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After Daraprim, Turing Pharma submits first in-house candidate to FDA

Published on 06/10/15 at 09:17am

Turing Pharma may have been on the end of some less-than-favourable media coverage in recent weeks, but the company is moving on from the Daraprim story with the submission of its first in-house drug candidate to the US FDA.

The company says TUR-004- submitted to the authority on September 22- and is intended for use as an adjunctive therapy for refractory generalised seizures in patients with epileptic encephalopathies.

The first study in the clinical program will be a randomised, double-blind, placebo-controlled, single ascending dose study to evaluate the safety, tolerability and pharmacokinetics of an oral formulation of TUR-004 in healthy adults.

Epileptic encephalopathies are a diverse group of severe epilepsy disorders that manifest in early age, in which uncontrolled epileptic activity contributes to a progressive decline in cognitive and motor function. Individuals with epileptic encephalopathies face a higher incidence of sudden unexplained death, status epilepticus and severely diminished quality of life.

“We are excited about the potential use of TUR-004 for helping people with this severe form of epilepsy,” says Eliseo Salinas, president of research and development. “We feel very strongly that clinical studies of TUR-004 will lead to the availability of TUR-004 and help to improve patients’ lives.”

Martin Shkreli, founder and CEO of Turing Pharmaceuticals, said the new submission would be just the first of several applications in the next year.  He has previously claimed that the price-hike of Daraprim was unfortunate but necessary in order to fund research into new, more effective treatments.

He comments: “TUR-004 is the first of multiple investigational new drug applications we expect to file in the next twelve months as a result of our focused research and development programs.”

Joel Levy

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