Gilead Sciences, Inc. GILD and Denmark-based pharma giant Novo Nordisk A/S NVO announced that both the companies intend to collaborate for developing treatments for non-alcoholic steatohepatitis (NASH).
The companies will initiate a proof-of-concept study combining Novo Nordisk's semaglutide (GLP-1 analogue) and Gilead's cilofexor (FXR agonist) and firsocostat (ACC inhibitor) for the treatment of patients with NASH.
The collaboration comes at a time when Gilead is trying desperately to develop a NASH pipeline.
NASH, a chronic liver disease, is caused by excessive fat accumulation in the liver or steatosis. Per records, the disease has affected up to 15 million people in the United States, and could cause inflammation, hepatocellular injury, progressive fibrosis and cirrhosis. The ailment is anticipated to become the leading reason behind liver transplantation by 2020.
Currently, NASH is the primary reason for liver transplants in people aged below 50 years in the United States. Such patients also suffer from obesity and type II diabetes. With no treatments currently approved to address this disease, the market opportunity is substantially huge and many companies are investing a major chunk of their R&D budget on the same.
Gilead had suffered a setback with the failure of a late-stage study on pipeline candidate, selonsertib, in patients with compensated cirrhosis (F4) due to NASH. Given the persistent decline in HCV sales, the company is looking to HIV and newer avenues to boost its top line. The company is intending to foray into the NASH and inflammation markets with late-stage candidates, selonsertib and filgotinib, respectively.
The stock has gained 5.2% in the year so far, lagging the industry's growth of 8.8%.
Gilead is expecting that a cocktail therapy of its NASH compounds with Novo Nordisk's semaglutide might work for it.
Ozempic, the injectable formulation of semaglutide, is a diabetes medicine, used with diet and exercise to treat adults whose type II diabetes is not satisfactorily controlled.
Since the NASH patients mostly suffer from obesity and diabetes, both the companies expect the combination therapy to yield positive results.
However, competition is stiff in the NASH space. The winner so far in the NASH race seems to be Intercept Pharmaceuticals, Inc ICPT. The company recently announced positive top-line results from its pivotal phase III REGENERATE study of obeticholic acid (OCA) in patients with liver fibrosis due to NASH. The company stated that the primary endpoint of the study — fibrosis improvement without worsening of NASH at 18 months — was achieved with the 25 mg daily dose of OCA.
France-based, Genfit’s GNFT lead candidate elafibranor, which is in late-stage studies for NASH, also holds promise.
Gilead currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
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