Novartis reveals strong Phase 2b data for tropifexor in non-alcoholic steatohepatitis

pharmafile | November 11, 2019 | News story | Research and Development, Sales and Marketing Novartis, nash, non-alcoholic steatohepatitis, pharma 

The latest findings have been revealed from the final stage of Novartis’ Phase 2b evaluation of its non-bile acid FXR agonist tropifexor in the treatment of biopsy-confirmed stage 2-3 fibrotic non-alcoholic steatohepatitis (NASH).

Data from an interim analysis of the study revealed that the upper doses of the drug – 140 Mu g and 200 Mu g specifically – were proven to “significantly improve” a raft of biomarkers for the condition, including body weight, hepatic fat fraction, and alanine aminotransferase.

The candidate’s safety profile was also said to be “favourable” after 12 weeks of treatment.

“NASH is a complex disease with currently no approved pharmacological treatments,” said Eric Hughes, Global Development Unit Head, Immunology, Hepatology and Dermatology. “We are encouraged by the results tropifexor has shown in monotherapy while we continue to investigate its potential as a backbone therapy in combination treatments for NASH.”

The company confirmed that these findings will be presented at The Liver Meeting 2019, while full 48-week biopsy data is expected to be released in the second quarter of 2020.

Matt Fellows

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