Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
DISC-0974 · 4 trials · 12 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. |
| Healthy Volunteer: Single Ascending Dose of DISC-0974 | EXPERIMENTAL | Single Intravenous (IV) or Subcutaneous (SC) ascending dose in healthy volunteers |
| Healthy Volunteer: Single Ascending Dose of Placebo | EXPERIMENTAL | Single Intravenous (IV) or Subcutaneous (SC) ascending dose in healthy volunteers |
| 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 by Disc Medicine for anemia associated with myelofibrosis, myelodysplastic syndromes, chronic kidney disease, and inflammatory bowel disease. It is currently in Phase 1 and Phase 2 clinical trials, and has received Fast Track designation from the FDA.
DISC-0974 is a small molecule therapeutic developed by Disc Medicine. Its molecular target has not been disclosed in available clinical trial information. The drug is being studied for its effects on anemia in several conditions, including myelofibrosis and chronic kidney disease.
DISC-0974 is developed by Disc Medicine, Inc., a biopharmaceutical company traded under the ticker symbol IRON on the NASDAQ. The company is conducting clinical trials to evaluate the drug's safety and efficacy in multiple anemic patient populations.
DISC-0974 is in Phase 1 and Phase 2 clinical development. Phase 1 trials have been completed in healthy volunteers and in patients with chronic kidney disease and anemia. A Phase 2 trial is currently recruiting participants with inflammatory bowel disease and anemia.
DISC-0974 has been studied in several clinical trials. NCT04999527 was a completed Phase 1 trial in healthy volunteers. NCT05320198 is a recruiting Phase 1 trial in myelofibrosis or myelodysplastic syndrome with anemia. NCT05745883 was a completed Phase 1 trial in chronic kidney disease with anemia. NCT07368972 is a recruiting Phase 2 trial in inflammatory bowel disease with anemia.
DISC-0974 is the primary name used in clinical trials and regulatory filings. No alternative names have been reported in the available clinical trial information. It is an investigational small molecule and not yet approved by regulatory authorities.