PARAMUS, N.J., Jan. 27, 2020 /PRNewswire/ -- Epygenix Therapeutics, Inc., a privately held biopharmaceutical company developing precision medicine for Dravet Syndrome, announced today that the Company successfully completed a 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. This Phase 1 study successfully confirmed that EPX-100 is safe, well-tolerated, and does not show any clinically significant abnormalities among equal numbers of male and female subjects (N=12 each). Pharmacokinetics were dose-proportional and consistent with preclinical animal studies. Based on results from this Phase 1 study, Epygenix will immediately initiate EPX-100 Phase 2 efficacy studies with Dravet Syndrome patients in the U.S. and Australia. The Company is diligently preparing these clinical studies with the team of Greenlight Clinical.
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 successful completion of EPX-100 Phase 1 studies because we were able to confirm the safety and tolerance of EPX-100 in humans and obtain invaluable PK information for upcoming Phase 2 studies. Indeed, this will be a big momentum for EPX-100 development for the treatment of Dravet patients."
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 "The results of these Phase 1 trials confirm a safe EPX-100 profile already predicted from preclinical studies. We are excited to now see this compound, first discovered in a zebrafish model of Dravet, move into human efficacy trials."
Alex Yang, J.D., LLM, President and CEO of Mstone Partners Hong Kong and Chairman of the Board at Epygenix Therapeutics, also stated that "We are very encouraged by this momentous milestone towards human efficacy trials after robust safety confirmation which will put us in a very favorable position. We may also look for potential partnering to quickly expand indications to Lennox-Gastaut Syndrome and other treatment-resistant epilepsies to help many patients worldwide with unmet needs."
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, EPX-200, and EPX-300. These drug 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 EPX-300. For more information, please visit www.epygenix.com.
EPX-100 is a first-generation antihistamine that was safely used to treat itch between 1950 and 1970. EPX-100 was found to be a powerful suppressor of spontaneous convulsive behavior and electrographic seizures in zebrafish models for Dravet Syndrome. EPX-100 antiepileptic action, however, is not through a histaminergic mechanism of action but via modulation of serotonin (5HT) signaling pathways.