Intercept’s CRL Just Continues Upheaval In NASH
With approval timeline for OCA now thoroughly unclear and Genfit on the ropes, might the top spot in NASH end up with Galmed, AbbVie, Madrigal, Inventiva or Gilead instead?
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Metacrine halts development of its FXR agonist compounds in NASH and turn its focus to inflammatory bowel disease. Firm plans Phase II ulcerative colitis study in 2022 with MET642.
Biotech is determining which of its mid-stage FXR candidates – MET409 and MET642 – will offer the best overall profile to take into Phase IIb. It is also studying ‘409 in combination with Jardiance and will test the FXR class in inflammatory bowel disease.
Full-year findings for resmetirom reported at EASL confirm 16-week data in non-alcoholic steatohepatitis presented in 2020. Analysts say these data continue to de-risk the drug, but more important readouts await.