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Neuren Pharmaceuticals Ltd Receives Fast Track Designation For NNZ-2566 In Rett Syndrome

Tuesday, 4 Jun 2013 09:40pm EDT 

Neuren Pharmaceuticals Ltd announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for Neuren’s program to develop NNZ-2566 in Rett Syndrome. Fast Track designation is designed to expedite the development and review of important new medicines that are intended to treat serious diseases and fill unmet medical needs. Neuren initiated a Phase II clinical trial in Rett Syndrome at Texas Children’s Hospital/Baylor College of Medicine in April 2013. The trial will enrol up to 60 adolescent and adult subjects, allowing for some early discontinuations, in order to meet a target of 48 who complete all scheduled doses and assessments. Enrolment and follow-up are expected to be complete in first half 2014 with top line results announced in second half 2014. NNZ-2566 is a synthetic analogue of a naturally occurring neuropeptide derived from IGF-1, a growth factor produced by brain cells. In animal models, NNZ-2566 inhibits neuroinflammation and normalises the function of microglia with consequent improvements in molecular, cellular, anatomic and behavioural outcomes. The Company intends to implement a Phase II clinical trial in Fragile X Syndrome and an additional Phase II trial with the oral form of NNZ-2566 in patients with concussion or mild TBI. 

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0.0050 +5.26%
22 Aug 2014