Disc’s rebuffed rare disease drug sets up FDA redo after ‘clean’ Phase 3 sweep

Disc Medicine's bitopertin met all primary and secondary endpoints in the Phase 3 APOLLO trial. In 183 patients with erythropoietic protoporphyria (EPP), blood PPIX fell 41.4% versus placebo (p<0.0001), and sunlight exposure at month six increased by 12.2 hours (p=0.0010). The company plans to resubmit its FDA application.