NASH's dynamic development race has no shoo-in leader of hefty market given multiple disease targets – experts

06 May 2016

The drug development race in nonalcoholic steatohepatitis’ (NASH) has no clear frontrunner as future standard of care (SOC), given varying mechanisms tackling a disease with multiple targets, experts said. Treatments aiming at reducing liver fat and inflammation could face the most scepticism due to the need of stronger evidence linking these mechanisms with fibrosis treatment needed in NASH, they added. NASH is a big drug development opportunity given the disease’s increasing social and economic burden and lack of approved therapies, they noted.

The drug development race in nonalcoholic steatohepatitis’ (NASH) has no clear frontrunner as future standard of care (SOC), given varying mechanisms tackling a disease with multiple targets, experts said. Treatments aiming at reducing liver fat and inflammation could face the most scepticism due to the need of stronger evidence linking these mechanisms with fibrosis treatment needed in NASH, they added.

NASH is a big drug development opportunity given the disease’s increasing social and economic burden and lack of approved therapies, they noted.

The two most advanced NASH treatments in development are Intercept Pharmaceuticals’ (NASDAQ:ICPT) Ocaliva (obeticholic acid) and Genfit’s (EPA:GNFT) GFT-505 (elafibranor), both having started their Phase III trials in the past eight months and are expected to reach the market in 2019. The peak sales estimate for Ocaliva for NASH is USD 3.5bn.

Other companies further down in the development line include Galmed Pharmaceuticals’ (NASDAQ:GLMD) aramchol, Tobira Therapeutics’ (NASDAQ: TBRA) cenicriviroc mesylate (CVC) both in Phase IIb, San Francisco-based NGM Biopharmaceuticals’ Phase II NGM282 and Galectin Therapeutics’ (NASDAQ:GALT) Phase II GR-MD-02.

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