Epileptic Encephalopathy Tx Granted Fast Track Designation
Turing Pharmaceuticals announced that the Food and Drug Administration (FDA) has granted Fast Track designation to their investigational agent, TUR-004, for the treatment of epileptic encephalopathies.
Turing will soon be initiating the first study in the clinical program, a Phase 1, randomized, double-blind, placebo-controlled, single ascending dose study to evaluate the safety, tolerability and pharmacokinetics of oral doses of TUR-004 in young healthy adult subjects.
TUR-004 is being developed as adjunctive therapy for refractory generalized seizures in patients with epileptic encephalopathies, a diverse group of severe epilepsy disorders in which uncontrolled epileptic activity contributes to a progressive decline in cognitive and motor function.
For more information visit TuringPharma.com.