Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
DISC-3405 · 3 trials · 3 indications
Proportion of participants with treatment-emergent adverse events
Proportion of participants with changes in vital signs
Proportion of participants with changes in physical examinations
Proportion of participants with changes in electrocardiograms (ECGs)
Proportion of participants with changes in clinical laboratory results
Proportion of participants with treatment-emergent adverse events (TEAEs), changes in vital signs, changes in physical examinations, changes in electrocardiograms (ECGs), and changes in clinical laboratory results
| Arm | Type | Description |
|---|---|---|
| Within-participant dose escalation | EXPERIMENTAL | This is an open-label, multicenter, within-participant dose escalation study examining up to 2 dose levels of DISC-3405. |
| Single Ascending Dose of DISC-3405 | EXPERIMENTAL | - |
| Single Ascending Dose of Placebo | PLACEBO_COMPARATOR | - |
| Multiple Ascending Dose of DISC-3405 | EXPERIMENTAL | - |
| Multiple Ascending Dose of Placebo | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| DISC-3405 | DRUG | DISC-3405 is administered subcutaneously. |
| Placebo | DRUG | Placebo is administered as a single dose IV infusion or subcutaneous injection |
Inclusion Criteria: 1. Aged 18 years or older at the time of signing the informed consent form (ICF). 2. Meet revised 2022 World Health Organization (WHO) criteria for the diagnosis of PV. 3. Complete blood count values at Screening of HCT \<45% or HCT \<48% if followed by a phlebotomy within 2 wee...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Protagonist Therapeutics, Inc. | PTGX | 2 | PHASE3 | Rusfertide |
| Merck & Co., Inc. | MRK | 1 | PHASE3 | Bomedemstat |
| Disc Medicine, Inc. | IRON | 1 | PHASE2 | DISC-3405 |
| Prelude Therapeutics, Inc. | PRLD | 1 | PHASE1 | PRT12396 |
| Novartis AG Sponsored ADR | NVS | 1 | - | Undisclosed |
DISC-3405 is an investigational small molecule being studied for Polycythemia Vera (PV) and Sickle Cell Disease (SCD). It is developed by Disc Medicine, Inc. (NASDAQ: IRON). The drug is also being evaluated in healthy volunteers to assess its safety and pharmacokinetics.
DISC-3405 is developed by Disc Medicine, Inc., a biopharmaceutical company trading on NASDAQ under the ticker IRON. The company is conducting clinical trials of DISC-3405 in the United States across multiple indications.
DISC-3405 is in Phase 1 clinical development for Sickle Cell Disease and has completed a Phase 1 study in healthy volunteers. A Phase 2 study in Polycythemia Vera is active but not recruiting. The drug has received Orphan Drug designation from the FDA.
DISC-3405 is being studied in three clinical trials: NCT06050915, a completed Phase 1 study in 64 healthy volunteers; NCT06985147, an active Phase 2 open-label study in 60 participants with Polycythemia Vera; and NCT07187973, a recruiting Phase 1b open-label study in 24 participants with Sickle Cell Disease.
DISC-3405 is not FDA approved. It is an investigational drug currently in clinical development. The FDA has granted Orphan Drug designation for DISC-3405, which provides certain development incentives, but the drug remains investigational and has not received marketing approval.