Cirius’ Mixed Phase IIb Results In NASH Don’t Quell Its Enthusiasm For Phase III
Privately held biotech plans to move insulin sensitizer into Phase III with ambitious goals of obtaining accelerated approval based on liver histology, while also trying to show long-term cardiovascular benefits.
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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.
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.
NGM’s injectable might be best-suited as induction therapy for sicker NASH patients, Inventiva hopes its pan-PPAR agonist will outperform Genfit’s elafibranor, and Albireo thinks IBAT inhibition offers promise in NASH.