In NASH, Gilead Swung For The Fences And Struck Out Again

Gilead took a risky approach with selonsertib in NASH, pursuing a tough liver fibrosis benefit and failing, continuing a trend of disappointments outside of its antiviral franchises. Analysts don’t expect the second Phase III study in less-sick patients to succeed either.

Arrows miss target

The non-alcoholic steatohepatitis (NASH) drug-development race poses many variables, including which endpoint to pursue in pivotal studies. Gilead Sciences Inc. confirmed how challenging this can be by choosing to demonstrate a fibrosis benefit in very sick patients with its candidate selonsertib, which failed by this measure in a Phase III clinical trial.

What this means for the company's future chances in NASH and for other firms in the space remains unclear, but optimism for other approaches may have waned based on data from selonsertib in STELLAR-4 – the first Phase III study with results in NASH patients

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