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Also known as VYD2311-SD, VYD2311-MD
VYD2311 · 3 trials · 1 indication
To compare the systemic reaction of VYD2311 (study drug) with a COVID-19 vaccine when administered alone or concurrently in healthy adults. E-diaries will solicit participant reported systemic reactions including vomiting, fever, diarrhea, headache, fatigue, chills, myalgia, and arthralgia.
| Arm | Type | Description |
|---|---|---|
| Treatment Arm 1: A COVID-19 vaccine and Placebo administered as 2 separate IM injections | ACTIVE_COMPARATOR | Treatment Arm 1: A COVID-19 vaccine administered by IM injection and placebo administered by IM injection in separate locations |
| Treatment Arm 2: VYD2311 and Placebo administered as 2 separate IM injections | ACTIVE_COMPARATOR | Treatment Arm 2: VYD2311 250 mg administered by IM injection and placebo administered by IM injection in separate locations |
| Treatment Arm 3: VYD2311 and COVID-19 vaccine administered as 2 separate IM injections | ACTIVE_COMPARATOR | Treatment Arm 3: VYD2311 250 mg and a COVID-19 vaccine adminstered as two IM injections in separate locations |
| VYD2311-SD (single dose) | ACTIVE_COMPARATOR | VYD2311 administered via IM injection on Day 1, followed by placebo injection (0.9% sodium chloride \[normal saline\]) on Day 30 and Day 60 |
| VYD2311-MD (multidose) | ACTIVE_COMPARATOR | VYD2311 administered via IM injection on Day 1, Day 30, and Day 60 |
| Placebo | PLACEBO_COMPARATOR | Normal saline administered by IM injection on Day 1, Day 30, and Day 60 |
| VYD2311 | EXPERIMENTAL | Injection in healthy volunteer |
| Name | Type | Description |
|---|---|---|
| COVID-19 mRNA vaccine | DRUG | A one-time dose of COVID-19 mRNA vaccine will be administered by intramuscular injection. |
| VYD2311 | DRUG | A one-time dose of VYD2311 250mg will be administered by intramuscular injection. |
| Placebo (Normal Saline) | DRUG | A one-time dose of normal saline (placebo) administered by intramuscular injection. |
| VYD2311-SD | DRUG | VYD2311-SD (single-dose arm): Intramuscular injection dosing on Day 1 with VYD2311 and Intramuscular injection dosing Placebo (normal saline) on Day 30 and Day 60 |
| VYD2311-MD | DRUG | VYD2311-MD (multi-dose): Intramuscular injection dosing on Day 1, Day 30, and Day 60 with VYD2311 |
| Placebo | DRUG | Intramuscular injection dosing on Day 1, Day 30, and Day 60 with Placebo (Normal Saline) |
Inclusion Criteria: 1. Is a healthy adult male or female aged 18 to 49 years, inclusive, weighing at least 40 kg at the time of Screening 2. Has a body mass index (BMI) 18.0 to 32.0 mg/kg2, inclusive. 3. Is in good health, with no clinically significant abnormalities as determined by the Investigat...
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 |
VYD2311 is an investigational monoclonal antibody developed by Invivyd, Inc. for the prevention of COVID-19. It is being studied in clinical trials and has received FDA Fast Track designation. VYD2311 is not yet approved and remains in late-stage development, with a Biologics License Application stage reached.
VYD2311 targets SARS-CoV-2, the virus that causes COVID-19. As a monoclonal antibody, it is designed to bind the virus and provide serum virus neutralizing antibody responses. It is being evaluated both as a standalone preventive agent and coadministered with a COVID-19 vaccine.
VYD2311 is developed by Invivyd, Inc., which trades under the ticker IVVD. Invivyd is the sponsor of the clinical program studying VYD2311 for COVID-19 prevention, including Phase 1 and Phase 3 trials conducted in the United States and Australia.
VYD2311 is in the NDA/BLA stage of development, meaning the program has advanced to the regulatory submission phase. It is investigational and has not been approved. The clinical program includes Phase 1 and Phase 3 trials, with one completed and two active but not recruiting.
VYD2311 has been studied in three trials. NCT07655180 is a completed Phase 3 study of VYD2311 and coadministration with a COVID-19 vaccine in 210 participants. NCT07298434 is an active Phase 3 prevention study in 1,770 participants. NCT06523153 is a Phase 1 study in 40 healthy participants in Australia.
Yes, VYD2311-SD and VYD2311-MD are alternative names for VYD2311, the investigational monoclonal antibody developed by Invivyd, Inc. for COVID-19 prevention. Searches for any of these names refer to the same drug asset and the same clinical development program.