On December 6, 2025 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, reported positive initial data from the RALLY-MF Phase 2 trial of DISC-0974 in anemia of MF at the ASH (Free ASH Whitepaper) Annual Meeting in Orlando, FL. The data demonstrated that treatment with DISC-0974 resulted in substantial reductions in hepcidin and increases in iron levels translating to positive impact on clinically meaningful measures of anemia across a broad range of patient types.
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"We are excited that we continue to see robust hematologic responses to DISC-0974 regardless of background JAK inhibitor therapy," said John Quisel, J.D., Ph.D., President and Chief Executive Officer of Disc Medicine. "It is also encouraging to see these hematologic improvements translating into reduced transfusion burden and fatigue. We look forward to advancing this program with the goal of addressing a significant unmet need as anemia is one of the key manifestations of MF and there is currently no therapy approved to treat anemia in this population."
This ongoing Phase 2 open-label study had enrolled 47 adult patients with MF and anemia as of the data cutoff date of October 16, including 34 patients with sufficient follow up to be included in the responder analysis (non-transfusion dependent receiving no transfusions (nTD, n=24), transfusion dependent with low transfusion burden (TD Low, n=7) and transfusion dependent with high transfusion burden (TD High, n=3)). The trial was comprised of both patients receiving concomitant JAK inhibitor therapy (n=18) and not receiving JAK inhibitor therapy (n=16). DISC-0974 was administered subcutaneously at 50 mg every 4 weeks for up to 6 treatments. Initial results demonstrated:
Consistent, substantial decreases in hepcidin reaching >75% reduction from baseline and corresponding increases in serum iron
63% of baseline nTD patients achieved a hemoglobin increase of ≥1 g/dL for ≥12 weeks (overall response) and 50% had an increase of ≥1.5 g/dL for ≥12 weeks (major response)
71% of TD Low patients achieved transfusion independence (TI, major response) over a 16-week period
67% of TD High patients with at least 85 days on study achieved a ≥50% reduction in transfusion requirement (overall response)
Initial data for additional n=3 TD High patients trending towards major response of TI >12 weeks
50% of patients receiving concomitant JAK inhibitor therapy achieved a major hematologic response
Dosing with DISC-0974 was associated with improvements in FACIT-Fatigue scores in nTD and TD Low participants
DISC-0974 was generally well-tolerated. Diarrhea and urinary tract infections, neither considered serious, were the only adverse events (AE) that were considered related to DISC-0974 and reported in two or more subjects. The majority of AEs were not considered related to DISC-0974.
Additional data to be shared in H2 2026
Disc also shared a poster overviewing the trial design for the ongoing Phase 2 study of the anti-TMPRSS6 antibody DISC-3405 in polycythemia vera requiring frequent phlebotomy.
Management will host a call during the ASH (Free ASH Whitepaper) meeting to review highlights of the presented data and plans for next steps in development on Sunday, December 7 at 7:30am EST. Please register for the event on the Events and Presentations page of Disc’s website (View Source).
(Press release, Disc Medicine, DEC 6, 2025, View Sourcenews-releases/news-release-details/disc-medicine-presents-positive-initial-data-rally-mf-phase-2 [SID1234661198])