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IND application of ND-L02-s0201 allowed to proceed for idiopathic pulmonary fibrosis indication by the FDA / 2018/Mar/06
Nitto Denko Corporation (Headquarters: Osaka, Japan; President, CEO & COO: Hideo Takasaki; “Nitto”, hereafter) (6988: Tokyo), today announced that investigational new drug (IND) application for ND-L02-s0201, an RNAi-based investigational drug, for idiopathic pulmonary fibrosis (IPF) indication was allowed to proceed by the US Food and Drug Administration (FDA). Upon the IND allowance, Nitto plans to promptly initiate a Phase 2 study of ND-L02-s0201 for IPF. Nitto has been developing an RNAi-based drug for treating fibrosis in the liver and other organs since 2008, and in June 2013, Nitto initiated a clinical study for advanced liver fibrosis. In November 2016, Nitto signed a license agreement with Bristol-Myers Squibb (“BMS”, hereafter) giving BMS exclusive rights to develop the drug for liver diseases. BMS has exclusive options for additional licenses to Nitto’s IPF program and also for other fibrosis disease.
Under the slogan of “Innovation for Customers”, Nitto plans to continue expanding their business reach in the Green (Environment) / Clean (New Energy) / Fine (Life Sciences) domains in order to contribute to our customer’s value creation. Nitto continues to make significant efforts towards delivering new drugs for fibrosis and other intractable diseases to patients in need.
Idiopathic Pulmonary Fibrosis: IPF
Idiopathic pulmonary fibrosis (IPF) is a disease of unmet medical need that results in accumulation of collagen and thickening of interstitium, which is the tissue and space around the air sacs of the lungs, due to continuous inflammatory stimuli and lack of repair. IPF is associated with poor prognosis and is designated as one of the intractable diseases in Japan.
ND-L02-s0201 (BMS Code: BMS-986263)
It is an oligonucleotide drug using HSP47 (Heat Shock Protein 47) siRNA, which moderates collagen synthesis and secretion that causes fibrosis.
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