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Press Release 2015

2015/Nov/20

Nitto’s ND-L02-s0201, RNAi Anti-Fibrosis Drug for the Treatment of Liver Fibrosis Granted FDA Fast Track Designation

Nitto Denko Corporation (Nitto) reported preliminary results from their ongoing Phase 1b/2 studies during The Liver Meeting® 2015, 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.

In addition, ND-L02-s0201 was granted two FDA Fast Track designations for both NASH and HCV liver fibrosis indications in October. 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 continues to make significant efforts towards delivering new drugs for fibrosis and other intractable diseases to help patients in need.

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