Nitto Denko Corporation (Headquarters: Osaka, Japan; President, CEO & COO: Hideo Takasaki; “Nitto”, hereafter) (6988: Tokyo), today announced that they initiated Phase 2 clinical study of ND-L02-s0201, an HSP47 siRNA drug, for idiopathic pulmonary fibrosis (IPF) in Japan. This study is multi-regional clinical study that has already initiated in the United States and Europe.

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.

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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.

It is an oligonucleotide drug using HSP47 (Heat Shock Protein 47) siRNA, which moderates collagen synthesis and secretion that causes fibrosis.