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Bemnifosbuvir

Phase 3

Severe Acute Respiratory Syndrome Coronavirus 2 (SARS CoV 2 Infection) | Small molecule | Infectious Disease |Atea Pharmaceuticals, Inc.|Last Updated: Jun 13, 2025

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 Enrollment2,285
FDA Designations
FAST_TRACK
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT05629962SUNRISE-3: Efficacy and Safety of Bemnifosbuvir in High-Risk Outpatients With COVID-19PHASE3 COMPLETED 2,285Nov 25, 2022May 30, 2024Jun 13, 2025263 United States, Argentina +17
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Study Endpoints
Primary Endpoints
Percentage of Subjects Hospitalized for Any Cause or Died Due to Any Cause
Day 1 through Day 29
Secondary Endpoints
Percentage of Subjects Hospitalized Due to COVID-19 or Died Due to Any Cause
Day 1 through Day 29
Percentage of Subjects Who Died Due to Any Cause
Day 1 through Day 29; Day 1 through Day 60
Percentage of Subjects With COVID-19-related Complications
Day 1 through Day 29
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Study Design & Arms
AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Bemnifosbuvir (BEM)EXPERIMENTAL -
PlaceboPLACEBO_COMPARATOR -
Interventions
NameTypeDescription
Bemnifosbuvir (BEM)DRUGBEM tablets administered orally every 12 hours (twice a day) for a total of 5 days
PlaceboDRUGPlacebo tablets administered orally every 12 hours (twice a day) for a total of 5 days
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites263

Inclusion Criteria: * Positive SARS-CoV-2 test conducted ≤ 5 days prior to randomization * Mild or moderate COVID-19 with symptom onset ≤ 5 days before randomization and at least one COVID-19 related symptom present at time of screening * Subject must be high risk, defined below: 1. Age ≥70 year...

Countries:United StatesArgentinaBrazilCanadaGermanyIndiaJapanLatviaMexicoNetherlandsPakistanPhilippinesRomaniaSouth AfricaSpainSwedenTunisiaTurkey (Türkiye)United Kingdom
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