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AT-527

Phase 2

Hepatitis C | Small molecule | Infectious Disease |Atea Pharmaceuticals, Inc.|Last Updated: May 4, 2020

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
CONTROLLEDBiomarker
Total Trials1
Total Enrollment10
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT04019717Study of AT-527 in Combination With Daclatasvir in Subjects With Hepatitis C Virus (HCV) InfectionPHASE2 COMPLETED 10Jun 20, 2019Mar 23, 2020May 4, 20203 Belgium, Mauritius +1
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Study Endpoints
Primary Endpoints
Proportion of subjects achieving sustained virologic response (SVR)
12 weeks after end of treatment

SVR defined as the HCV RNA \< lower limit of quantitation (LLOQ) at 12 weeks after end of treatment

Incidence of treatment-emergent adverse events
Through 4 weeks after end of treatment
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
8 weeksEXPERIMENTAL -
12 weeksEXPERIMENTAL -
Interventions
NameTypeDescription
AT-527DRUGNucleotide prodrug inhibitor of HCV nonstructural protein 5B (NS5B) polymerase
DaclatasvirDRUGInhibitor of HCV nonstructural protein 5A (NS5A)
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Eligibility Criteria
Age Range18 Years — 65 Years
SexALL
Healthy VolunteersNo
Study Sites3

Inclusion Criteria: * Body mass index (BMI) of 18-35 kg/m2 * Must agree to use protocol-specified methods of contraception * Negative pregnancy test * HCV genotype 1 * Documented history compatible with chronic hepatitis C * HCV RNA ≥ 10,000 IU/mL at Screening. * Willing to comply with the study re...

Countries:BelgiumMauritiusMoldova
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Competitive Landscape -Hepatitis C 11 trials