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Cirius’ Mixed Phase IIb Results In NASH Don’t Quell Its Enthusiasm For Phase III

 
• By Joseph Haas

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.

Glycogen in liver and muscle. Insulin sensitive and Insulin resistant. - Vector
Cirius believes an insulin-sensitizer approach will succeed in NASH

Cirius Therapeutics Inc. obtained mixed results in the Phase IIb dose-ranging study of its insulin-sensitizer MSDC-0602K in non-alcoholic steatohepatitis (NASH), but the privately held firm thinks it can demonstrate statistical significance for a series of metabolic and liver histology endpoints in Phase III merely by adjusting the study design and powering it with more patients.

Given the spotty history of NASH development so far, including companies taking drugs forward into Phase III on the basis of modest efficacy or efficacy based on post-hoc data analysis in mid-stage studies, Cirius seems likely to be able to move forward with MSDC-0602K, a second-generation thiazolidinedione (TZD), which it hopes will demonstrate the benefits of drugs like Actos (pioglitazone) without the dose-limiting concerns of cardiovascular risk, edema, bone-density loss and bladder cancer risk

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