November 10, 2016
By Alex Keown, BioSpace.com Breaking News Staff
NEW YORK – Competition is getting tighter in the market to treat non-alcoholic steatohepatitis (NASH). This morning Bristol-Myers Squibb struck a $100 million deal with Osaka, Japan-based Nitto Denko Corporation for rights to that company’s Phase Ib therapy.
The deal allowed Bristol-Myers Squibb to deepen its commitment to the liver fibrosis market with Nitto’s lead asset. The asset, ND-L02-s0201, is aimed at the treatment of liver fibrosis. It 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 five-week open-label Phase 1b study in patients with advanced fibrosis (F3-F4c) due to NASH or hepatitis C, the companies said this morning in a joint statement. 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.
Additionally, the agreement 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.
“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, 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.”
NASH is a progressive form of fatty-liver disease that has been directly associated with diabetes and obesity. Excessive accumulation of fat in the liver induces chronic inflammation, which causes progressive fibrosis, cirrhosis and eventually end-stage liver disease. The prevalence of NASH is increasing worldwide in part due to the increase of obesity and diabetes diagnoses. According to the National Institute of Diabetes and Digestive and Kidney Diseases, NASH affects 2 to 5 percent of people in the U.S. There are currently no specific treatments aside from weight loss, increased physical activity, and avoiding alcohol and unnecessary medications. NASH is projected to become the leading indication for liver transplant by 2020.
Last year BMS acquired Lexington, Mass.-based Promedior, Inc. and its lead product to enhance the company’s early-stage fibrosis portfolio. That portfolio included lead drug PRM-151, is a recombinant form of human pentraxin-2 protein currently in Phase II development for the treatment of idiopathic pulmonary fibrosis (IPF) and myelofibrosis (MF).
The NASH market is expected to reach $40 billion by 2025, according to analyst predictions. BMS is not the only company entering the fray to acquire companies focused on therapies for this issue. Allergan has been snapping up multiple companies focused on NASH treatments this year, including Akarna Therapeutics, Ltd. and Tobira Therapeutics. Brent Saunders, Allergan’s president and chief executive officer, said NASH will become a chronic disease of epidemic proportions. Because of that, the company is investing heavily in new treatments. Gilead Sciences is also taking aim at other liver diseases beyond hepatitis C. Earlier this year, Gilead Sciences snapped up Cambridge, Mass.-based Nimbus Apollo, Inc. for its Acetyl-CoA Carboxylase (ACC) inhibitor program in an effort to bolster the company’s pipeline for metabolic disorders and the treatment of non-alcoholic steatohepatitis (NASH). The addition of NDI-010976 will back up NASH research Gilead is conducting with its investigational monoclonal antibody simtuzumab, which was acquired from Arresto Biosciences in 2011. In total, Gilead has five candidates, including standalone and combination, therapies for NASH in its pipeline. In 2015, San Diego-based startup Metacrine, Inc. launched with goals of developing treatments for NASH and other liver disorders. Although the company has remained tight-lipped about its approaches, its therapies are armed with a therapy acquired from the Salk Institute.
