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Posted On: 09/26/2024 6:05:26 PM
Post# of 148862
Pegozafermin received BTD for MASH due to these phase 2b results.
At 24 weeks, the percentage of patients with an improvement in fibrosis of at least one stage without worsening of NASH was significantly higher with pegozafermin than with placebo at both the weekly 30-mg dose (26% vs. 7%; difference, 19 percentage points, 95% confidence interval [CI], 5 to 32; P=0.009) and the every-2-week 44-mg dose (27% vs. 7%; difference, 20 percentage points; 95% CI, 5 to 35; P=0.008)
The percentage of patients with NASH resolution without worsening of fibrosis also favored pegozafermin over placebo in both the 30-mg pegozafermin group (23% vs. 2%; difference, 21 percentage points; 95% CI, 9 to 33) and the 44-mg pegozafermin group (26% vs. 2%; difference, 24 percentage points; 95% CI, 10 to 37)
The trial included 14 biopsy confirmed NASH patients with compensated cirrhosis (F4 patients) who were not part of the primary analysis, but continued in the study, 12 of which underwent a follow-up biopsy at Week 24. Five out of eleven of these patients treated with pegozafermin had fibrosis improvement ≥1 stage without worsening of NASH.
https://www.nejm.org/doi/full/10.1056/NEJMoa2304286
They've recently started a phase 3 trial for F2-F3 and a separate trial for F4 patients.
At 24 weeks, the percentage of patients with an improvement in fibrosis of at least one stage without worsening of NASH was significantly higher with pegozafermin than with placebo at both the weekly 30-mg dose (26% vs. 7%; difference, 19 percentage points, 95% confidence interval [CI], 5 to 32; P=0.009) and the every-2-week 44-mg dose (27% vs. 7%; difference, 20 percentage points; 95% CI, 5 to 35; P=0.008)
The percentage of patients with NASH resolution without worsening of fibrosis also favored pegozafermin over placebo in both the 30-mg pegozafermin group (23% vs. 2%; difference, 21 percentage points; 95% CI, 9 to 33) and the 44-mg pegozafermin group (26% vs. 2%; difference, 24 percentage points; 95% CI, 10 to 37)
The trial included 14 biopsy confirmed NASH patients with compensated cirrhosis (F4 patients) who were not part of the primary analysis, but continued in the study, 12 of which underwent a follow-up biopsy at Week 24. Five out of eleven of these patients treated with pegozafermin had fibrosis improvement ≥1 stage without worsening of NASH.
https://www.nejm.org/doi/full/10.1056/NEJMoa2304286
They've recently started a phase 3 trial for F2-F3 and a separate trial for F4 patients.
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