Disc Medicine will present pivotal Phase 2 data from its RALLY-MF trial evaluating DISC-0974 in patients with myelofibrosis-associated anemia at the upcoming American Society of Hematology (ASH) Annual Meeting in Orlando, Florida, December 6-9, 2025. The clinical-stage biopharmaceutical company announced two poster presentations showcasing progress in its hematologic disease pipeline.
"The highlight of our ASH presentations this year will be an initial look at data from RALLY-MF, our Phase 2 trial of DISC-0974 in anemia of myelofibrosis," said John Quisel, J.D., Ph.D., President and Chief Executive Officer of Disc Medicine. "Following the strong Phase 1b results we presented at ASH last year, we are eager to share an update on this program."
RALLY-MF Trial Design and Scope
The RALLY-MF Phase 2 study represents a significant advancement in evaluating DISC-0974, an anti-hemojuvelin antibody, for treating anemia associated with myelofibrosis. The trial encompasses results from patients across the spectrum of myelofibrosis anemia, testing DISC-0974 both as a standalone monotherapy and in combination with established JAK inhibitor backbone therapies.
The combination approach includes testing with ruxolitinib and momelotinib, two key JAK inhibitors currently used in myelofibrosis treatment. This comprehensive design allows researchers to evaluate DISC-0974's potential across different treatment paradigms and patient populations within the myelofibrosis landscape.
Presentation Details and Timeline
The RALLY-MF data will be presented as Publication Number 2042, titled "RALLY MF: A phase 2 Study of DISC-0974, an anti-hemojuvelin antibody, in patients with myelofibrosis and anemia." The poster session is scheduled for Saturday, December 6, from 5:30 pm to 7:30 pm EST, with Dr. Naseema Gangat, M.B.B.S., serving as the presenting author.
Management will conduct a dedicated call on Sunday, December 7 at 7:30 am EST to review highlights from the presented data and outline next steps in development. The call registration is available on Disc's investor relations website.
Expanded Pipeline Updates
Beyond the RALLY-MF data, Disc Medicine will present information on DISC-3405, another compound in its hematologic disease portfolio. The second poster, Publication Number 2053, focuses on "A phase 2, open-label study of the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of DISC-3405 in participants with polycythemia vera (PV)," with Dr. Marcus Carden, M.D., M.Sc., as the presenting author.
The company has outlined ambitious timelines for its DISC-3405 program, expecting initial readouts for both the Phase 2 trial in polycythemia vera and the Phase 1b trial in sickle cell disease during 2026.
Therapeutic Approach and Mechanism
Disc Medicine's approach targets fundamental biological pathways of red blood cell biology, specifically focusing on heme biosynthesis and iron homeostasis. DISC-0974's mechanism as an anti-hemojuvelin antibody represents a potentially first-in-class therapeutic approach for addressing hematologic diseases through iron regulation pathways.
The company's strategy involves building a portfolio of innovative therapeutic candidates designed to address a wide spectrum of hematologic diseases by targeting these core biological processes that govern red blood cell function and iron metabolism.
Additional Clinical Data Presentations
Concurrent with the ASH presentations, Disc Medicine will also present data from its Phase 1b trial of DISC-0974 in patients with chronic kidney disease and anemia at the 2025 American Society of Nephrology (ASN) Kidney Week in Houston, Texas, November 6-9, 2025. This presentation will provide updates from the randomized, placebo-controlled study in non-dialysis-dependent chronic kidney disease patients, including safety, tolerability, pharmacokinetics, and pharmacodynamic markers such as changes to hepcidin, iron, and hematologic parameters.
