other material
confidence high
sentiment neutral
materiality 0.70
Disc Medicine bitopertin Phase 2 in EPP meets primary endpoint; key secondary misses significance
Disc Medicine, Inc.
- Primary endpoint met: PPIX reduced 21.6% (20mg, p=0.003) and 40.7% (60mg, p<0.001) vs placebo +8.0%.
- Key secondary (cumulative sunlight time) not significant: 175.1h (20mg), 153.1h (60mg) vs 133.9h placebo due to strong placebo response.
- Phototoxic reactions with pain reduced 75% for 60mg (p=0.011) and 60% for 20mg (p=0.109).
- Patient Global Impression of Change: 86% of 60mg completers rated 'much better' vs 50% placebo (p=0.022).
- Bitopertin well tolerated, no SAEs; dizziness most common AE; two discontinuations at 60mg.