Bristol-Myers Squibb gains rights to potential liver fibrosis drug

Bristol-Myers Squibb announced it has entered an agreement with Nitto Denko Corporation that grants worldwide rights for the development and commercialization of Nitto’s investigational siRNA molecules targeting heat shock protein 47, including ND-L02-s0201, its lead investigational drug for the treatment of advanced liver fibrosis.

ND-L02-s0201 (Nitto Denkco) is a targeted siRNA therapy designed to inhibit heat shock protein 47 (HSP47) — a collagen synthesis and secretion — to disable further collagen deposition and enable resolution of existing fibrosis. Researchers are investigating the treatment in a 5-week open-label phase 1b study in patients with advanced fibrosis due to nonalcoholic steatohepatitis or hepatitis C virus, per a press release.

“We believe our investigational anti-fibrosis drug has the potential to make a significant contribution to help patients with advanced liver fibrosis,” Hideo Takasaki, chief executive officer, Nitto Denko Corporation, said in the release.

Under the agreement, Bristol-Myers Squibb will be responsible for the development, manufacturing and commercialization of HSP47 siRNAs in vitamin A containing formulations for all liver diseases. Bristol-Myers Squibb also will have the option to receive exclusive licenses for HSP47 siRNAs in vitamin A containing formulations for the treatment of lung fibrosis and other organ fibrosis. Nitto is eligible to receive subsequent clinical and regulatory milestone payments, royalties, sales-based milestone payments, and option exercise payments for lung and other organ fibrosis.

“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,” Francis Cuss, MB BChir, FRCP, executive vice president and chief scientific officer of Bristol-Myers Squibb, said in the release. “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.”

The FDA granted fast track designation to ND-L02-s0201 for both NASH and HCV liver fibrosis indications in October 2015, per Nitto.

Disclosures: Takasaki is employed by Nitto Denko Corporation. Cuss is employed by Bristol-Myers Squibb.