NorthSea pivots to diabetic NASH patients on Phase IIb icosabutate data

NorthSea’s engineered fatty acid missed the primary endpoint in the Phase IIb ICONA study to treat non-alcoholic steatohepatitis, but the Dutch biotech believes it has a path into Phase III based on a retrospective subgroup analysis of data in diabetic NASH patients.

In a late-breaking abstract released on Friday that’s to be presented at the annual American Association for the Study of Liver Diseases (AASLD) meeting, NorthSea Therapeutics B.V. said data from the 178-patient Phase IIb ICONA trial of icosabutate missed the primary endpoint of NASH resolution without worsening of fibrosis at both the 300 mg and 600 mg doses vs. placebo. Both doses also missed the secondary endpoint of at least one stage of fibrosis improvement without worsening of NASH in the overall population — which would be a co-primary endpoint in a Phase III study. ...