Turing Pharmaceuticals AG Announces FDA Acceptance of Investigational New Drug Application and Fast Track Designation for TUR-004
Enrollment of Healthy Volunteers for a Phase I Clinical Study to begin in November 2015
ZUG, Switzerland, Oct. 23, 2015 /PRNewswire-USNewswire/ -- Turing Pharmaceuticals AG today announced that the U.S. Food and Drug Administration (FDA) has cleared the 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.
"Our research and development team has been working hard during the past six months to rapidly advance TUR-004 through the IND application process." said Eliseo Salinas, M.D., MSc, President of Research and Development at Turing. He added, "We are excited to move this therapy into the clinic with the aim of providing epileptic encephalopathies patients with new treatment options for these devastating disorders."
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."
The first study in the clinical program 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.
Fast Track designation is a program 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. Additionally, drugs that receive Fast Track designation are eligible for accelerated approval and priority review.
About TUR-004
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. Epileptic encephalopathies are a diverse group of severe epilepsy disorders in which uncontrolled epileptic activity contributes to a progressive decline in cognitive and motor function.
About Turing
Turing Pharmaceuticals AG is a privately-held biopharmaceutical company with offices in Zug Switzerland and New York, New York. Turing focuses on developing and commercializing innovative treatments for serious diseases and conditions across a broad range of therapeutic areas, for which there are currently limited or no treatment options. Products being developed include intranasal ketamine for a variety of mood and anxiety disorders and Syntocinon(r) (oxytocin nasal solution) for multiple indications. Daraprim (pyrimethamine) for the treatment of Toxoplasmosis in combination with sulfonamide and Vecamyl(r) (mecamylamine HCl tablets) for hypertension are Turing's first commercial products.
For more, visit www.turingpharma.com.
Safe Harbor
In addition to historical facts or statements of current condition, this press release contains forward-looking statements within the meaning of "Safe Harbor" provisions of The Private Securities Litigation Reform Act of 1995, including statements regarding the initiation of product development activities, including but not necessarily limited to clinical trials. Forward-looking statements provide Turing Pharmaceuticals' current expectations and forecasts of future events. Turing Pharmaceuticals' performance and financial results could differ materially from those reflected in these forward-looking statements due to general financial, economic, regulatory and political conditions affecting the biotechnology and pharmaceutical industries. Given these risks and uncertainties, any or all of these forward-looking statements may prove to be incorrect. Therefore, you should not rely on any such factors or forward-looking statements. Turing Pharmaceuticals undertakes no obligation to update publicly any forward-looking statements.
SOURCE Turing Pharmaceuticals AG
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