Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
REGN10933+REGN10987 combination therapy · 2 trials · 1 indication
Time-weighted average daily change from Day 1 in viral load (log10 copies/mL), as measured by reverse transcription quantitative polymerase chain reaction (RT-qPCR) in nasopharyngeal (NP) swab samples.
Time-weighted average daily change from Day 1 to Day 7 in viral load (log10 copies/mL), as measured by reverse transcription quantitative polymerase chain reaction (RT-qPCR) in nasopharyngeal (NP) swab samples.
Percentage of participants who died or went on mechanical ventilation from Day 6 through Day 29 based on high viral load mFAS were reported.
Percentage of participants who died or went on mechanical ventilation from Day 6 through Day 29 based on seronegative mFAS were reported.
Percentage of participants who died or went on mechanical ventilation from Day 6 through Day 29 based on overall FAS were reported.
Percentage of participants who died or went on mechanical ventilation from Day 1 through Day 29 based on high viral load mFAS were reported.
Percentage of participants who died or went on mechanical ventilation from Day 1 through Day 29 based on seronegative mFAS were reported.
Percentage of participants who died or went on mechanical ventilation from Day 1 through Day 29 based on overall mFAS were reported.
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 observation period.
Infusion-related reactions are defined as any relevant adverse event that occurs during the infusion or up to day 4. The severity of adverse events (including test findings classified as adverse events) were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE).
Hypersensitivity reactions are defined as any relevant adverse event that occurs during the infusion or up to study day 29. The severity of adverse events (including test findings classified as adverse events) were graded according to NCI-CTCAE.
Cumulative incidence percentage was estimated using Kaplan-Meier method.
Cumulative incidence percentage was estimated using Kaplan-Meier method.
| Arm | Type | Description |
|---|---|---|
| IV Dose 1 | EXPERIMENTAL | Combination therapy intravenous (IV) single dose |
| IV Dose 2 | EXPERIMENTAL | Combination therapy IV single dose |
| IV Dose 3 | EXPERIMENTAL | Combination therapy IV single dose |
| IV Dose 4 | EXPERIMENTAL | Combination therapy IV single dose |
| Placebo IV Dose | EXPERIMENTAL | Matching placebo IV single dose |
| SC Dose 1 | EXPERIMENTAL | Combination therapy subcutaneous (SC) single dose |
| SC Dose 2 | EXPERIMENTAL | Combination therapy SC single dose |
| Placebo SC Dose | EXPERIMENTAL | Matching placebo SC single dose |
| On Low-Flow Oxygen | EXPERIMENTAL | Cohort 1 (C1): O2 saturation \>93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device |
| With COVID-19 symptoms but not requiring supplemental O2 | EXPERIMENTAL | Cohort 1A (C1A): With COVID-19 symptoms but not requiring supplemental oxygen |
| High O2 No Mechanical Ventilation | EXPERIMENTAL | Cohort 2 (C2): On high-intensity oxygen (O2) therapy but not on mechanical ventilation |
| On Mechanical Ventilation | EXPERIMENTAL | Cohort 3 (C3): On mechanical ventilation |
| Name | Type | Description |
|---|---|---|
| REGN10933+REGN10987 combination therapy | DRUG | Administered IV or SC single dose |
| Placebo | DRUG | Administered IV or SC single dose to match |
Key Inclusion Criteria: * Has SARS-CoV-2-positive diagnostic test from a sample collected ≤72 hours prior to randomization, as defined by the protocol * Low-risk symptomatic patient: Has symptoms consistent with COVID-19 (as determined by the investigator) with onset ≤7 days before randomization, a...
REGN10933+REGN10987 is an investigational combination of two monoclonal antibodies being studied for the prevention and treatment of COVID-19. It has been evaluated in clinical trials for hospitalized adult patients with COVID-19, for prevention of SARS-CoV-2 infection in healthy adults and adolescents who are household contacts of infected individuals, and in healthy adult volunteers.
REGN10933+REGN10987 targets the spike (S) protein of SARS-CoV-2, the virus that causes COVID-19. The combination consists of two anti-spike monoclonal antibodies designed to bind to the spike protein and potentially neutralize the virus.
REGN10933+REGN10987 is being developed by Regeneron Pharmaceuticals, Inc., a biopharmaceutical company traded on the Nasdaq under the ticker symbol REGN. The company has conducted multiple clinical trials to evaluate the safety and efficacy of this antibody combination for COVID-19.
REGN10933+REGN10987 has completed Phase 1, Phase 2, and Phase 3 clinical trials. The trials include a Phase 3 study for prevention of SARS-CoV-2 infection in healthy adults and adolescents, and a Phase 1/2/3 study for hospitalized adult patients with COVID-19. All trials are completed.
REGN10933+REGN10987 has been studied in four completed clinical trials. NCT04426695 evaluated its efficacy in hospitalized adults with COVID-19. NCT04452318 assessed its efficacy for prevention of SARS-CoV-2 infection in healthy household contacts. NCT04519437 studied safety, tolerability, and pharmacokinetics in healthy volunteers. NCT04666441 evaluated virologic efficacy in adult outpatients with SARS-CoV-2 infection.
REGN10933+REGN10987 is a combination of two monoclonal antibodies, REGN10933 and REGN10987, administered together. The combination is sometimes referred to by the individual component names, but in clinical trials it is studied as a fixed combination product.