Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
REGN7508 · 11 trials · 7 indications
Part 1
Part 1
Part 2
Part 2
Cohort 1
Cohort 1 and 2
Defined as the composite of International Society on Thrombosis and Haemostasis (ISTH) major bleeding, ISTH Clinically Relevant Non-Major (CRNM) bleeding, or minor bleeding
Composite endpoint that includes asymptomatic deep DVT (deep venous thrombosis) detected by unilateral venography of the operated leg; confirmed symptomatic DVT of either leg; confirmed fatal or nonfatal pulmonary embolism (PE) including unexplained death for which PE cannot be ruled out.
Treatment-emergent adverse events are defined as those that are not present at baseline or represent the exacerbation of a pre-existing condition during the on-treatment period.
Treatment-emergent adverse events are defined as those that are not present at baseline or represent the exacerbation of a pre-existing condition during the on-treatment period.
| Arm | Type | Description |
|---|---|---|
| REGN7508 | EXPERIMENTAL | - |
| Apixaban | ACTIVE_COMPARATOR | - |
| REGN9933 | EXPERIMENTAL | - |
| Placebo | PLACEBO_COMPARATOR | - |
| REGN7508 + Placebo | EXPERIMENTAL | - |
| Apixaban + Placebo | ACTIVE_COMPARATOR | - |
| Cohort 1 | EXPERIMENTAL | - |
| Cohort 2 | EXPERIMENTAL | - |
| REGN7508 and Placebo | EXPERIMENTAL | - |
| Placebo and ASA | ACTIVE_COMPARATOR | - |
| IV REGN7508 | EXPERIMENTAL | - |
| IV Placebo, SC REGN7508 | EXPERIMENTAL | - |
| IV Placebo, apixaban | ACTIVE_COMPARATOR | - |
| IV Placebo, enoxaparin | ACTIVE_COMPARATOR | - |
| Enoxaparin | ACTIVE_COMPARATOR | - |
| Cohort 1 Lowest IV Dose | EXPERIMENTAL | Randomized 3:1 |
| Cohort 2 Low IV Dose | EXPERIMENTAL | Randomized 3:1 |
| Cohort 3 Mid IV Dose | EXPERIMENTAL | Randomized 3:1 |
| Cohort 4 High IV Dose | EXPERIMENTAL | Randomized 3:1 |
| Cohort 5 Higher IV Dose | EXPERIMENTAL | Randomized 3:1 |
| Cohort 6 High SC Dose | EXPERIMENTAL | Randomized 3:1 |
| Cohort 7 Higher SC Dose | EXPERIMENTAL | Randomized 3:1 |
| Optional: Cohort 8 Highest IV or SC Dose | EXPERIMENTAL | Randomized 3:1 |
| Cohort 9 High SC Dose | EXPERIMENTAL | Randomized 3:1 |
| Optional: Cohort 10 Highest SC Dose | EXPERIMENTAL | Randomized 3:1 |
| Name | Type | Description |
|---|---|---|
| REGN7508 | DRUG | Administered per the protocol |
| Apixaban | DRUG | Administered per the protocol |
| REGN9933 | DRUG | Administered per the protocol |
| Placebo | DRUG | Administered per the protocol |
| Rivaroxaban | DRUG | Administered per the protocol |
| Acetylsalicylic Acid (ASA) | DRUG | Administered per the protocol |
| Enoxaparin | DRUG | Administered per the protocol |
| REGN7508 (IV) | DRUG | Administered sequential, ascending single intravenous (IV) dose |
| REGN7508 (SC) | DRUG | Administered sequential, ascending single subcutaneous (SC) dose |
| Matching Placebo (IV) | DRUG | Administered sequential, ascending single intravenous (IV) dose |
| Matching Placebo (SC) | DRUG | Administered sequential, ascending single subcutaneous (SC) dose |
Key Inclusion Criteria: 1. Has an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 2 at the time of screening and day 1 prior to first dose of study intervention 2. In Part 1 participants with cancer and Part 2 participants: Histologically confirmed diagnosis of malignant solid ...
REGN7508 is an investigational small molecule being developed for cardiovascular conditions including venous thromboembolism (VTE), peripheral artery disease (PAD), and cancer-associated thrombosis. It is being studied for preventing blood clots after knee replacement surgery and for reducing adverse vascular outcomes in patients with PAD.
REGN7508 targets Factor XI, a protein involved in blood clotting. By inhibiting Factor XI, the drug aims to prevent thrombotic events while potentially reducing bleeding risk compared to existing anticoagulants.
REGN7508 is being developed by Regeneron Pharmaceuticals, Inc., a biopharmaceutical company traded on NASDAQ under the ticker REGN. Regeneron is conducting multiple clinical trials to evaluate the drug's safety and efficacy.
REGN7508 is in Phase 3 clinical development. It is being evaluated in multiple Phase 3 trials for venous thromboembolism prophylaxis and peripheral artery disease. The drug is investigational and has not been approved by regulatory authorities.
REGN7508 is being studied in several trials including NCT07015905, a Phase 3 study comparing it to apixaban and enoxaparin after knee replacement; NCT07318610 for peripheral artery disease; and NCT07697599 for VTE prophylaxis with PICC lines. A Phase 2 trial (NCT06454630) has been completed.
No, REGN7508 and REGN9933 are different investigational drugs. However, they are being studied together in a Phase 3 trial (NCT07697599) for venous thromboembolism prophylaxis in patients with a peripherally inserted central catheter.