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Disc Medicine Reports Successful Phase 3 Bitopertin Trial Results

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IRON$56.84 0.34%

Disc Medicine, Inc. (IRON) announced positive topline results from its Phase 3 APOLLO clinical trial evaluating bitopertin. The study met all primary and secondary endpoints, demonstrating a 41.4% reduction in whole-blood metal-free protoporphyrin IX (PPIX) compared to placebo. Patients receiving bitopertin gained an average of 12.2 additional hours of monthly pain-free light exposure at six months.

The trial also highlighted broad treatment benefits, including a 71% decrease in phototoxic reactions and improvements in overall patient quality-of-life measures. Bitopertin was generally well-tolerated during the study, with mild to moderate dizziness reported as the most common side effect in half of the participants.

Following these late-stage trial results, Disc Medicine plans to resubmit a New Drug Application to the U.S. Food and Drug Administration by the end of 2026. A regulatory decision from the agency is expected by mid-2027.

Key points

  • Bitopertin met all primary and secondary endpoints in Disc Medicine's Phase 3 APOLLO trial.
  • Patients gained an average of 12.2 hours of pain-free light exposure per month at six months.
  • Treatment reduced whole-blood metal-free PPIX levels by 41.4% relative to placebo.
  • Phototoxic reactions decreased by 71%, with mild to moderate dizziness as the primary side effect.
  • Disc Medicine aims to resubmit its NDA to the FDA by late 2026, expecting a decision by mid-2027.

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Questions and answers

What were the Phase 3 APOLLO trial results for Disc Medicine's bitopertin?

The Phase 3 trial met all primary and secondary endpoints. Bitopertin reduced PPIX levels by 41.4% versus placebo and increased monthly pain-free light time by an average of 12.2 hours at six months.

What side effects were reported in the bitopertin trial?

Bitopertin was generally well-tolerated. The most common side effect was mild to moderate dizziness, which occurred in 50% of trial participants.

When does Disc Medicine expect FDA approval for bitopertin?

Disc Medicine plans to resubmit its New Drug Application to the FDA by the end of 2026 and anticipates a regulatory decision by mid-2027.