DISC-0974 / Disc Medicine, AbbVie - LARVOL DELTA

A PHASE 1B/2 STUDY OF DISC-0974, AN ANTI-HEMOJUVELIN ANTIBODY, IN PATIENTS WITH MYELOFIBROSIS AND ANEMIA (EHA 2025) - P1/2 | "DISC-0974 demonstrated acceptable safety and tolerability at evaluated dose levels. Hematologic responses were achieved in all participants regardless of concomitant JAK-inhibitor use. Sustained hepcidin reduction with DISC-0974 increased serum iron that preceded hematological response."

Clinical • P1/2 data • Anemia • Dermatology • Fatigue • Hematological Disorders • Infectious Disease • Musculoskeletal Pain • Myelofibrosis • Pain

Study of DISC-0974-201 in Participants With IBD and Anemia (clinicaltrials.gov) - P2 | N=21 | Recruiting | Sponsor: Disc Medicine, Inc | Not yet recruiting ➔ Recruiting

Enrollment open • Anemia • Gastroenterology • Gastrointestinal Disorder • Hematological Disorders • Immunology • Inflammation • Inflammatory Bowel Disease

Recent Highlights and Anticipated Milestones: DISC-0974: Anti-Hemojuvelin Antibody (Hepcidin Suppression) (GlobeNewswire) - "Phase 2 study in patients with inflammatory bowel disease (IBD) and anemia initiated in Q1 2026 with initial data expected in 2027."

P2 data • Trial status • Anemia • Inflammatory Bowel Disease

Disc Medicine’s RALLY-IBD Trial Puts a Spotlight on Anemia Relief in IBD Patients (TipRanks) - "The trial tests DISC-0974, an injectable drug given under the skin. It is designed to improve anemia of inflammation in people with IBD, potentially reducing the need for transfusions or iron infusions and offering a more convenient option....Participants in the active arm receive 60 mg of DISC-0974 every 28 days for three doses, while the control arm gets placebo on the same schedule. The primary goal is treatment focused, looking at safety and early signs of benefit on anemia rather than long‑term outcomes."

Trial status • Anemia • Inflammatory Bowel Disease

ANTI-HEMOJUVELIN MONOCLONAL ANTIBODY REVERSES ANEMIA AND EXERTS DISEASE-MODIFYING EFFECTS IN A MOUSE MODEL OF INFLAMMATORY BOWEL DISEASE (CCCongress 2026) - P1, P1/2 | "Collectively, DBIO-100 reversed anemia and iron deficiency and exerted disease-modifying, anti-inflammatory effects in DSS-induced colitis. These results support DISC-0974 as a promising therapeutic for anemia in IBD, either as monotherapy or in combination with mesalamine."

Preclinical • Anemia • Chronic Kidney Disease • Colon Cancer • Colorectal Cancer • Gastroenterology • Gastrointestinal Disorder • Hematological Disorders • Immunology • Inflammation • Inflammatory Bowel Disease • Myelofibrosis • Nephrology • Renal Disease • IL6 • TNFA

Study of DISC-0974-201 in Participants With IBD and Anemia (clinicaltrials.gov) - P2 | N=21 | Not yet recruiting | Sponsor: Disc Medicine, Inc

New P2 trial • Anemia • Gastroenterology • Gastrointestinal Disorder • Hematological Disorders • Immunology • Inflammation • Inflammatory Bowel Disease

Key Business Objectives and Milestones for 2026:…DISC-0974: Anti-hemojuvelin Antibody (Hepcidin Suppression) (GlobeNewswire) - "(i) Progress ongoing Phase 2 MF anemia trial with updated data expected H2 2026; (ii) Conduct End of Phase 2 meeting with the FDA about DISC-0974 in MF anemia in H2 2026; (iii) Initiate a Phase 2 study of DISC-0974 in patients with anemia and inflammatory bowel disease (IBD)."

FDA event • New P2 trial • P2 data • Anemia • Inflammatory Bowel Disease • Myelofibrosis

Summary of Key Achievements During 2025 (GlobeNewswire) - "Issuance of a Composition of Matter patent for DISC-0974, providing patent exclusivity until 2041, not including potential extensions."

Patent • Anemia • Myelofibrosis

DISC-0974-103: Study of DISC-0974 to Assess the Safety, Tolerability, PK and PD of DISC-0974 in Participants With CKD and Anemia (clinicaltrials.gov) - P1 | N=50 | Active, not recruiting | Sponsor: Disc Medicine, Inc | Trial primary completion date: Sep 2025 ➔ Jan 2026

Trial primary completion date • Anemia • Chronic Kidney Disease • Hematological Disorders • Nephrology • Renal Disease

RALLY MF: A phase 2 Study of DISC-0974, an anti-hemojuvelin antibody, in patients with myelofibrosis and anemia (ASH 2025) - P1/2 | "A stable dose ofconcomitant hydroxyurea and/or Janus kinase (JAK) inhibitor (ruxolitinib and fedratinib for primarycohorts; momelotinib and pacritinib for exploratory cohort) was allowed. Based on these initial data, the protocol was amended to allowconcomitant momelotinib or pacritinib in all cohorts. Preliminary results, including baselinecharacteristics, PD, and hematologic responses across all cohorts, will be presented."

