Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as REGN-COV2, REGEN-COV™, Ronapreve™, casirivimab, imdevimab
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...
Top 9 of 11 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Pfizer Inc. | PFE | 7 | PHASE3 | ibuzatrelvir, Nirmatrelvir/ ritonavir, BNT162b2/RIV |
| Merck & Co., Inc. | MRK | 2 | PHASE3 | Molnupiravir |
| Invivyd, Inc. | IVVD | 2 | PHASE3 | VYD2311 |
| Vanda Pharmaceuticals Inc. | VNDA | 1 | PHASE3 | Tradipitant |
| Moderna, Inc. | MRNA | 2 | PHASE2 | mRNA-1283, mRNA-1273 |
| ImmunityBio Inc | IBRX | 2 | PHASE2 | Nogapendekin alfa inbakicept |
| Traws Pharma, Inc. | TRAW | 1 | PHASE2 | Ratutrelvir |
| GeoVax Labs, Inc. | GOVX | 1 | PHASE2 | GEO-CM04S1 |
| Gilead Sciences, Inc. | GILD | 1 | PHASE2 | Remdesivir |
REGN10933+REGN10987 is an investigational combination therapy developed by Regeneron Pharmaceuticals for COVID-19, the disease caused by SARS-CoV-2 infection. It combines two monoclonal antibodies and has been studied in adult patients, including outpatients and hospitalized patients, across two completed clinical trials with a total enrollment of 3,401 participants.
REGN10933+REGN10987 was studied for the treatment of COVID-19 in adults with SARS-CoV-2 infection. Clinical testing covered both adult outpatients and hospitalized adult patients. The program includes two completed trials, one Phase 2 study in outpatients and one Phase 1 study in hospitalized patients.
Regeneron Pharmaceuticals, Inc. develops REGN10933+REGN10987. Regeneron trades on the Nasdaq under the ticker REGN. The company sponsored both clinical trials of the combination in COVID-19, one evaluating virologic efficacy across dose regimens in outpatients and one assessing safety and efficacy in hospitalized patients.
REGN10933+REGN10987 is in Phase 2 development for COVID-19. Both of its clinical trials are completed, and no trials are currently active. The Phase 2 study evaluated virologic efficacy across different dose regimens in adult outpatients, while an earlier Phase 1 study enrolled hospitalized adult patients.
REGN10933+REGN10987 has been evaluated in two completed trials. NCT04666441 was a Phase 2 study of virologic efficacy across different dose regimens in adult outpatients with SARS-CoV-2 infection, enrolling 1,149 participants in the United States. NCT04426695 was a Phase 1 safety, tolerability, and efficacy study in 2,252 hospitalized adult patients across the United States, Brazil, Chile, Mexico, Moldova, and Romania.