dgbio
Sep 28, 6:52 PM
$MIRM Mirum (brelo) vs Vir data (tove + eleb combo). Importantly, Mirum placed no limits on the baseline ALT levels and had 17-20% percent of patients with ALT>5x ULN vs 0% in Vir’s trial.
• At 24 weeks, Mirum’s P3 vs Vir’s P2
✓Combined response (Virologic + ALT), registrational endpoint:
56% (weekly dosing), 45% (monthly dosing) vs 47%
✓Virologic response:
86% (weekly dosing), 85% (monthly dosing) vs 100%
✓Safety, flu-like symptoms:
5% (weekly dosing), 11% (weekly dosing) vs 66%
• At 48 weeks, Mirum’s P2 vs Vir’s P2
✓Combined response (Virologic + ALT), registrational endpoint:
55% (weekly dosing), 55% (monthly dosing) vs 56%
✓Virologic response:
95% (weekly dosing), 95% (monthly dosing) vs 97%
• Mirum so far has
→ Same or better efficacy on the registrational endpoint despite about 20% severe patients in the trial.
→ Comparable efficacy on virologic response considering inclusion of severe patients.
→ Much better safety
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