Madrigal Cements Case For Hepatic Fat Reduction, Other NASH Benefits With MGL-3196
Madrigal’s selective THR beta agonist continues to demonstrate hepatic fat-lowering abilities in 36-week data, along with lipid-lowering characteristics. The company hopes to initiate a Phase III study in early 2019.
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Execs from Madrigal, Cirius and Axcella say the FDA’s complete response letter is specific to shortcomings of Intercept’s OCA – and leaves the race to be first to market wide open again.
The US FDA complete response letter for Intercept’s obeticholic acid raised speculation that the agency might be rethinking approvable endpoints for NASH. But analysts generally think OCA’s unspectacular efficacy data is behind the decision.
A month after Genfit’s Phase III failure, Inventiva hits multiple endpoints in a Phase IIb study of pan-PPAR agonist lanifibranor – likely drawing partnering or acquisition interest. Ascletis offers Phase II evidence for its NASH drug.