Clinical • P2 data • Anemia • Hematological Disorders • Immunology • Myelofibrosis

DISC-0974: “Hematologic responses achieved across transfusion cohorts and regardless of concomitant JAKi use“; Myelofibrosis (Disc Medicine) - ASH 2025

P2 data • Hematological Malignancies • Myelofibrosis • Oncology

Disc Medicine Presents Positive Initial Data from RALLY-MF Phase 2 Trial in Patients with Myelofibrosis (MF) and Anemia at the 67th American Society of Hematology (ASH) Annual Meeting (GlobeNewswire) - "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)....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....Additional data to be shared in H2 2026."

P2 data • Anemia • Myelofibrosis

Anti-Hemojuvelin Monoclonal Antibody Alleviated Anemia Induced By Ruxolitinib Treatment in Mice (ASH 2024) - P1, P1/2 | "DISC-0974 is a humanized anti-hemojuvelin (HJV) monoclonal antibody. These data highlight the therapeutic potential of anti-HJV monoclonal antibodies in the treatment of anemia in diseases such as MF, in which ruxolitinib is a commonly used therapy that may be a significant additional factor in the development of anemia. The combination therapy may enhance the benefits of JAK inhibitors, particularly in the patient population with MF and anemia."

Preclinical • Anemia • Chronic Kidney Disease • Gastrointestinal Disorder • Hematological Disorders • Hematological Malignancies • Myelofibrosis • Nephrology • Oncology • Renal Disease

Molecular and Cytokine Correlates of Anemia Response to Treatment with DISC-0974 (An Anti-Hemojuvelin Antibody) in Non-Transfusion-Dependent Patients with Myelofibrosis (ASH 2024) - P1/2 | "Twelve (60%) patients were on DISC-0974 monotherapy while 9 (40%) received concomitant ruxolitinib (N=5), pacritinib (N=1), or hydroxyurea (N=3). Elevated inflammatory cytokines in MF are often associated with increased hepcidin levels (AJH 2013 : 88 : 312) and this might explain their association with a higher response rate to DISC-0974, observed in the current study. Regardless, it is important to note that these observations represent preliminary data from a subset of patients from an ongoing clinical trial."

Clinical • Anemia • Hematological Disorders • Myelofibrosis • ASXL1 • CALR • IL18 • IL2RA • IL6 • SF3B1 • SRSF2 • U2AF1

A Phase 1b Double-Blind, Placebo-Controlled Study of DISC-0974, an Anti-Hemojuvelin Antibody, in Patients with Non-Dialysis Dependent Chronic Kidney Disease and Anemia (ASH 2023) - P1 | "Secondary endpoints include changes in serum hepcidin-25, iron, TSAT, ferritin, Hgb, and other hematology biomarkers. Enrollment is currently ongoing, and available study results will be presented at the meeting."

Clinical • P1 data • Anemia • Chronic Kidney Disease • Hematological Disorders • Immunology • Nephrology • Renal Disease

Anti-Hemojuvelin Monoclonal Antibody DISC-0974 Elicits a Durable and Consistent Response with Repeated Dosing in Cynomolgus Monkeys (ASH 2023) - "Increases in serum iron (up to approximately 3-fold baseline) (Figure 1) and TSAT (>90%), representative of PD activity, correlated with systemic exposures of DISC-0974, with similar activity maintained after each of the 7 monthly doses. ConclusionOverall, these data demonstrate that DISC-0974 is well tolerated after repeated monthly exposure in cynomolgus monkeys, and an appropriate and durable PK/PD profile was observed, supporting clinical development of chronic once-monthly dosing."

Anemia • Chronic Kidney Disease • Hematological Disorders • Myelofibrosis • Nephrology • Renal Disease

A Phase 1b Trial of DISC-0974, an Anti-Hemojuvelin Antibody, in Patients with Myelofibrosis and Anemia (ASH 2023) - P1/2 | "A stable dose of hydroxyurea and/or Janus kinase (JAK) inhibitor is allowed on trial. As of August 1, 2023, enrollment and dose escalation are ongoing. Safety, PK, and PD data from at least the first two cohorts will be presented."

