Cirius Suspects Insulin Resistance Is Underlying Key To NASH
The former Octeta is expanding the ongoing Phase IIb study of its second-generation insulin sensitizer. An insulin sensitizer with a better safety profile than first-generation drugs like Actos may provide a backbone therapy for NASH, the company believes.
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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.
Phase IIb interim look shows liver enzyme reductions, signs of glycemic control and no increase in peripheral edema from baseline. Cirius expects to have final data in the second half of 2019.
Privately held Cirius and NGM and big pharma Bristol-Myers Squibb are in Phase II for NASH with programs also working to validate non-invasive biomarkers for diagnosis, prognosis and treatment impact.