updated: Jan 27, 2020
January 27, 2020(Newswire.com) –
Epygenix Therapeutics, Inc., a privately held biopharmaceutical corporation producing precision drugs for Dravet Syndrome, declared now that the Enterprise successfully completed a Phase I, Placebo-Managed, Double-Blind, 2-Time period Research to assess protection and pharmacokinetics of escalating solitary and multiple oral doses of EPX-one hundred in fasting healthier subjects and subsequent a superior-fat meal. This Phase 1 study successfully verified that EPX-one hundred is protected, well-tolerated, and does not exhibit any clinically substantial abnormalities among equal quantities of male and female subjects (N=twelve every single). Pharmacokinetics were dose-proportional and steady with preclinical animal reports. Based on final results from this Phase 1 review, Epygenix will quickly initiate EPX-one hundred Period 2 efficacy reports with Dravet Syndrome clients in the U.S. and Australia. The Enterprise is diligently preparing these medical reports with the staff of Greenlight Medical.
Dravet Syndrome is a exceptional, catastrophic, lifelong type of epilepsy that begins in the first calendar year of life with frequent or prolonged seizures. Intellectual incapacity, behavioral abnormalities, gait and motor dysfunction, and amplified mortality are typically observed as the condition progresses. Patients endure from lifestyle-threatening seizures that can not be adequately managed with obtainable drugs and encounter an amplified threat of SUDEP (Sudden Unexplained Loss of life in Epilepsy), seizure-similar incidents this kind of as drowning, or infections.
Dr. Hahn-Jun Lee, M.Sc., Ph.D., President and CEO of Epygenix Therapeutics, Inc., said, “We are incredibly thrilled about the thriving completion of EPX-one hundred Period 1 reports mainly because we were equipped to confirm the protection and tolerance of EPX-one hundred in human beings and obtain invaluable PK data for forthcoming Period 2 reports. Certainly, this will be a significant momentum for EPX-one hundred development for the procedure of Dravet clients.”
Dr. Scott C. Baraban, Ph.D., Professor & William K. Bowes Jr. Endowed Chair in Neuroscience Analysis at UCSF and Chair of the Scientific Advisory Board at Epygenix Therapeutics, Inc. issued a joint remark that “The final results of these Period 1 trials ensure a protected EPX-one hundred profile currently predicted from preclinical reports. We are thrilled to now see this compound, first found in a zebrafish design of Dravet, move into human efficacy trials.”
Alex Yang, J.D., LLM, President and CEO of Mstone Companions Hong Kong and Chairman of the Board at Epygenix Therapeutics, also said that “We are incredibly encouraged by this momentous milestone towards human efficacy trials after strong protection affirmation which will set us in a incredibly favorable place. We might also glance for prospective partnering to promptly expand indications to Lennox-Gastaut Syndrome and other procedure-resistant epilepsies to help numerous clients globally with unmet demands.”
About Epygenix Therapeutics, Inc.
Epygenix Therapeutics, Inc. is a precision drugs-primarily based biopharmaceutical corporation targeted on finding and producing prescription drugs to address exceptional and intractable genetic epilepsy in childhood, this kind of as Dravet Syndrome. Epygenix is now targeted on producing EPX-one hundred, EPX-200, and EPX-three hundred. These drug candidates abolish convulsive habits and electrographic seizure activity and were found in a zebrafish Dravet Syndrome design which mimics the human pathology and verified its validity by the human efficacy with EPX-200 and EPX-three hundred. For far more data, you should go to www.epygenix.com.
About EPX-one hundred
EPX-one hundred is a first-technology antihistamine that was safely and securely used to address itch among 1950 and 1970. EPX-one hundred was identified to be a impressive suppressor of spontaneous convulsive habits and electrographic seizures in zebrafish types for Dravet Syndrome. EPX-one hundred antiepileptic action, nevertheless, is not by way of a histaminergic system of action but by using modulation of serotonin (5HT) signaling pathways.
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Hahn-Jun Lee, M.Sc., Ph.D.
Source: Epygenix Therapeutics, Inc.