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Tobira Says Secondary Endpoint In NASH Will Carry CVC Into Pivotal Study

 
• By Joseph Haas

The biotech argues that success in reducing fibrosis is more important than the failed primary endpoint measuring NAFLD activity score improvement – and also meets FDA's expectations – but the firm is taking a beating nonetheless.

Tobira Therapeutics Inc.'s CENTAUR trial may have failed on the primary endpoint, but the firm argues that the success on a key secondary endpoint of its Phase IIb study of cenicriviroc in NASH fits FDA's expressed standards for approval.

On July 25, Tobira announced that cenicriviroc (CVC), its dual CCR2/CCR5 inhibitor, missed the primary endpoint of improvement in the non-alcoholic fatty liver disease (NAFLD) activity in the Phase IIb CENTAUR trial, but noted the study did demonstrate a clinically and statistically significant improvement in fibrosis of at least one stage without worsening of non-alcoholic steatohepatitis (NASH) after

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