Quote:"Fibrosis improvement by at least one stage with no worsening of the NAFLD activity score was achieved in 24.2% of the patients in the 80-mg resmetirom group and 25.9% of those in the 100-mg resmetirom group, as compared with 14.2% of those in the placebo group (P<0.001 for both comparisons with placebo).
With 11.7% of patients showing benefit vs. placebo that's not spectacular. with a p value of .001 I figured that had to be a decent amount of patients and it was, 966 patients in total. If they had the 72 patients we had in our phase 2 they almost certainly wouldn't have hit statistical significance.
The end points between their trial and ours were different mainly because ours was phase 2, theirs was phase 3. But even with 72 patients we achieved statistical significance in fibrosis in 350mg and pooled 350mg/700mg. With 700mg showing better response in the study than the 350mg (as it should) and a much larger trial with proper population distribution the results should handily beat Remesitrom.
Quote:cTI absolute change from baseline
Placebo: 27.64
Leronlimab 700 mg: -2.73 (P = 0.059 vs placebo, not significant)
Leronlimab 350 mg: -24.38 (P = 0.021 vs placebo)
Leronlimab 700 and 350 mg pooled: -13.39 (P = 0.013 vs placebo)https://www.natap.org/2022/EASL/EASL_70.htm
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