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AT-752

Phase 1

Dengue | Small molecule | Infectious Disease |Atea Pharmaceuticals, Inc.|Last Updated: Oct 17, 2022

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_CONTROLLEDBiomarker
Total Trials1
Total Enrollment65
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT04722627Study of AT-752 in Healthy SubjectsPHASE1 COMPLETED 65 — — Mar 9, 2021Nov 14, 2021Oct 17, 20221 Australia
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Study Endpoints
Primary Endpoints
Proportions (active vs. Placebo) of subjects experiencing treatment-emergent adverse events
Day 6 for single dose or Day 12 for multiple dose
Pharmacokinetics (PK) of AT-752 of single and multiple ascending oral doses
Day 1 for subjects receiving a single fasted dose; Days 1 and 7 for subjects receiving multiple doses

Maximum plasma concentration (Cmax)

Effect of food on Pharmacokinetics (PK) of AT-752 of a single oral dose
Day 1 for subjects receiving a single fed dose]

Maximum plasma concentration (Cmax)

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Study Design & Arms
AllocationRANDOMIZED
MaskingTRIPLE
ModelSEQUENTIAL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
AT-752 250 mg single doseEXPERIMENTALAT-752 administered orally, 250 mg on Day 1
Placebo -single dosePLACEBO_COMPARATORMatching placebo administered orally on Day 1
AT-752 500 mg single doseEXPERIMENTALAT-752 administered orally, 500 mg single doses on Day 1 and Day 7
Placebo- single dosePLACEBO_COMPARATORMatching placebo administered orally on Day 1 and Day 7
AT-752 1000 mg single doseEXPERIMENTALAT-752 administered orally, 1000 mg single dose on Day 1
Placebo - single dosePLACEBO_COMPARATORMatching placebo administered orally on Day 1
AT-752 1500 mg single doseEXPERIMENTALAT-752 administered orally, 1500 mg single dose on Day 1
Placebo: single dosePLACEBO_COMPARATORMatching placebo administered orally on Day 1
AT-752 - 1000 mg QD multiple dosesEXPERIMENTALAT-752 - administered orally, 1000 mg once daily (QD) for 7 days
Placebo - Administered once daily (QD)PLACEBO_COMPARATORMatching placebo administered orally once daily (QD) for 7 days
AT-752 - 750 mg twice daily (BID)EXPERIMENTALAT-752 administered orally, 750 mg twice daily (BID) for 4 days plus one dose on Day 5.
Placebo - Administered twice daily (BID)PLACEBO_COMPARATORMatching placebo administered orally twice daily (BID) for 4 days plus one dose on Day 5.
AT-752 - 750 mg three times daily (TID)EXPERIMENTALAT-752 administered orally, 750 mg three times daily (TID) for 4 days plus one dose on Day 5.
Placebo - Administered TIDPLACEBO_COMPARATORMatching placebo administered orally (TID) for 4 days plus one dose on Day 5.
Interventions
NameTypeDescription
AT-752DRUGParallel Assignment
PlaceboDRUGParallel Assignment
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Eligibility Criteria
Age Range18 Years — 65 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: 1. Body mass index (BMI) of 18-29 kg/m2 2. Must agree to use protocol-specified methods of contraception 3. Negative pregnancy test 4. Willing to comply with the study requirements and to provide written informed consent Exclusion Criteria: 1. Pregnant or breastfeeding 2. Abus...

Countries:Australia
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Competitive Landscape -Dengue 10 trials
CompanyTickerTrialsLead PhaseDrugs
Takeda Pharmaceutical Co. Ltd. Sponsored ADRTAK5PHASE3Tetravalent Dengue Vaccine, TDV
Novartis AG Sponsored ADRNVS1PHASE2EYU688
Sanofi SA Sponsored ADRSNY1 — Undisclosed
Abbott LaboratoriesABT1 — Undisclosed
Danaher CorporationDHR1 — Undisclosed
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