DISC-3405 - (RESTORE-PV)

September 9, 2026: Disc Medicine (NASDAQ: IRON) reported positive initial Phase 2 RESTORE-PV data for DISC-3405 in polycythemia vera at the 2026 SOHO meeting. In the 40-patient, open-label study, Cohort A patients received 300 mg subcutaneous DISC-3405 every 2 weeks and Cohort B every 4 weeks. At data cutoff, efficacy was reported for Cohort A. DISC-3405 showed dose-proportional PK, increased hepcidin, reduced serum iron, increased ferritin, and maintained mean hematocrit below 45% through week 26 with initial symptom improvement. Among 13 Cohort A patients completing 26 weeks, mean phlebotomy events fell from 4.0 at baseline to 0.6 post-Day 1 (p<0.0001); 61.5% remained phlebotomy-free through 26 weeks, and 77.8% of 9 patients completing weeks 12-32 were phlebotomy-free during that maintenance period. Safety was described as generally well tolerated, with mild, self-limited injection site reactions. An oral presentation is scheduled for September 10, and the company plans a further RESTORE-PV update plus initial Phase 1b sickle cell disease data for DISC-3405 by year-end 2026.

Also at SOHO, Disc presented an encore of positive Phase 2 RALLY-MF results for selcodebart (DISC-0974) in anemia of myelofibrosis and said it expects FDA end-of-Phase 2 feedback and pivotal development plans by the end of 2026.