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Press Release 2023

2023/Sep/15

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) (hereafter"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 safety and tolerability were demonstrated. These results were shared and discussed with Bristol Myers Squibb Company (Headquarters: New York City, New York, USA; CEO: Giovanni Caforio) (hereafter"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 synthesis and secretion of collagen that 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.

BMS continues to develop ND-L02-s0201 for the treatment of liver fibrosis and cirrhosis. 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 unknown cause in which collagen accumulation and thickening of the tissue surrounding the lung’s air sacs (interstitium) occurs as a result of repeated alveolar injury and repair. IPF, associated with poor prognosis, is designated as one of the intractable diseases in Japan.

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