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Epygenix Therapeutics Announces FDA Acceptance of IND to Initiate a Clinical Trial of EPX-100 to Treat Lennox-Gastaut Syndrome

Monday, August 30, 2021

Epygenix Therapeutics, Inc., a clinical stage biopharmaceutical company focused on rare and intractable genetic epilepsy, announced today that the U.S. Food and Drug Administration ("FDA") has accepted the Company's Investigational New Drug ("IND") application to initiate A 20-Week Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial of EPX-100 (Clemizole Hydrochloride) as Adjunctive Therapy in Patients with Lennox-Gastaut Syndrome.

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 with the FDA acceptance of our IND, because this is one of the significant development milestones for the Company to begin its expansion to other rare genetic epilepsies. We will explore the efficacy of EPX-100 as a novel treatment for those patients suffering with refractory epilepsies. Our team is now poised to proceed with a clinical study of EPX-100 in LGS patients," says Dr. Hahn-Jun Lee, M.Sc., Ph.D., president and CEO of Epygenix Therapeutics, Inc.

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 "With IND acceptance 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 that "Epygenix is committed to provide the best-in-class drug options by expanding indications that are safe, effective, and patient-friendly to cover a broad category of refractory genetic epilepsies. We are very excited to achieve another development milestone towards commercialization as we plan to expand further into other rare epileptic indications."

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