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Press Release 2023


HSP47 siRNA drug ND-L02-s0201 for fibrosis

Results from Phase 2 Clinical Trial of ND-L02-s0201 for the Treatment of Idiopathic Pulmonary Fibrosis

Nitto Denko Corporation (Headquarters: Osaka, Japan: President: Hideo Takasaki) (“Nitto”) today announced that ND-L02-s0201 did not show the expected efficacy in the Phase 2 clinical trial for the treatment of Idiopathic Pulmonary Fibrosis*1, although it was well safe and tolerable. These results were shared and discussed with Bristol Myers Squibb Company (Headquarters: New York City, New York, USA; CEO: Giovanni Caforio) (“BMS”), and Nitto received the notification that BMS has decided not to exercise the option rights to further in-license ND-L02-s0201 for pulmonary fibrosis.
ND-L02-s0201 is siRNA oligonucleotide drug designed to inhibit HSP47 (Heat Shock Protein 47), a collagen specific chaperone which regulates collagen synthesis and secretion and causes fibrosis. In 2016, BMS and Nitto have entered into an agreement granting BMS exclusive worldwide rights for the development and commercialization of ND-L02-s0201 for the treatment of advanced liver fibrosis. The agreement also provided BMS with an option to receive exclusive rights to ND-L02-s0201 for the treatment of idiopathic pulmonary fibrosis.

The development of ND-L02-s0201 for the treatment of liver fibrosis and cirrhosis had been continued by BMS. However, Nitto received the notification from BMS that it was decided to discontinue the ongoing Phase 2 clinical trial of ND-L02-s0201 for the treatment of non-alcoholic steatohepatitis (NASH).

*1 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.

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