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Disc Medicine reports bitopertin met all Phase 3 APOLLO endpoints, reducing PPIX by 41.4%
IRONDisc Medicine, Inc.
Disc Medicine announced positive topline results from the pivotal Phase 3 APOLLO trial of bitopertin in adults and adolescents with erythropoietic protoporphyria (EPP) and X-linked protoporphyria (XLP). The study enrolled 183 patients and met all primary and secondary endpoints. Bitopertin achieved a statistically significant reduction in whole-blood metal-free protoporphyrin IX of 41.4% versus placebo and increased average monthly total time in light without pain by 12.2 hours during month 6. The drug also significantly reduced the incidence rate of phototoxic reactions and improved patient-reported quality-of-life scores. Bitopertin was generally well-tolerated with no new safety signals. Based on these results, Disc plans to resubmit a New Drug Application to the FDA by the end of 2026, with an agency decision anticipated by mid-2027. Disc Medicine is a clinical-stage biopharmaceutical company focused on discovering and developing novel treatments for serious hematologic diseases.