September 21, 2016
By Alex Keown, BioSpace.com Breaking News Staff
DUBLIN – In less than a day, Allergan has once again flexed its M&A muscle to bolster its liver disease pipeline by acquiring San Diego-based Akarna Therapeutics, Ltd. and its lead candidate to treat non-alcoholic steatohepatitis (NASH) and other liver diseases.
Allergan plopped down $50 million in upfront payments to acquire the privately-held company. Other milestone payments will be factored in, but what those are was not disclosed in Akarna’s announcement.
Akarna’s lead product is AKN-083, a small molecule, non-bile acid FXR agonist. FXR is a master regulator of carbohydrate and lipid metabolism, bile-acid homeostasis, inflammation and fibrosis, all of which are associated with the pathology and progression of NASH. AKN-083 has high affinity, potency and selectivity for FXR and has demonstrated robust in vivo proof of concept in animal models of steatosis and fibrosis.
Raju Mohan, chief executive officer of Akarna, said the company is excited to work with Allergan, which “shares our commitment to help patients with NASH live longer, healthier lives.”
The Akarna acquisition comes a day after Allergan announced it was acquiring San Francisco-based Tobira Therapeutics in a deal that could hit $1.695 billion. Tobira has two NASH programs, enicriviroc (CVC) and Evogliptin. CVC is a Phase III ready immunomodulator that acts by blocking two chemokine receptors, CCR2 and CCR5, both of which are indicted in inflammation and fibrogenic pathways in NASH. Evogliptin is an oral DPP-4 (Dipeptidyl peptidase-4) inhibitor currently being studied in a Phase I trial.
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.
Brent Saunders, Allergan’s president and chief executive officer, said NASH will become a chronic disease of epidemic proportions.
“With the increasing rates of diabetes, obesity and other metabolic conditions in the U.S. and in developed nations globally, NASH is set to become one of the next epidemic-level chronic diseases we face as a society. It is important that we invest in new treatments today so that healthcare systems, providers and patients have treatment options to face this challenge in the coming years,” Saunders said in a statement following the announcement of the company’s deal to acquire Tobira.
Allergan is not the only company to snap up entities working on NASH. 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. Gilead’s simtuzumab has had something of a troubled history, with the company ceasing several drug trials for various disorders.
