Epygenix Therapeutics announces FDA acceptance of IND to initiate clinical trial of EPX-100 to treat LGS

Epygenix Therapeutics announced yesterday that the US Food and Drug Administration (FDA) has accepted the company’s Investigational New Drug (IND) application to initiate a 20-week multi-centre, randomised, double-blind, placebo-controlled trial of EPX-100 (Clemizole Hydrochloride) as adjunctive therapy in patients with Lennox-Gastaut Syndrome, the company notified in a statement.

It also informed that LGS is a rare epileptic encephalopathy presenting in childhood with intractable seizures. Approximately 48,000 children and adults in the US currently suffer from LGS. Characterised 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 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 from refractory epilepsies. Our team is now poised to proceed with a clinical study of EPX-100 in LGS patients,” said Dr Hahn-Jun Lee, MSc, PhD, President and CEO, Epygenix Therapeutics.

Dr Scott C Baraban, PhD, Professor and William K Bowes Jr, endowed Chair in Neuroscience Research at UCSF and Chair, Scientific Advisory Board, Epygenix Therapeutics, issued a joint comment saying, “With IND acceptance for LGS, we continue to be the leader in moving drug candidates discovered in pre-clinical zebrafish models quickly towards clinical trials. We are excited to now expand this approach to include those suffering from LGS.”

Alex Yang, JD, LLM, President and CEO, Mstone Partners and Chair of the Board, Epygenix Therapeutics, also stated, “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 excited to achieve another development milestone towards commercialisation as we plan to expand further into other rare epileptic indications.”