Epygenix Therapeutics, Inc., a precision medicine-based biopharmaceutical company, announced that they have received an Investigational New Drug Application (IND) approval from the U.S. Food and Drug Administration (FDA) for the treatment of patients with Dravet syndrome.
EXP-100 is a first-generation antihistamine safely used to treat itch in the 1950-1960s. It was found to be a suppressor of spontaneous convulsive behavior and electrographic seizures in zebrafish disease models for Dravet Syndrome. The antiepileptic action of EPX-100 is not through a histaminergic mechanism of action, but acts via modulation of seratonin (5HT) signaling pathways.
Epygenix will start a Phase I, placebo-controlled, double-blind, 2-period study to assess the safety and pharmacokinetcs of escalating oral doses of EPX-100 in fasting healthy subjects following a high-fat meal. Immediately following Phase I studies, Phase 2 studies will be initiated with Dravet syndrome patients. For updates and more information, visit Epygenix’s website here.