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LY3819253

Phase 2

COVID-19 | Small molecule | Infectious Disease |Eli Lilly and Company|Last Updated: Apr 11, 2024

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLEDDMCBiomarker
Total Trials2
Total Enrollment3,333
FDA Designations
No designations recorded
Clinical Trials (2)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT04427501A Study of LY3819253 (LY-CoV555) and LY3832479 (LY-CoV016) in Participants With Mild to Moderate COVID-19 IllnessPHASE2 COMPLETED 3,307Jun 17, 2020Feb 21, 2023Apr 11, 202412 United States
NCT04411628A Study of LY3819253 (LY-CoV555) in Participants Hospitalized for COVID-19PHASE1 COMPLETED 26May 28, 2020Aug 26, 2020Nov 12, 202111 United States
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Study Endpoints
Primary Endpoints
Phase 3: Percentage of Participants Who Experience COVID-Related Hospitalization or Death From Any Cause in 2800 mg Bamlanivumab/2800 mg Etesevimab, 700 mg Bamlanivimab/1400mg Etesevimab and Their Placebo Groups
Baseline through Day 29

COVID-19 Related Deterioration (yes/no) was defined as a participant experiencing COVID-19-related hospitalization (defined as 24 hours of acute care) or death from any cause by Day 29.

Phase 3: Percentage of Participants With SARS-CoV-2 Viral Load Greater Than a Prespecified Threshold in Arms 350 mg Bamlanivimab/700 mg Etesevimab and Placebo
Day 7

SARS-CoV-2 persistent high viral load (yes/no) was defined as ribonuclease P(RP) normalized viral load \>=5.27 vs otherwise.

Phase 2: Change From Baseline to Day 11 in Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Viral Load
Baseline, Day 11

SARS-CoV-2 viral load was based on nasopharyngeal swab sampling for reverse transcription polymerase chain reaction (RT-PCR) testing for SARS-CoV-2. Least squares (LS) mean values were determined using a mixed-effects model repeated-measures (MMRM) that included log base 10 transformed baseline as a covariate, treatment, day, treatment-by-day interaction as fixed effects. If Day 11 SARS-CoV-2 viral load was missing, the earliest measurement closest to the Day 11 visit, but within 4 days (Day 7-Day 15), was used for the Day 11 value. If no measurements were available, the Day 11 viral load was treated as missing at random (MAR) in the analysis. Viral load is reported as normalized viral load and is unitless.

Phase 2: Percentage of Participants Who Experience a Serious Adverse Event(s) SAE(s)
Baseline through Day 85

An SAE was defined as any untoward medical occurrence that, at any dose: results in death, is life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/birth defect and other different situations will have medical or scientific judgment to determine if they are SAE. A summary of SAEs and other non-serious adverse events (AEs), regardless of causality are reported in the Adverse Events section.

Phase 3 and Phase 2/3 [Arm 22], Pharmacokinetics (PK): Mean Concentrations of LY3819253 (Bamlanivimab)
Day 29 Post-dose

Mean Concentration of Bamlanivimab in the presence of Etesevimab is reported. Due to the limited number of pediatric participants across all study arms in phase 3, PK concentration summary data was combined including phase 3 and phase 2/3 (Pediatric addendum, Arm 22) reporting arms. All pediatric participants from Phase 3 trial arms including Arm 22 who contributed data to the required outcome (PK concentration at Day 29) were included in the PK summary.

Phase 3 and Phase 2/3 [Arm 22], Pharmacokinetics (PK): Mean Concentrations of LY3832479 (Etesevimab)
Day 29 Post-dose

Mean Concentration of Etesevimab in the presence of Bamlanivimab is reported. Due to the limited number of pediatric participants across all study arms in phase 3, PK concentration summary data was combined including phase 3 and phase 2/3 (Pediatric addendum, Arm 22) reporting arms. All pediatric participants from Phase 3 trial arms including Arm 22 who contributed data to the required outcome (PK concentration at Day 29) were included in the PK summary.

Phase 2/3, PK: Area Under the Concentration-time Curve From Time 0 to Infinity (AUC0-∞) for Bebtelovimab [Arm 23]
Day 60 Post-dose

AUC0-∞ for Bebtelovimab was reported.

Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration
Baseline through Day 60

An SAE is any adverse event that results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. The number of participants with 1 or more SAEs considered by the investigator to be related to study drug administration is reported. A summary of SAEs and other non-serious adverse events (AEs), regardless of causality, were reported in the Reported Adverse Events module.

Secondary Endpoints
Phase 3: Percentage of Participants Demonstrating Symptom Resolution
Day 11
Phase 3: Percentage of Participants Demonstrating Symptom Improvement
Day 11
Phase 3: Percentage of Participants Who Experience COVID-Related Hospitalization, COVID-Related Emergency Room (ER) Visit, or Death From Any Cause
Baseline through Day 85
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelSEQUENTIAL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
LY3819253EXPERIMENTAL700 mg, 2800 mg, 7000 mg, LY3819253 administered intravenously (IV)
LY3819253 + LY3832479EXPERIMENTAL350 mg, 700 mg, 2800 mg LY3819253 + 700 mg, 1400 mg, 2800 mg LY3832479 administered IV or subcutaneously (SQ)
LY3819253 + LY3832479 (Pediatric Addendum, Arm 22)EXPERIMENTALLY3819253 dose based upon weight (weight Group: ≥40 kilogram (kg) = 700 mg dose, \>20 kg to \<40 kg = 350 mg dose, \>12 kg to 20 kg = 175 mg dose and 1.5 kg to 12 kg = 15 mg/kg dose) and LY3832479 dose based upon weight (weight Group: ≥40 kg = 1400 mg dose, \>20 kg to \<40 kg = 700 mg dose, \>12 kg to 20 kg = 350 mg dose and 1.5 kg to 12 kg = 30 mg/kg dose) administered IV.
LY3853113 (Pediatric Addendum, Arm 23)EXPERIMENTALLY3853113 dose based upon weight (Weight Group: ≥3.3 to ≤12 kg = 3 mg/kg dose, \>12 to ≤20 kg = 43.75 mg dose, \>20 to \<40 kg = 87.5 mg dose, ≥40 kg = 175 mg dose) administered IV.
PlaceboPLACEBO_COMPARATORPlacebo administered IV
Interventions
NameTypeDescription
LY3819253DRUGAdministered IV
LY3832479DRUGAdministered IV
LY3853113DRUGAdministered IV
PlaceboDRUGAdministered IV
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Eligibility Criteria
Age Range0 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites12

Inclusion Criteria: * Are currently not hospitalized. (Not applicable to participants in treatment arm 22.) * Have one or more mild or moderate COVID-19 symptoms: Fever, cough, sore throat, malaise, headache, muscle pain, gastrointestinal symptoms, or shortness of breath with exertion. (Not applica...

Countries:United States
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