(RTTNews) – Disc Medicine, Inc. (IRON), a clinical-stage biopharmaceutical company, presented positive initial results from the RESTORE-PV Phase 2 trial of DISC-3405 in patients with polycythemia vera (PV) at the 2026 Society of Haematology/Oncology (SOHO) annual meeting in Houston, TX.
Polycythemia vera (PV) is a rare blood cancer characterised by the uncontrolled overproduction of red blood cells. Excess red blood cell production thickens the blood, increasing the risk of cardiovascular and thromboembolic events, including heart attack and stroke.
DISC-3405 is an investigational, anti-TMPRSS6 (Transmembrane Serine Protease 6, also known as Matriptase-2) monoclonal antibody designed to increase hepcidin production and suppress serum iron.
Treatment with DISC-3405 increased hepcidin and lowered serum iron, resulting in reduced phlebotomy (blood-removal procedures), controlled hematocrit (red-cell production), and improved symptom burden in patients with PV.
The Phase 2 multicenter, open-label RESTORE-PV trial enrolled 40 adult participants with PV, including 20 in Cohort A and 20 in Cohort B.
In the trial, patients underwent a 4- to 12-week observation period, followed by 12 weeks of dose escalation and 20 weeks of DISC-3405 treatment at 300 mg administered subcutaneously every two weeks (Cohort A) or every four weeks (Cohort B), with an option for up to 20 additional weeks of treatment.
Efficacy data were presented for Cohort A, and baseline and safety data were presented for Cohorts A and B.
Key Findings
Key findings across the escalation and maintenance periods included:
– Dose-proportional PK, elevation of hepcidin, reduction of serum iron, and increase in ferritin (Cohort A).
– Mean hematocrit maintained stably below 45% through week 26, which led to initial improvement in symptom burden (Cohort A).
– In addition, mean total phlebotomy events significantly decreased from 4.0 in 26 weeks at baseline to 0.6 in 26 weeks post-Day 1 (p0.0001).
– Through week 26, 61.5% of participants remained entirely phlebotomy-free post-baseline.
– DISC-3405 was generally well tolerated, with adverse events consistent with the underlying disease.
– Of those who completed the first maintenance period (weeks 12-32, n=9), 77.8% of participants remained phlebotomy-free during this period
– Disc plans to provide an update on RESTORE-PV, as well as initial data from the Phase 1b trial of DISC-3405 in sickle cell disease, by the end of 2026.
Disc also presented an encore analysis of positive Phase 2 RALLY-MF results for selcodebart (DISC-0974) in myelofibrosis(MF)-related anaemia and a new literature review highlighting the patient-reported burden of anaemia in MF.
Wedbush View and Stock Performance
In the first week of September, Wedbush analysts reiterated Disc Medicine at an Outperform Rating and raised the 12-month price target to $100 from $88.
IRON has traded between $40.00 and $99.50 over the last year. The stock closed Wednesday’s trade at $76.51, down 0.43%.
In after-hours trading, IRON was up 0.24% at $76.69.
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