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Gilead Hit With Another NASH Setback As Selonsertib Fails In First Phase III

 
• By Joseph Haas

Primary endpoint miss for Phase III selonsertib in cirrhotic NASH patients follows disappointing data at both 2018 major liver conferences. STELLAR-3 in NASH patients with bridging fibrosis looms large for Gilead’s hopes.

Down arrow on pavement

Gilead Sciences Inc. revealed shortly after the stock market closed on Feb. 11 that its most advanced non-alcoholic steatohepatitis (NASH) candidate, selonsertib, missed the primary endpoint in STELLAR-4, the first of two pivotal Phase III trials under way for the apoptosis-signaling kinase-1 (ASK1) inhibitor.

Gilead now must place significant hopes on the Phase III STELLAR-3 study, expected to report initial data during the second quarter of 2019 in NASH patients with bridging fibrosis

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