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news.Turing Pharmaceuticals has announced dosing of the first group of subjects in the TUR-004 single ascending dose study, the first clinical study in a comprehensive program aimed at obtaining approval for the treatment of epileptic encephalopathies.
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Turing head of research and development Eliseo Salinas said: "I’m happy to report that TUR-004 was well tolerated and assessments continue as planned.
"This is certainly a small but significant milestone in a long path towards making this drug available for the patients who need it. Drug development is a very long path that takes hundreds of complicated small steps like this one," he added.
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. The present trial is the first in the Phase I clinical program for TUR-004, a new candidate for this group of disorders.
The trial is 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 healthy young adult subjects. TUR-004 has received Fast Tack Designation from the FDA.