Disc Medicine gets FDA alignment on Phase 3 plan for bitopertin in EPP; accelerated approval possible

Disc Medicine, Inc.

FDA agreed on all APOLLO trial parameters: single placebo-controlled study, 60 mg dose, 6-month duration, primary endpoint of monthly sunlight time without pain.
Potential for accelerated approval using PPIX reduction as surrogate endpoint, allowing NDA submission based on existing data.
APOLLO trial to include EPP and XLP patients aged 12+; initiation planned by mid-2025.
Company to meet FDA to finalize details; update on NDA timing expected Q1 2025.
Positive FDA feedback provides clear registration path for bitopertin in erythropoietic protoporphyria.

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