other material
confidence high
sentiment positive
materiality 0.70
Phathom announces positive Ph3 NERD-301 topline results for vonoprazan; both doses met primary endpoint
Phathom Pharmaceuticals, Inc.
- Vonoprazan 10 mg and 20 mg both achieved significantly greater 24-hour heartburn-free days vs placebo (46.4% and 46.0% vs 27.5%; p<0.0001).
- Median percentage of heartburn-free days: 48.3% (10 mg), 46.7% (20 mg), 17.0% (placebo).
- Safety profile comparable to placebo; most common AE was nausea (2.3% 10 mg, 3.1% 20 mg, 0.4% placebo).
- Blinded 20-week long-term extension ongoing; full results expected later in 2023.
- Discussions with FDA ongoing regarding separate Phase 3 trial for on-demand dosing in NERD.