Drug Development

EASL Roundup: Bristol-Myers and NGM post a positive look at PhII NASH data; Genfit details PhIII delay

Over the weekend some of the prospective players in the NASH field had a chance to roll out new data on their contenders for the field at the annual EASL meeting. We were treated to some intriguing early- and mid-stage data on liver fat levels that could be important further down the R&D road. And a top late-stage player spotlighted a delay that could set it behind rivals in the field.

Bill Berkrot at Reuters did a great deep dive on NASH, a big market disease that could be worth tens of billions of dollars every year. NASH and fatty liver disease are the hallmark of an increasingly obese, sedentary global population. Ultimately, the disease could lead to liver transplants, though there is a lot left to be learned about disease progression and risk.

The top companies in the field now include Gilead and Allergan with Novartis, Merck, Bristol-Myers and J&J all angling in. France’s Genfit is also a key player.

Here’s a look at the top headlines from EASL in Amsterdam:

Bristol-Myers drug flushes liver fat in Phase II

Bristol-Myers Squibb led the group over the weekend with its Phase II data out on BMS-986036, human fibroblast growth factor 21. Both 10 mg and 20 mg weekly doses knocked down liver fat by 6.8% and 5.2% compared to only 1.3% in the placebo arm. And they tracked the changes through imaging technology.

Bristol-Myers has been working on biomarkers that can also track the impact of a drug, looking for ways to get around the liver biopsies — expensive and demanding on patients — that have been used for definitive insight.

“We are encouraged by the improvements these data showed across multiple aspects of NASH, and that patients could be effectively evaluated through imaging rather than through invasive liver biopsy,” said Mike Burgess, head of Cardiovascular, Fibrosis and Immunoscience Development, Bristol-Myers Squibb.

NGM Bio Phase II hits primary NASH endpoint

Stephen Harrison

NGM Bio turned out in Amsterdam to boast about the impact of NGM282 in another Phase II trial. Investigators said that they tested 3 and 6 mg subcutaneous doses over 12 weeks in 82 NASH patients with early-stage fibrosis. They came up with 9.7% and 11.9% reductions in liver fat.

About a third of the patients hit a normal level of liver fat, while 4 out of 5 achieved the primary endpoint in fat reduction. Researchers also saw some improvements in biomarkers of liver function, lipid metabolism and fibrosis, though this drug would have a far way to go to nail down solid efficacy data.

“NGM282 is the first agent I’ve tested that holds the potential to completely reverse steatosis in as short as 12 weeks of therapy,” said Stephen Harrison, Medical Director at Pinnacle Clinical Research and Visiting Professor of Hepatology at the Radcliffe Department of Medicine at University of Oxford, UK.

NGM struck a big $450 million deal with Merck in 2015 that is helping pay the bills while it advances its own pipeline.

Genfit explains a significant delay for PhIII NASH study

Paris-based Genfit has run into some hurdles in recruiting patients for its closely watched RESOLVE-IT Phase III, which will delay its timeline by up to six months. The biotech says that the delay is partly due to the challenge of recruiting patients at a time experimental drugs in the clinic are proliferating. But it says the big obstacle is its own “desire to ensure enrollment quality so as to produce the most statistically robust clinical trial by ensuring that patient stratification ratios remain as close as possible to the medical reality.”

Genfit outlined the slowdown in its Q1 update.


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