Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
VYD222 · 2 trials · 2 indications
| Arm | Type | Description |
|---|---|---|
| Cohort A VYD222 | EXPERIMENTAL | - |
| Cohort B VYD222 | EXPERIMENTAL | - |
| Cohort B Placebo | PLACEBO_COMPARATOR | - |
| Cohort 1 | EXPERIMENTAL | 10 total participants Cohort 1. 8 participants on VYD222 2 participants on placebo |
| Cohort 2 | EXPERIMENTAL | 10 total participants Cohort 2. 8 participants on VYD222 2 participants on placebo |
| Cohort 3 | EXPERIMENTAL | 10 total participants Cohort 3. 8 participants on VYD222 2 participants on placebo |
| Name | Type | Description |
|---|---|---|
| VYD222 (pemivibart) | DRUG | Participants will be dosed on Day 1 followed by redosing at Month 3 (approximately 90 days) with VYD222. |
| Normal saline | DRUG | Participants will be dosed on Day 1 followed by redosing at Month 3 (approximately 90 days) with Placebo. |
| VYD222 | DRUG | Monoclonal antibody |
| Placebo | OTHER | Matching Placebo |
Inclusion Criteria: * Is an adult aged ≥18 years or an adolescent aged 12 to \<18 years and weighs at least 40 kg at the time of Screening. * Tests negative for current SARS-CoV-2 infection by local antigen test or RT-PCR at the time of Screening. * For Cohort A, has significant immune compromise f...
VYD222 is an investigational monoclonal antibody being studied for the prevention of COVID-19 in adults with immune compromise and in participants aged 12 years or older who are at risk of exposure to SARS-CoV-2. It is also being studied for its safety, tolerability, and pharmacokinetics in healthy adult participants.
VYD222 is being developed by Invivyd, Inc., a biopharmaceutical company. The company is listed on the stock exchange under the ticker symbol IVVD.
VYD222 is in Phase 3 clinical development for the prevention of COVID-19. It has completed a Phase 1 study and a Phase 3 study, and it remains an investigational drug that has not been approved by regulatory authorities.
VYD222 has been studied in two completed clinical trials. The Phase 1 trial, NCT05791318, enrolled 30 healthy adults in Australia to evaluate safety, tolerability, and pharmacokinetics. The Phase 3 trial, NCT06039449, enrolled 790 participants in the United States to investigate prevention of COVID-19 in immunocompromised adults and at-risk individuals aged 12 years or older.
VYD222 is a distinct investigational monoclonal antibody developed by Invivyd, Inc. It is not known to be the same as any other approved or marketed drug. Its development is focused on preventing COVID-19 in vulnerable populations.