Disc Medicine reports early Phase 2 data for DISC-3405 in polycythemia vera

Disc Medicine, Inc. disclosed on September 9, 2026 that it had presented data from the RESTORE-PV Phase 2 trial of DISC-3405 in patients with polycythemia vera, showing that the drug raised hepcidin levels and lowered serum iron, which in turn was linked to fewer phlebotomies, steadier hematocrit control, and eased symptoms in trial participants.¹ The results were shown at the 2026 SOHO annual meeting in Houston.

The study design: the trial is a Phase 2, multi-center, open-label study that signed up 40 adult patients with PV, split evenly into Cohort A and Cohort B with 20 participants each.¹ After an observation period of 4 to 12 weeks, patients go through 12 weeks of dose escalation, then get DISC-3405 injected under the skin at 300 mg every two weeks (Cohort A) or every four weeks (Cohort B) for 20 weeks, with an option for 20 more weeks at the same dose.¹

At the data cutoff, every Cohort A participant had received dosing and 13 had reached the 26-week mark, while 18 of 20 Cohort B patients had been dosed.¹ For the 13 patients who finished 26 weeks, average phlebotomy events fell from 4.0 over 26 weeks at baseline to 0.6 over the following 26 weeks (p<0.0001), with 61.5% staying phlebotomy-free the whole time, and among nine patients who completed the first maintenance stretch (weeks 12 to 32), 77.8% avoided phlebotomy entirely.¹ Hematocrit stayed below 45% on average through week 26 in Cohort A, alongside early gains in symptom scores.¹ On safety, the treatment was generally tolerated well, with adverse events tied to the underlying disease and only mild, self-resolving injection site reactions.¹

Looking ahead, Disc plans to give a further update on RESTORE-PV and share initial Phase 1b data in sickle cell disease by the end of 2026.¹ Separately, the company said it expects to report feedback from an end-of-phase-2 FDA meeting and outline pivotal development plans for selcodebart in anemia of myelofibrosis by year end.¹