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Science Matters: Merck Joins Crowded NASH Race As Several Data Readouts Loom

 
• By Mark Ratner

No NASH treatments are on the market yet, but Phase III data readouts are emerging, mid-stage drugs are demonstrating their capabilities and combinations are in view. 

Although no drug has been approved to treat non-alcoholic steatohepatitis (NASH), the clinical drug development landscape around the disease is maturing rapidly. Gilead Sciences Inc. and Intercept Pharmaceuticals Inc. are awaiting further readouts from Phase III NASH trials in the first half of 2019. Compounds in mid-stage trials have now demonstrated an ability to impact the disease in a short amount of time, and regulators have provided clarity around acceptable surrogate endpoints for early trials, which helps make trial design more efficient. As a result, companies are expanding their portfolios, contemplating combination drug strategies and eying new targets.

The field became more crowded in January, when Merck & Co. Inc. teed up its first clinical candidate, a...

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