Bristol-Myers to develop Nitto's investigational anti-fibrosis drug

Bristol-Myers Squibb and Japan’s Nitto Denko Corporation (Nitto) have entered into an agreement granting Bristol-Myers Squibb exclusive worldwide rights for the development and commercialization of Nitto’s investigational siRNA molecules targeting heat shock protein 47 (HSP47) in vitamin A containing formulations.

The agreement includes Nitto’s lead asset ND-L02-s0201, currently in Phase 1b study for the treatment of advanced liver fibrosis. The agreement also grants Bristol-Myers Squibb the option to receive exclusive licenses for HSP47 siRNAs in vitamin A containing formulations for the treatment of lung fibrosis and other organ fibrosis. The agreement is subject to clearance under the Hart-Scott-Rodino Antitrust Improvements Act.

“Addressing the significant unmet need in fibrotic diseases is a key part of Bristol-Myers Squibb’s strategy to build a sustainable and diversified portfolio of transformational medicines,” said Francis Cuss, MB BChir, FRCP, executive vice president and chief scientific officer of Bristol-Myers Squibb. “We continue to invest in innovative approaches both internally and externally that may halt or slow the progression of fibrotic diseases and are pleased to partner with Nitto Denko to advance the development of therapies for patients living with advanced NASH and cirrhosis due to NASH who currently have limited treatment options.”

Hideo Takasaki, chief executive officer, Nitto Denko Corporation, said: “We believe our investigational anti-fibrosis drug has the potential to make a significant contribution to help patients with advanced liver fibrosis. We are very excited that Bristol-Myers Squibb joins our effort, as this will provide an accelerated development for this compound.

“From now on, Nitto group will support Bristol-Myers Squibb for further development and will continue our efforts to develop other organ fibrosis treatments including Idiopathic Pulmonary Fibrosis (IPF) through our newly established Nitto BioPharma Inc.”

Nitto’s lead product, ND-L02-s0201, is a targeted siRNA therapy that is designed to inhibit HSP47, a collagen specific chaperone which regulates collagen synthesis and secretion, and prevent further collagen deposition as well as enable resolution of existing fibrosis. Nitto is currently conducting a 5-week open-label Phase 1b study in patients with advanced fibrosis (F3-F4c) due to NASH or hepatitis C. The U.S. Food and Drug Administration granted fast track designation to ND-L02-s0201 for two indications, liver fibrosis and cirrhosis secondary to NASH and liver fibrosis and cirrhosis secondary to HCV.

Bristol-Myers pays $100M upfront

Under the terms of the agreement, Bristol-Myers Squibb will make an upfront payment of $100 million to Nitto. Bristol-Myers Squibb will be responsible for the development, manufacture, and commercialization of HSP47 siRNAs in vitamin A containing formulations for all liver diseases. Nitto is also eligible to receive subsequent clinical and regulatory milestone payments, royalties, sales based milestone payments as well as option exercise payments for lung and other organ fibrosis.