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MEDI8897

Phase 3

Respiratory Syncytial Virus Infections | Small molecule | Respiratory |AstraZeneca PLC|Last Updated: Feb 28, 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 Trials4
Total Enrollment5,732
FDA Designations
No designations recorded
Clinical Trials (4)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT03979313A Study to Evaluate the Safety and Efficacy of MEDI8897 for the Prevention of Medically Attended Lower Respiratory Tract Infection Due to Respiratory Syncytial Virus in Healthy Late Preterm and Term Infants (MELODY)PHASE3 COMPLETED 3,012Jul 23, 2019Mar 21, 2023Feb 28, 2024198 United States, Argentina +29
NCT03959488A Study to Evaluate the Safety of MEDI8897 for the Prevention of Medically Attended Respiratory Syncytial Virus(RSV) Lower Respiratory Track Infection (LRTI) in High-risk ChildrenPHASE2 COMPLETED 925Jul 30, 2019Jan 20, 2023Sep 21, 2023128 United States, Austria +24
NCT02878330A Study to Evaluate the Safety and Efficacy of MEDI8897 for the Prevention of Medically Attended RSV LRTI in Healthy Preterm Infants.PHASE2 COMPLETED 1,453Nov 3, 2016Dec 6, 2018Oct 14, 2019161 United States, Argentina +21
NCT02114268A Phase 1 Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of MEDI8897 in Healthy AdultsPHASE1 COMPLETED 342Apr 1, 2014Jun 1, 2015Nov 28, 20161 United States
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Study Endpoints
Primary Endpoints
Number of Participants With MA RSV LRTI Through 150 Days Post Dose (Primary Cohort)
Through 150 Days Post Dose

Primary Endpoint Analysed on Primary Cohort Through 150 Days (N=1490 Participants)

Safety and Tolerability of MEDI8897 as Assessed by the Occurrence of All Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs) and Adverse Events of Special Interest (AESIs) and New Onset Chronic Disease (NOCD)
360 days post first dose

Safety and tolerability of MEDI8897 will be assessed by the occurrence of all treatment-emergent adverse events (TEAEs), treatment-emergent serious adverse events (TESAEs) , adverse events of special interest (AESIs), and new onset chronic diseases (NOCDs)

Number of Participants With Medically Attended Respiratory Syncytial Virus (RSV) Confirmed Lower Respiratory Tract Infection (LRTI)
From Day 1 through Day 151

The determination of medically attended RSV LRTI is based on objective clinical LRTI criteria and RSV test results obtained from analyzing the respiratory secretions using a validated RSV real time reverse transcriptase-polymerase chain reaction (RT-PCR) assay for the detection of RSV A or RSV B subtypes. Criteria for LRTI included documented physical exam findings of rhonchi, rales, crackles, or wheeze and any of the following: increased respiratory rate at rest (for age less than (\<) 2 months: greater than or equal to (\>=) 60 breaths/min; 2-6 months: \>= 50 breaths/min; and for \> 6 months - 2 years, \>= 40 breaths/min), or hypoxemia (in room air - oxygen saturation \< 95% at altitudes less than or equal to (\<=) 1800 meters or \< 92% at altitudes \> 1800 meters), or clinical signs of severe respiratory disease or dehydration secondary to inadequate oral intake due to respiratory distress (need for intravenous fluid).

Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)
From start of study drug administration up to Day 391 (Day 361 +/- 30 days)

An adverse event (AE) is defined as events present at baseline that worsened in intensity after administration of investigational products or events absent at baseline that emerged after administration of study drug, for the period extending to 391 (Day 361 ± 30 days) days after the last dose of study drug.

Secondary Endpoints
Number of Participants With MA RSV LRTI With Hospitalisation Through 150 Days Post Dose (Primary Cohort)
Through 150 Days Post Dose
Summary of Serum Concentrations (ug/mL) of MEDI8897 by Group
By visit until day 360 post dose
Anti-drug Antibody Results by Visit (As Treated Population)
From baseline to 360 day post dose visit
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposePREVENTION
Treatment Arms
ArmTypeDescription
MEDI8897EXPERIMENTALAnti-RSV monoclonal antibody with an extended half-life
PlaceboPLACEBO_COMPARATORCommercially available 0.9% (w/v) saline
PalivizumabACTIVE_COMPARATORanti-RSV monoclonal antibody
MEDI8897 50 mgEXPERIMENTALParticipants will receive a single IM dose of MEDI8897 50 milligrams (mg) on Day 1 of the study.
MEDI8897 300 milligram (mg) Intravenous (IV)EXPERIMENTALParticipants received a single fixed dose of 300 mg MEDI8897 intravenous infusion on Day 1.
MEDI8897 1000 mg IVEXPERIMENTALParticipants received a single fixed dose of 1000 mg MEDI8897 intravenous infusion on Day 1.
MEDI8897 3000 mg IVEXPERIMENTALParticipants received a single fixed dose of 3000 mg MEDI8897 intravenous infusion on Day 1.
MEDI8897 100 mg Intramuscular (IM)EXPERIMENTALParticipants received a single fixed dose of 100 mg MEDI8897 intramuscular injection on Day 1.
MEDI8897 300 mg IMEXPERIMENTALParticipants received a single fixed dose of 300 mg MEDI8897 intramuscular injection on Day 1.
Interventions
NameTypeDescription
MEDI8897DRUGAnti-RSV monoclonal antibody with an extended half-life
PlaceboDRUGCommercially available 0.9% (w/v) saline
PalivizumabDRUGApproved anti-RSV monoclonal antibody
MEDI8897 IntravenousDRUGParticipants received a single fixed dose of 300 mg MEDI8897 intravenous infusion on Day 1.
MEDI8897 IntramuscularDRUGParticipants received a single fixed dose of 100 mg MEDI8897 intramuscular injection on Day 1.
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Eligibility Criteria
Age Range0 Years — 1 Year
SexALL
Healthy VolunteersYes
Study Sites198

Key Inclusion Criteria: * Healthy infants in their first year of life and born at or after 35 weeks 0 days GA * Infants who are entering their first RSV season at the time of screening Key Exclusion Criteria: * Meets national or other local criteria to receive commercial palivizumab * Any fever (...

Countries:United StatesArgentinaAustraliaAustriaBelgiumBulgariaCanadaChileColombiaCzechiaEstoniaFinlandFranceGermanyIsraelItalyJapanLatviaLithuaniaMexicoNew ZealandPanamaPolandRussiaSouth AfricaSouth KoreaSpainSwedenTurkey (Türkiye)UkraineUnited KingdomHungaryBrazil
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