Please login to the form below

Not currently logged in

BMS claims a win in mid-stage NASH trial

Its new liver disease therapy reduces fatty deposits and improves blood lipid profiles

BMSBristol-Myers Squibb has reported positive phase II results for its drug for non-alcoholic steatohepatitis (NASH), which is shaping up to be a major battleground for the pharma industry.

NASH - a progressive form of liver disease characterised by the accumulation of fatty deposits and fibrosis (scarring) - is predicted to overtake viral hepatitis and alcoholism as the leading cause of liver transplants by 2020, and affects millions of people around the world causing cirrhosis and liver cancer in some patients.

With no approved therapies, pharma companies are developing dozens of drugs to try to tap into what some analysts predict could progress into a $35bn market in the coming years, and there has been a deal frenzy with bigger companies napping up promising assets from smaller players.

Now BMS' ambitions in this endeavour have been boosted by a positive phase II trial for BMS-986036, a pegylated (long-acting) formulation of human fibroblast growth factor 21 (FGF21) in patients with NASH.

16-week data from the 74-patient study reported at the International Liver Congress (ILC) in Amsterdam, show that BMS' drug was able to achieve a significant reduction in liver fat compared to placebo, and there were also improvements in serum biomarkers for liver fibrosis and injury, as well as liver stiffness which is another surrogate marker for scarring.

For good measure the drug treatment also seemed to improved patients' blood lipid profiles, with triglycerides, low density lipoprotein (LDL) and high density lipoprotein (HDL) cholesterol all shifting in the desired direction.

Previously, BMS reported phase II data for BMS-986036 in diabetic patients, and with two positive trials in hand the company says it is "looking forward to sharing these data with health authorities to determine next steps for further study of this asset".

Other companies reported positive results from NASH trials at the ILC meeting, including Merck & Co-backed NGM Bio which reported phase II data on FGF19 candidate NGM282, and Gilead Sciences which presented the first clinical data on ACC inhibitor GS-0976.

These earlier-phase candidates are chasing drugs in the latter stages of development including Gilead's ASK1 inhibitor selonsertib, Allergan's recently-acquired CCR2/CCR5 inhibitor cenicriviroc, Genfit's PPAR agonist elafibranor and Intercept's Ocaliva (obeticholic acid), which is already on the market for another indication (primary biliary cholangitis).

Article by
Phil Taylor

24th April 2017

From: Research



Subscribe to our email news alerts

Featured jobs


Add my company
Onyx Health

Onyx Health is a healthcare communications and PR agency based in the North East of England, but with a national...

Latest intelligence

World Cancer Day 2023 – closing the gaps in cancer care to give more patients access to life-changing medicines
Great Expectations – exploring the counterpoint between advances in oncology and the challenges of ensuring life-changing medicines reach patients...
Strategic behaviour
Strong strategising depends on your colleagues’ behaviour...
Pharmaceutical Marketing Strategies For The Digital Age
In the digital age, a strong digital marketing strategy is crucial for businesses, especially in the highly competitive and complex pharmaceutical industry. There are key trends shaping pharmaceutical marketing, such...