Epygenix Therapeutics Initiates Phase 2 Study for Dravet Syndrome With EPX-100
PARAMUS, N.J., Sept. 17, 2020 - Epygenix Therapeutics, Inc., a privately held biopharmaceutical company developing precision medicine for Dravet Syndrome, announced today that the Company initiated 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 patients for this clinical study, collaborated with GreenLight Clinical, a global, full-service CRO. Detailed study information is now available online at clinicaltrial.gov. and dravetfoundation.org.
Dravet Syndrome is a rare, catastrophic, lifelong form of epilepsy which 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 initiation of EPX-100 Phase 2 studies because we can access patients one step closer with this novel therapeutic intervention for Dravet Syndrome. This is a huge milestone achievement of the Company toward the next jump."
Dr. Sasi Suda, M.D., CEO of GreenLight Clinical, issued a joint comment that "We are very excited to collaborate with Epygenix. This Phase 2 study will bring the effective treatment of Dravet Syndrome a step closer. Our medical affairs team will be fully embedded with Epygenix to leverage product knowledge and vision with best-in-class clinical trial intelligence. Epygenix shares our patient-centric approach, and together we are committed to a successful outcome of this trial."
Alex Yang, J.D., LLM, President and CEO of Mstone Partners Hong Kong and Chair of the Board at Epygenix Therapeutics, also stated that Epygenix is committed to bringing both safe and effective drugs based on exceptional science. Given its excellent safety profile, this phase 2 studies will potentially help cement the position for EPX-100 as best-in-class in treating these types of refractory epilepsy disorders.
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.