FDA Fast Tracks Investigational Tx for Liver Fibrosis
Nitto Denko announced that the Food and Drug Administration (FDA) has granted two Fast Track designations to ND-L02-s0201 for the treatment of nonalcoholic steatohepatitis (NASH) liver fibrosis and hepatitis C virus (HCV) liver fibrosis.
The company recently presented preliminary results of ongoing Phase 1b/2 studies for ND-L02-s0201 at the The Liver Meeting® 2015 in San Francisco, California. The trials were designed to assess the safety, pharmacokinetics (PK), and biological activity of ND-L02-s0201 in patients with liver fibrosis. It was found that ND-L02-s0201 demonstrated histological improvement of fibrosis and tolerable safety profile in patients with advanced fibrosis.
ND-L02-s0201 is a targeted siRNA lipid nanoparticle (LNP).
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