Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
REGN3500 · 3 trials · 4 indications
| Arm | Type | Description |
|---|---|---|
| REGN3500 | EXPERIMENTAL | REGN3500: masked and randomized dosing regimen per protocol (part 1 only) |
| Dupilumab | EXPERIMENTAL | Dupilumab: masked and randomized dosing regimen per protocol (part 1 only) |
| REGN3500 plus dupilumab | EXPERIMENTAL | REGN3500 plus dupilumab: masked and randomized dosing regimen per protocol (part 1 only) |
| Placebo | EXPERIMENTAL | Placebo: masked and randomized dosing regimen per protocol (part 1 only) |
| Fluticasone propionate | ACTIVE_COMPARATOR | Fluticasone propionate: open label dosing regimen per protocol (part 2 only) |
| Cohort 1 | EXPERIMENTAL | REGN3500 low dose or placebo |
| Cohort 2 | EXPERIMENTAL | REGN3500 medium dose or placebo |
| Cohort 3 | EXPERIMENTAL | Dose regimen 3 of REGN3500 (IV) versus placebo |
| Cohort 4 | EXPERIMENTAL | Dose regimen 4 of REGN3500 (SC) versus placebo |
| Cohort 5 | EXPERIMENTAL | Dose regimen 5 of REGN3500 (IV) versus placebo |
| Name | Type | Description |
|---|---|---|
| REGN3500 | DRUG | Intravenous (IV) use |
| Dupilumab | DRUG | Subcutaneous (SC) use |
| Placebo | DRUG | Matching placebo |
| Fluticasone propionate | DRUG | Inhalation use |
KEY Inclusion Criteria: 1. Male or female aged between 18 and 60 years 2. Has a Body Mass Index {BMI) of 17 to 33 kg/m2 at pre-study screening 3. Has a history of mild allergic asthma for at least 6 months 4. Is a non-smoker or ex-smoker for at least 12 months KEY Exclusion Criteria: 1. Has a his...
REGN3500 is an investigational small molecule being studied for respiratory conditions, including asthma, moderate asthma, and allergic asthma. It has also been evaluated in healthy volunteers. As of the available data, REGN3500 is in Phase 1 clinical development and is not approved for any use.
REGN3500 is being developed by Regeneron Pharmaceuticals, Inc., a biopharmaceutical company traded on NASDAQ under the ticker REGN. The company has sponsored clinical trials of REGN3500 in healthy volunteers and in patients with asthma.
REGN3500 is in Phase 1 clinical development. All three clinical trials listed for REGN3500 are Phase 1 studies and have been completed. The drug is investigational and has not been approved by regulatory authorities.
REGN3500 has been studied in three completed Phase 1 trials: NCT02958436 in healthy volunteers in Belgium, NCT02999711 in adults with moderate asthma in the United Kingdom, and NCT03112577 in patients with allergic asthma in the United States and United Kingdom. These trials were randomized, double-blind, and controlled.
No, REGN3500 is not the same as dupilumab. REGN3500 is a small molecule, while dupilumab is a different biologic. However, one clinical trial, NCT03112577, studied REGN3500 in combination with dupilumab in patients with allergic asthma.