BioSpace· Heather McKenzie·· 4 hours agoPickScore81
Disc’s rebuffed rare blood disease drug sets up FDA re-do after ‘clean’ Phase 3 sweep
In brief
Disc Medicine announced that bitopertin met all primary endpoints in the Phase 3 APOLLO trial in EPP (N=183): PPIX fell 41.4% versus placebo (p<0.0001), and sunlight tolerance time at month six increased by 12.2 hours (p=0.0010). All secondary endpoints were also positive.
Why it matters
The brief gives both primary endpoint figures, letting readers weigh them against the FDA's earlier doubts about the surrogate endpoint.
Source: BioSpace