Disc Medicine, Inc. — Form 8-K

Disc Medicine announced that bitopertin successfully met both co-primary endpoints and all secondary endpoints in the APOLLO Phase 3 trial of 183 patients with erythropoietic protoporphyria (EPP) or X-linked protoporphyria (XLP). Key results: 41.4% reduction in protoporphyrin IX (PPIX) versus placebo (p<0.0001), 12.2-hour increase in average monthly time in light without pain during month 6 versus placebo (p=0.0010), 71% reduction in phototoxic reaction incidence rate versus placebo (p<0.0001), and statistically significant improvements in quality-of-life measures (PGIC and PGIS, p<0.0001). Bitopertin was well-tolerated with dizziness (50% of treated patients, mild-to-moderate and transient) as the most common adverse event; no new safety signals observed. Disc plans to resubmit an NDA to the FDA by end of 2026, with an FDA decision anticipated by mid-2027.