Pfizer is joining forces with Novartis with a throw it all at the wall and see what sticks approach as they look to combine NASH assets to see if it can beat out liver fat, and get a slice of a potentially multi-billion future market.
We all know the drill by now: NASH, a form of non-alcoholic fatty liver disease, is set to become the biggest factor in liver transplants in the next 30 years, and is increasing along with growing rates of obesity and diabetes.
If left untreated, NASH can cause damage and scarring to the liver and eventually may cause it to fail. It has a global prevalence of around 3%.
Some analysts have seen this market as a $35 billion opportunity at peak, though others see it much lower; currently, tests for the condition can be highly invasive, and having a fatty liver does not always mean it will go on to cause scarring or end-stage liver disease.
Even though it is associated with obesity, it can also affect leaner people, adding to complications in assessing those who may be at risk.
Diet and exercise can help lower liver fat, but there are as yet no drugs for the condition. Still, it seems nearly every biopharma in the world is developing a drug or drugs with hopes it can hit liver fat and reduce the risk of liver damage.
RELATED: Intercept's much-hyped NASH drug misses the mark in Phase II
There are a host of different MOAs being experimented with to help with this: Pfizer and Novartis are now seeing if combos of their meds can boost efficacy.
The U.S. Big Pharma’s non-exclusive clinical pact with Novartis is set to have the pair work preclinical and early-stage clinical test with of Pfizer’s investigational therapies, including an Acetyl CoA-Carboxylase (ACC) Inhibitor (PF-05221304, currently in phase 2), a Diacylglycerol O-Acyltransferase 2 (DGAT2) Inhibitor (PF-06865571, phase 1) and a Ketohexokinase (KHK) Inhibitor (PF-06835919, phase 2).
This will be used together with Novartis’s tropifexor, a non-bile acid, Farnesoid X receptor (FXR) agonist.
And that’s all she wrote on details, but the pair will hope to have better luck than some of its later-stage rivals, who have come up against issues in testing. This includes Shire, which in the summer abruptly stopped a midstage test of its NASH candidate volixibat, with setbacks and trial rejigs also hitting GenFit and Intercept in the last few years.