Disc Medicine aligns with FDA on bitopertin confirmatory trial design; NDA planned H2 2025

Disc Medicine, Inc.

Achieved FDA alignment on APOLLO post-marketing trial design for bitopertin in EPP and XLP.
Co-primary endpoints: monthly total sunlight time without pain and percent change in whole-blood PPIX.
Plans to submit NDA for accelerated approval in H2 2025 based on Phase 2 BEACON and AURORA data.
APOLLO trial to enroll ~150 patients aged 12+, randomized 1:1, 60 mg dose, double-blind placebo-controlled.
Trial initiation expected by mid-2025; enrollment underway by potential accelerated approval date.

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