Press Release (ePRNews.com) - PARAMUS, N.J. - Oct 02, 2020 - Epygenix Therapeutics, Inc., a privately-held biopharmaceutical company developing precision medicine for Dravet Syndrome, announced today that the first patient has been enrolled in a Phase 2, 20-Week Multicenter, Randomized, Double-Blind, Placebo-Controlled, Proof of Concept Trial of EPX-100 as Adjunctive Therapy in Children with Dravet Syndrome. This Phase 2 study will confirm the efficacy and safety of EPX-100 with children suffering from Dravet Syndrome. The Company is now recruiting 24 patients to complete the study. Detailed study information is now available at clinicaltrials.gov. and dravetfoundation.org.
Dravet Syndrome is a rare, catastrophic, lifelong form of epilepsy that begins in the first year of life with frequent or prolonged seizures. Intellectual disability, behavioral abnormalities, gait and motor dysfunction, and increased mortality are commonly observed as the disease progresses. Patients suffer from life-threatening seizures that cannot be adequately controlled with available medications, and face an increased risk of SUDEP (Sudden Unexplained Death in Epilepsy), seizure-related accidents such as drowning, or infections.
Dr. Hahn-Jun Lee, M.Sc., Ph.D., President and CEO of Epygenix Therapeutics, Inc. stated, “We are very excited about the first patient enrollment, because this is one of the most significant clinical milestones for us. This opens the door to explore the efficacy for a better treatment option, and confirms our commitment to Dravet community.”
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 “First patient enrollment is an extremely exciting culmination and validation of our zebrafish-based drug discovery platform. Our early promise to find new drugs for children suffering with Dravet Syndrome in a rapid and efficient manner is now coming to fruition. Working with Epygenix to move these preclinical discoveries to the clinic, in only a few short years, is a prime example of our ‘aquarium-to-bedside’ philosophy.”
Alex Yang, J.D., LLM, President and CEO of Mstone Partners Hong Kong and Chair of the Board at Epygenix Therapeutics also stated that ”We are all very excited that we can finally test our drug for its efficacy with patients. Through this clinical trial, the Company hopes to quickly provide the best drug that is both safe and efficacious for DS community.”
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, -200, and -300. These candidates abolish convulsive behavior and electrographic seizure activity and were discovered in a zebrafish Dravet Syndrome model which mimics the human pathology and confirmed its validity by the human efficacy with EPX-200 and -300. For more information, please visit www.epygenix.com.
EPX-100 is a first-generation antihistamine and found to be a powerful suppressor of spontaneous convulsive behavior and electrographic seizures in zebrafish models for Dravet Syndrome. Its antiepileptic action, however, is not through a histaminergic mechanism of action, but via modulation of serotonin (5HT) signaling pathways. Its safety has been confirmed with the completed Phase I, Placebo-Controlled, Double-Blind, 2-Period Study to assess safety and pharmacokinetics of escalating single and multiple oral doses of EPX-100 in fasting healthy subjects and following a high-fat meal.
Hahn-Jun Lee, M.Sc., Ph.D.
Epygenix Therapeutics, Inc.