Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
DISC-0974 · 3 trials · 11 indications
Assessed by treatment-emergent adverse events
The blood testing will include a hematology panel, blood chemistry panel, serology/virology panel, biomarker assessments, PK assessments, and Anti-Drug Antibodies
The urine testing will include a urinalysis
Defined as the absence of packed red blood cell (PRBC) transfusions over any rolling 12-week interval during the treatment period with a minimum hemoglobin (Hgb) of 7 g/dL. Participants meeting this criterion will be considered to have a major response to treatment.
Defined as the absence of PRBC transfusions over any rolling 16-week interval during the treatment period with a minimum Hgb of 7 g/dL. Participants meeting this criterion will be considered to have a major response to treatment.
Defined as the composite of the absence of transfusions over any rolling 12-week period and a concomitant mean Hgb increase of ≥1.5 g/dL over baseline. Participants meeting this criterion will be considered to have a major response to treatment.
| Arm | Type | Description |
|---|---|---|
| Active | EXPERIMENTAL | DISC-0974 60 mg (n = 14) administered subcutaneously (SC) every 28 days for 3 doses |
| Placebo | PLACEBO_COMPARATOR | Placebo (n = 7) administered SC every 28 days for 3 doses |
| Phase 1b Single Dose | EXPERIMENTAL | Single dose of DISC-0974 |
| Single Dose of Placebo | PLACEBO_COMPARATOR | Single dose of placebo |
| Phase 1b Multiple Doses | EXPERIMENTAL | Multiple doses of DISC-0974 |
| Multiple Doses of Placebo | PLACEBO_COMPARATOR | Multiple doses of placebo |
| Phase 1b: Dose Escalation | EXPERIMENTAL | In the Phase 1b (dose-escalation) portion of the study, DISC-0974 will be administered subcutaneously every 4 weeks. |
| Phase 2: Expansion | EXPERIMENTAL | In the Phase 2 (expansion) portion of the study, DISC-0974 will be administered subcutaneously every 4 weeks. |
| Name | Type | Description |
|---|---|---|
| DISC-0974 | DRUG | DISC-0974 is administered subcutaneously. |
| Placebo | DRUG | Placebo is administered subcutaneously |
Inclusion Criteria: Participants must meet all the following criteria at screening (unless otherwise specified) to be eligible for enrollment in the study: 1. Aged ≥18 years at the time of signing informed consent. 2. Established diagnosis of IBD (CD, UC, or IBD-unclassified) based on documented f...
DISC-0974 is an investigational small molecule being developed for anemia associated with chronic kidney disease, inflammatory bowel disease, and myelofibrosis. Disc Medicine is studying it in adults with these conditions who have anemia, including anemia of chronic kidney disease and anemia related to myelofibrosis or myelodysplastic syndrome.
DISC-0974 targets hemojuvelin, also known as HJV. Hemojuvelin is involved in the regulation of hepcidin, a hormone that controls iron availability. By targeting HJV, DISC-0974 is designed to affect iron metabolism and red blood cell production in patients with anemia linked to chronic inflammation or bone marrow disorders.
DISC-0974 is being developed by Disc Medicine, Inc., which trades under the ticker IRON. The company is running clinical studies of the drug in anemia associated with chronic kidney disease, inflammatory bowel disease, and myelofibrosis or myelodysplastic syndrome.
DISC-0974 is in clinical development, with Phase 1 studies completed or ongoing and a Phase 2 study now recruiting. It is investigational and has not been approved by the FDA. The FDA has granted DISC-0974 a Fast Track designation.
DISC-0974 has been studied in NCT05745883, a completed Phase 1 trial in chronic kidney disease and anemia, and NCT05320198, a recruiting Phase 1 trial in myelofibrosis or myelodysplastic syndrome and anemia. A Phase 2 trial, NCT07368972, is recruiting participants with inflammatory bowel disease and anemia in the United States.
Yes. DISC-0974 trials have used randomized, double-blind, placebo-controlled designs. The studies enroll adults aged 18 years and older and do not include healthy volunteers, focusing instead on patients with anemia related to chronic kidney disease, inflammatory bowel disease, or myelofibrosis.