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Disc Medicine Announces Completion of Enrollment of Phase 3 APOLLO Trial of Bitopertin in Erythropoietic Protoporphyria
Last participant has been randomized and dosed in the Phase 3 APOLLO study of bitopertin in erythropoietic protoporphyria (EPP)The study size was expanded to
About this update from Disc Medicine, Inc.
[{"type":"text","content":"Last participant has been randomized and dosed in the Phase 3 APOLLO study of bitopertin in erythropoietic protoporphyria (EPP)The study size was expanded to 183 participants due to patient and physician demandResults of the APOLLO study are expected in Q4 2026 WATERTOWN, Mass., March 26, 2026 (GLOBE NEWSWIRE) -- Disc Medicine, Inc. (NASDAQ:IRON), a clinical-stage biopharmaceutical company focused on the discovery, development, and commercialization of novel treatments for patients suffering from serious hematologic diseases, today announced that the last participant has been randomized and dosed in the pivotal Phase 3 APOLLO trial of bitopertin in EPP. Originally planned as an N=150 study, the study was expanded to 183 participants due to patient and physician demand. “We are pleased to have completed enrollment in our APOLLO study in less than a year and we extend our gratitude to the EPP community for their continued contributions to the development of bitopertin,” said John Quisel, J.D., Ph.D., Chief Executive Officer and President of Disc. “The rapid enrollment of APOLLO underscores the urgent need and strong desire for a new treatment for EPP patients. We look forward to completing this study and continuing to engage with regulators to bring bitopertin to market.” APOLLO is a double-blind, placebo-controlled Phase 3 study of bitopertin in patients ages 12 and above with EPP and X-linked protoporphyria (XLP), that includes sites in the US, Canada, Europe, and Australia. The co-primary endpoints are average monthly total time in sunlight without pain between 10:00 and 18:00 during the last month of the 6-month treatment period and percent change from baseline in whole blood metal-free PPIX after 6 months of treatment. Additional study design details, including powering assumptions, are provided in the corporate presentation on Disc’s website. Data from APOLLO is expected in Q4 2026, after which a CRL response will be submitted with an FDA decision expected by mid-2027. About Bitopertin Bitopertin is an investigational, clinical-stage, orally administered inhibitor of glycine transporter 1 (GlyT1) that is designed to modulate heme biosynthesis. GlyT1 is a membrane transporter expressed on developing red blood cells and is required to supply sufficient glycine for heme biosynthesis and support erythropoiesis. Disc is developin...