Noscira receives FDA approval for Tideglusib drug to treat PSP

Noscira, a Grupo Zeltia (ZEL.MC) subsidiary specialized in research and development of drugs to treat neurodegenerative diseases, has announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track status to its neuroprotector drug Tideglusib (ZentylorTM) to treat Progressive Supranuclear Palsy (PSP), a fast-advancing fatal degenerative brain disorder. A Phase II trial with Tideglusib (ZentylorTM) in PSP commenced in December 2009 and is currently in progress.

The FDA grants Fast Track status to facilitate the development and expedite the review of a drug to treat serious and potentially fatal diseases and to fill an unmet medical need. Fast Track status also enables a company to present rolling submissions, i.e. the various sections of a New Drug Application (NDA) may be presented and reviewed as they are completed, instead of following the regular model, which requires presentation of the complete application.

Belen Sopesen, CEO of Noscira: "Fast Track status is very positive for the company and is an incentive to continue advancing in the clinical development of Tideglusib (ZentylorTM) in Progressive Supranuclear Palsy, an illness for which patients have no treatment options."

On November 11, 2009, Noscira announced that the FDA and the EU had granted Tideglusib (ZentylorTM) orphan drug status for treating PSP. Tideglusib (ZentylorTM) is the only GSK-3 inhibitor in clinical development for PSP.