therapeutics, Inc.
Dr. Scott C. Baraban, Ph.D., professor and 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. "With the NOL from Health Canada for LGS, we continue to be the leader in moving drug candidates discovered in preclinical zebrafish models quickly toward clinical trials. We are excited to now expand this approach to include those suffering with LGS."
Alex Yang, J.D., LLM, President and CEO of Mstone Partners and Chair of the Board at Epygenix Therapeutics, also stated, "We are very pleased with the decision by Health Canada and hope that many drug-resistant epilepsy patients in Canada can carefully review the facts and benefits of EPX-100 and consider the enrollment for our clinical trials."
About Epygenix Therapeutics, Inc.
Epygenix Therapeutics, Inc. is a precision medicine-based biopharmaceutical company focused on discovering and developing drugs to treat rare and intractable genetic epilepsy in childhood, 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 that 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 seems to be via modulation of 5HT signaling pathways.
Hahn-Jun Lee, M.Sc., Ph.D.