Clinical • P1 data • Anemia • Hematological Disorders • Immunology • Myelofibrosis

A Phase 1b, Double-Blind, Placebo-Controlled Study of DISC-0974, an Anti-Hemojuvelin Antibody, in Patients with Nondialysis-Dependent CKD and Anemia (KIDNEY WEEK 2025) - P1 | "Multiple-dose cohort enrollment is ongoing to evaluate optimal regimen for sustained Hgb increase. Complete SAD and available multiple-dose cohort data are forthcoming."

Clinical • P1 data • Anemia • Chronic Kidney Disease • Hematological Disorders

Disc Medicine Announces Presentation of Initial Data from RALLY-MF Phase 2 Trial in Patients with Myelofibrosis (MF) and Anemia at the 67th American Society of Hematology (ASH) Annual Meeting (GlobeNewswire) - "We will also present a poster on the design of our ongoing Phase 2 trial of DISC-3405 in polycythemia vera. We expect to share an initial readout for this trial, as well as for the Phase 1b trial of DISC-3405 in sickle cell disease, in 2026."

Clinical data • Clinical protocol • Anemia • Myelofibrosis • Polycythemia Vera • Sickle Cell Disease

Anti-Hemojuvelin Monoclonal Antibody Reverses Anemia and Exerts Disease-Modifying Effects in a Mouse Model of Inflammatory Bowel Disease (ASH 2024) - P1, P1/2 | "Of note, while some beneficial effects of DBIO-100 were equivalent to those of mesalamine, others showed superiority. The findings highlight the therapeutic potential of DISC-0974 in the treatment of anemia of chronic inflammatory disease such as IBD."

Preclinical • Anemia • Chronic Kidney Disease • Gastroenterology • Gastrointestinal Disorder • Hematological Disorders • Immunology • Inflammation • Inflammatory Bowel Disease • Myelofibrosis • Nephrology • Renal Disease • IL6 • TNFA

A Phase 1b Study of DISC-0974, an Anti-Hemojuvelin Antibody, in Patients with Myelofibrosis and Anemia (ASH 2024) - P1/2 | "A stable dose of concomitant hydroxyurea and/or Janus kinase (JAK) inhibitor was allowed. Sustained hepcidin reduction with DISC-0974 led to increased serum iron that preceded hematological response. Additional Phase 1b data, including longer follow-up, will be presented."

Clinical • P1 data • Anemia • Hematological Disorders • Immunology • Musculoskeletal Pain • Myelofibrosis • Pain

Initial data from Phase 2 RALLY-MF trial of DISC-0974 in patients with anemia of myelofibrosis (MF) to be presented…with topline data expected in 2026 (GlobeNewswire)

P2 data • Anemia • Myelofibrosis

DISC-0974: Anti-Hemojuvelin Antibody (Hepcidin Suppression) (GlobeNewswire) - "Phase 2 study in patients with inflammatory bowel disease (IBD) and anemia anticipated to begin in Q1 2026."

New P2 trial • Inflammatory Bowel Disease

Disc Medicine to Present Data from Phase 1b Trial of DISC-0974 in Patients with Chronic Kidney Disease (CKD) and Anemia at 2025 American Society of Nephrology (ASN) Kidney Week (Disc Medicine Press Release) - "The poster presentation will provide a data update from the Phase 1b, randomized, placebo-controlled study of DISC-0974 in patients with non-dialysis-dependent chronic kidney disease (NDD-CKD) and anemia. This study was designed to assess the safety, tolerability and pharmacokinetics of single ascending and multiple doses of DISC-0974, as well as measures of pharmacodynamic activity, including changes to hepcidin, iron, and hematologic parameters."

P1 data • Chronic Kidney Disease

Individualizing Treatment Selection in MF (SOHO 2025) - P3 | "These include the activin receptor ligand trap luspatercept, the telomerase inhibitor imetelstat, the selective inhibitor of nuclear export selinexor, the human double minute 2 inhibitor navtemadlin, and the bromodomain and extra-terminal protein inhibitor pelabresib...Elritercept — another activin receptor ligand trap — and the anti-hemojuvelin antibody DISC-0974 are being developed for anemia of MF...Currently, these patients are observed or managed for thrombotic risk similarly to those with essential thrombocythemia (ET) — receiving hydroxyurea for control of cytoses, ruxolitinib for symptoms, or interferon for long-term disease modification. Encouraging data on ruxolitinib in patients with intermediate-1-risk MF, along with analyses from the COMFORT trials demonstrating the benefits of early initiation of ruxolitinib in patients with intermediate-2/high-risk MF and intriguing evidence of event-free survival (EFS) improvement with both ruxolitinib and..."

Clinical • Essential Thrombocythemia • Hematological Malignancies • Myelodysplastic Syndrome • Myelofibrosis • Myeloproliferative Neoplasm • Non-melanoma Skin Cancer • Oncology • Polycythemia Vera • Skin Cancer • Solid Tumor • ACVR1 • IRAK1