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Presatovir

Phase 2

Respiratory Syncytial Virus (RSV) | Small molecule | Infectious Disease |Gilead Sciences, Inc.|Last Updated: Nov 28, 2018

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 Trials1
Total Enrollment61
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT02534350Presatovir in Lung Transplant (LT) Recipients With Respiratory Syncytial Virus (RSV) InfectionPHASE2 COMPLETED 61 — — Dec 31, 2015Sep 27, 2017Nov 28, 201828 United States, Australia +6
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Study Endpoints
Primary Endpoints
Time-Weighted Average Change in Viral Load From Day 1/Baseline Through Day 7 in Participants in the Full Analysis Set
Up to 7 days
Time-Weighted Average Change in Viral Load From Day 1/Baseline Through Day 7 in a Subset of Participants in the Full Analysis Set Whose Duration of RSV Symptoms Prior to the First Dose of Study Drug is ≤ Median
Up to 7 days
Secondary Endpoints
Time-Weighted Average Change in FLU-PRO Score From Day 1/Baseline Through Day 7
Up to 7 days
Percent Change From Study Baseline in FEV1% Predicted Value
Baseline; Day 28
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
PresatovirEXPERIMENTALPresatovir 200 mg (4 x 50 mg) on Day 1, followed by 100 mg (2 x 50 mg) from Day 2 to Day 14
PlaceboPLACEBO_COMPARATORPlacebo tablets for a total of 14 days
Interventions
NameTypeDescription
PresatovirDRUGTablets administered orally or via nasogastric (NG) tube once daily
PlaceboDRUGTablets administered orally or via NG tube once daily
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites28

Key Inclusion Criteria: * Males and females ≥18 years of age who have received a LT (single or double) or heart/lung transplant \> 90 days prior to Screening * Confirmed to be RSV-positive by local polymerase chain reaction (PCR) testing (starting from when the upper or lower respiratory tract samp...

Countries:United StatesAustraliaBelgiumCanadaFranceGermanyNetherlandsUnited Kingdom
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