Disc Medicine: announces success in APOLLO Phase 3 trial

What happened

• Disc Medicine announced positive topline results from the APOLLO Phase 3 trial of bitopertin in erythropoietic protoporphyria, including X-linked protoporphyria, in a press release issued on Oct 19, 2026.
• The company also filed an investor presentation and hosted a webcast on Oct 19, 2026, to discuss the topline results.

Key details

• The randomized, double-blind trial enrolled 183 patients across the United States, Canada, Europe, and Australia, randomized 1:1 to 60 mg oral bitopertin once daily or placebo for 6 months.
• Co-primary endpoints met versus placebo: reduction in whole-blood metal-free protoporphyrin IX (PPIX) from baseline of -41.4% (p<0.0001) and increase in average monthly total time in light without pain during month 6 of +12.2 hours (p=0.0010).
• Secondary endpoints met versus placebo, including reduction in incidence rate of phototoxic reactions over 6 months (p<0.0001), increase in cumulative total time in light without pain over 6 months (p<0.0001), and increase in change from baseline in average daily sunlight exposure time to prodrome in adults (p=0.0077).
• Safety: dizziness was the most commonly reported treatment-emergent adverse event in the bitopertin group (50%), described as mild or moderate and generally transient; there were no TEAEs above Grade 3.
• The company plans to resubmit a new drug application to the U.S. Food and Drug Administration by the end of 2026, with an FDA decision anticipated by mid-2027.

Why it may matter

• Item 7.01 (regulation FD disclosure) reports the press release announcing the APOLLO topline results. Item 8.01 (other events) reports the webcast and presentation and the topline trial results.
• This filing does not show why the insider traded or why the company acted.