FDA Fast Tracks Investigational Treatment for Liver Fibrosis

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The Food and Drug Administration (FDA) has granted two fast track designations to ND-L02-s0201 (Nitto Denko Corporation) for the treatment of nonalcoholic steatohepatitis (NASH) liver fibrosis and hepatitis C virus (HCV) liver fibrosis, according to Nitto officials.

Fast track is a process designed to facilitate the development, and expedite the review of drugs to treat serious conditions and fill an unmet medical need.

Nitto Denko Corporation reported preliminary results from their ongoing Phase 1b/2 studies during The Liver Meeting 2015 held recently San Francisco. 

The Phase1b/2 clinical trial was designed to assess the safety, pharmacokinetics(PK), and biological activity of ND-L02-s0201, a targeted siRNA lipid nanoparticle (LNP), in patients with liver fibrosis. The interim results indicated that ND-L02-s0201 was well tolerated in advanced fibrosis patients and histological improvement of fibrosis was observed.

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