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VYD222

Phase 3

COVID-19 | Small molecule | Infectious Disease |Invivyd, Inc.|Trials Updated: Dec 9, 2024

VYD222 development status

Highest phase Phase 3
Registered trials 2 across 1 sponsor since Mar 2023

VYD222 target and mechanism

Molecular targetSARS-CoV-2
Target classVirus
ModalitySmall molecule

Also known as VYD222 (pemivibart)

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindCONTROLLEDDMC
Total Trials2
Total Enrollment820

FDA Designations

No designations recorded

VYD222 clinical trials

VYD222 · 2 trials · 2 indications

Phase 3 1Phase 1 1
NCT06039449A Study to Investigate the Prevention of COVID-19 WithVYD222 in Adults with Immune Compromise and in Participants Aged 12 Years or Older Who Are At Risk of Exposure to SARS-CoV-2COVID-19
COMPLETED790 Analytics
PHASE3COMPLETED
A Study to Investigate the Prevention of COVID-19 WithVYD222 in Adults with Immune Compromise and in Participants Aged 12 Years or Older Who Are At Risk of Exposure to SARS-CoV-2
COVID-19Unlock trial analytics

Study Endpoints

Primary Endpoints

Cohort A - Incidence of treatment emergent adverse events
Through Month 12
Cohort A - Ratio of SARS-CoV-2 sVNA titer against a relevant variant following VYD222 administration at Day 28 compared to a prespecified SARS-CoV-2 sVNA titer threshold.
Day 28
Cohort B - Incidence of treatment emergent adverse events
Through Month 12
Incidence of TEAEs (including AEs and SAEs)
Through 12 Months

Secondary Endpoints

Cohort A - Proportion of participants with sVNA titer against a relevant variant following VYD222 administration at Day 28 above a prespecified SARS-CoV-2 sVNA titer threshold.
Day 28
Cohort A - sVNA titer by timepoint following VYD222 administration
Through Month 12
Cohort A - Proportion of participants with sVNA titer against a relevant variant following VYD222 administration above a minimum SARS-CoV-2 sVNA threshold by timepoint
Through Month 12
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposePREVENTION

Treatment Arms

ArmTypeDescription
Cohort A VYD222EXPERIMENTAL -
Cohort B VYD222EXPERIMENTAL -
Cohort B PlaceboPLACEBO_COMPARATOR -
Cohort 1EXPERIMENTAL10 total participants Cohort 1. 8 participants on VYD222 2 participants on placebo
Cohort 2EXPERIMENTAL10 total participants Cohort 2. 8 participants on VYD222 2 participants on placebo
Cohort 3EXPERIMENTAL10 total participants Cohort 3. 8 participants on VYD222 2 participants on placebo

Interventions

NameTypeDescription
VYD222 (pemivibart)DRUGParticipants will be dosed on Day 1 followed by redosing at Month 3 (approximately 90 days) with VYD222.
Normal salineDRUGParticipants will be dosed on Day 1 followed by redosing at Month 3 (approximately 90 days) with Placebo.
VYD222DRUGMonoclonal antibody
PlaceboOTHERMatching Placebo
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Eligibility Criteria

Age Range12 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites18

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...

Countries:United StatesAustralia
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Frequently asked questions about VYD222

What is VYD222 used for?

VYD222 is being developed for the prevention of COVID-19 caused by SARS-CoV-2. It is intended for adults with immune compromise and for people aged 12 years or older who are at risk of exposure to SARS-CoV-2. It is an investigational product and has not been approved by the FDA.

What does VYD222 target?

VYD222 targets SARS-CoV-2, the virus that causes COVID-19. It is a monoclonal antibody designed to bind the virus, which places it in the antiviral antibody class of therapies. Its development focuses on preventing COVID-19 in people who are immune compromised or otherwise at risk of exposure.

Who is developing VYD222?

VYD222 is being developed by Invivyd, Inc., which trades on the Nasdaq under the ticker IVVD. Invivyd is the sponsor of the clinical program studying the antibody for prevention of COVID-19 in immune compromised and at-risk populations.

What phase is VYD222 in?

VYD222 has completed a Phase 3 clinical trial and a Phase 1 clinical trial. It is an investigational therapy and is not FDA approved. The Phase 3 study evaluated prevention of COVID-19, while the Phase 1 study assessed safety, tolerability, and pharmacokinetics in healthy adult participants.

What clinical trials is VYD222 in?

VYD222 has been studied in two completed trials. NCT06039449 was a Phase 3 trial of COVID-19 prevention in adults with immune compromise and participants aged 12 years or older at risk of SARS-CoV-2 exposure, enrolling 790 participants in the United States. NCT05791318 was a Phase 1 safety, tolerability, and pharmacokinetics study in 30 healthy adults in Australia.

Is VYD222 the same as pemivibart?

Yes. VYD222 is also known as pemivibart, so the two names refer to the same monoclonal antibody candidate. Searches for either name lead to the same Invivyd, Inc. development program for prevention of COVID-19 in immune compromised and at-risk populations.