FDA approves Epygenix to start clinical trial for epilepsy treatment

  • The company is set to test the efficacy of its EPX-100 in Lennox-Gastuat Syndrome patients.
  • About 48,000 adults and children in the United States currently suffer from LGS.

Clinical-stage biopharmaceutical firm Epygenix Therapeutics Inc., which is focused on developing drugs to treat rare genetic epilepsy, has recently announced that it received U.S. Food and Drug Administration (FDA) approval for its Investigational New Drug (IND) application.

The company can now commence a 20-week multicenter, double-blind, randomized, placebo-controlled trial of EPX-100 (Clemizole Hydrochloride) as adjunctive therapy for patients with Lennox-Gastuat Syndrome (LGS).

For the unversed, LGS is a rare epileptic encephalopathy that causes intractable seizures in children. It is characterized by a triad of symptoms that include numerous seizure types, delayed spike-wave complexes on electroencephalographic (EEG) recordings, and cognitive function impairment. As seizure control with currently existing treatments is not adequate, new therapeutic options for LSG are highly required.

Dr. Hahn-Jun Lee, President, and CEO of Epygenix expressed that they are glad the FDA approved their IND since it is one of the key development milestones for the firm as it prepares to expand into other rare genetic epilepsies. They are ready to start a clinical trial of EPX-100 in LGS patients, he said.

Alex Yang, Chair of the Board at Epygenix Therapeutics, stated that Epygenix provides the best-in-class drug options by expanding safe, effective, and patient-friendly indications to cover a wide range of refractory genetic epilepsies. They are pleased to achieve another development milestone on the road to commercialization and plan to extend into other rare epileptic indications, he continued.

Epygenix is currently working on the EPX-100, -200, and -300 drugs. These candidates, previously found in a zebrafish Dravet Syndrome model which imitates human pathology, suppress convulsive behavior and electrographic seizure activity.

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