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US FDA accepts Turing Pharma's IND application and Fast Track Designation for TUR-004 to treat epileptic encephalopathies

 

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The US Food and Drug Administration (FDA) has cleared Turing Pharmaceuticals AG's Investigational New Drug (IND) application for TUR-004 in the treatment of epileptic encephalopathies. In addition, TUR-004 has been granted Fast Track designation.

Turing will be initiating a phase 1 study in young healthy volunteers to evaluate the safety, tolerability and pharmacokinetics of oral doses of TUR-004 in the coming weeks. The first study in the clinical programme will be a randomized, double-blind, placebo-controlled, single ascending dose study to evaluate the safety, tolerability and pharmacokinetics of an oral formulation of TUR-004 in young healthy adult subjects.

Martin Shkreli, founder and chief executive officer of Turing Pharmaceuticals said, "With our first investigational candidate moving into the clinic, this is a very exciting moment at Turing Pharmaceuticals. We are pleased that FDA has granted Fast Track status for TUR-004 providing for an accelerated development and regulatory review pathway."

Fast Track designation is a programme designed to facilitate development, and expedite the review of drugs to treat serious conditions and fill unmet medical needs. This designation allows for companies to submit New Drug Applications (NDA) or Biologics License Applications (BLA) on a rolling basis, expediting the FDA review process, and benefiting from more frequent communication with the FDA to discuss all aspects of clinical development.

TUR-004 is being developed as adjunctive therapy for refractory generalized seizures in patients with epileptic encephalopathies. Individuals with epileptic encephalopathies face a higher incidence of sudden unexplained death, status epilepticus and severely diminished quality of life.


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