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VXCO-100

Phase 1

SARS-CoV | Monoclonal antibody | Infectious Disease |Eli Lilly and Company|Last Updated: Dec 10, 2024

Development status

Highest phase Phase 1
Registered trials 2 across 1 sponsor since May 2023

Success Probability

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Market & Valuation

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Trial Design

RandomizedCONTROLLEDDMC
Total Trials2
Total Enrollment251

FDA Designations

No designations recorded

Clinical trial landscape

VXCO-100 · 2 trials · 2 indications

Phase 1 2
NCT05938075Study of VXCO-100, a SARS-CoV Candidate Vaccine, in Adults in the Republic of South AfricaSARS-CoV
COMPLETED130 Analytics
NCT05870839Study of VXCO-100, a SARS-CoV Candidate Vaccine in Healthy Adults in the United StatesSARS-CoV
COMPLETED121 Analytics
PHASE1COMPLETED
Study of VXCO-100, a SARS-CoV Candidate Vaccine, in Adults in the Republic of South Africa
SARS-CoVUnlock trial analytics
PHASE1COMPLETED
Study of VXCO-100, a SARS-CoV Candidate Vaccine in Healthy Adults in the United States
SARS-CoVUnlock trial analytics

Study Endpoints

Primary Endpoints

Number and percentage of participants with solicited local adverse events
For 7 days after each product administration
Number and percentage of participants with solicited systemic adverse events
For 7 days after each product administration
Number and percentage of participants with unsolicited and safety laboratory-based adverse events
For 28 days after each product administration
Numbers and percentages of participants with serious adverse events (SAEs) including suspected unexpected serious adverse reactions (SUSARs), medically attended adverse events (MAAEs), and adverse events of special interest (AESIs)
For 364 days after each product administration

Secondary Endpoints

Response rate measured by geometric mean titer of the serum neutralizing antibody (Nab) against the ancestral (Wuhan) strain
At baseline and 21 days after each product administration
Response rate measured by GMT of Nab against selected variants of concern
At baseline and 21 days after each product administration
Numbers and percentages of participants with positive Th1 or Th2 cytokine responses for CD4 and CD8 as measured by multi-parameter intracellular cytokine staining
At baseline and 7 days after each product administration
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelSEQUENTIAL
PurposePREVENTION

Treatment Arms

ArmTypeDescription
VXC0-100 at Dose level 1EXPERIMENTALParticipants will receive VXCO-100 at Dose Level 1 via intramuscular (IM) injection on Day 1 and then an optional boost of VXCO-100 at Dose Level 1 on Month 6.
VXC0-100 at Dose level 2EXPERIMENTALParticipants will receive VXCO-100 at Dose Level 2 via intramuscular (IM) injection on Day 1 and then an optional boost of VXCO-100 at Dose Level 2 on Month 6.
VXC0-100 at Dose level 3EXPERIMENTALParticipants will receive VXCO-100 at Dose Level 3 via intramuscular (IM) injection on Day 1 and then an optional boost of VXCO-100 at Dose Level 3 on Month 6.
COVID-19 mRNA vaccineEXPERIMENTALParticipants will receive a COVID-19 mRNA vaccine on Day 1 and then a boost with the same COVID-19 mRNA vaccine at Day 21.
VXCO-100 Group 1EXPERIMENTALParticipants 18-55 years of age will receive VXCO-100 at Dose Level 1 via intramuscular (IM) injection
VXCO-100 Group 2EXPERIMENTALParticipants 18-55 years of age will receive VXCO-100 at Dose Level 2 via intramuscular (IM) injection
VXCO-100 Group 3EXPERIMENTALParticipants 18-55 years of age will receive VXCO-100 at Dose Level 3 via intramuscular (IM) injection
VXCO-100 Group 4EXPERIMENTALParticipants 56+ years of age will receive VXCO-100 at Dose Level 1 via intramuscular (IM) injection
VXCO-100 Group 5EXPERIMENTALParticipants 56+ years of age will receive VXCO-100 at Dose Level 2 via intramuscular (IM) injection
VXCO-100 Group 6EXPERIMENTALParticipants 56+ years of age will receive VXCO-100 at Dose Level 3 via intramuscular (IM) injection

Interventions

NameTypeDescription
VXCO-100BIOLOGICALSterile suspension for injection
COVID-19 mRNA vaccineBIOLOGICALSterile suspension for injection
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersYes
Study Sites2

Inclusion Criteria: A participant must meet all the following criteria to be eligible for the study: 1. Adults ages 18 years and older 2. Judged by the investigator to be healthy based on participant-reported medical history, physical examination, vital signs, and laboratory assessment. 3. Able to...

Countries:South AfricaUnited States
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Frequently asked questions about VXCO-100

What is VXCO-100?

VXCO-100 is an investigational monoclonal antibody developed by Eli Lilly and Company for SARS-CoV, the virus that causes COVID-19. It is in Phase 1 clinical development and has been studied in healthy adult volunteers. Both of its Phase 1 trials have been completed.

What is VXCO-100 used for?

VXCO-100 is being developed for SARS-CoV and SARS-CoV-2, the coronaviruses responsible for COVID-19. Its clinical program has focused on healthy adult volunteers rather than patients with active disease. It remains investigational and is not an approved product.

Who makes VXCO-100?

VXCO-100 is developed by Eli Lilly and Company, which trades on the New York Stock Exchange under the ticker LLY. Lilly sponsored both Phase 1 trials of the candidate, one conducted in the United States and one in the Republic of South Africa.

What phase is VXCO-100 in?

VXCO-100 is in Phase 1 clinical development. Both of its Phase 1 trials are listed as completed, and no trials are currently active. It is an investigational monoclonal antibody and has not been approved by the FDA for any indication.

What clinical trials is VXCO-100 in?

VXCO-100 has been evaluated in two completed Phase 1 trials. NCT05870839 enrolled 121 healthy adults in the United States, and NCT05938075 enrolled 130 adults in the Republic of South Africa. Together the two randomized, controlled studies enrolled 251 participants aged 18 years and older.

How does VXCO-100 work?

VXCO-100 is a monoclonal antibody directed against SARS-CoV. Monoclonal antibodies are designed to bind a specific viral target, and this candidate was studied as a SARS-CoV vaccine approach in healthy adult volunteers. Detailed target and mechanism information has not been publicly characterized beyond its monoclonal antibody modality.