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ABI-1179

Phase 1

Recurrent Genital Herpes Simplex Type 2 | Small molecule | Infectious Disease |Assembly Biosciences, Inc.|Last Updated: Mar 23, 2026

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_CONTROLLED
Total Trials1
Total Enrollment103
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT06698575A Study to Assess the Safety, Pharmacokinetics, and Tolerability of ABI-1179 in Healthy Subjects and in Subjects Seropositive for HSV-2 With Recurrent Genital HerpesPHASE1 COMPLETED 103 — — Dec 8, 2024Jan 19, 2026Mar 23, 202618 United States, Australia +1
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Study Endpoints
Primary Endpoints
Area Under the Plasma Concentration Time Curve, (AUC) of ABI-1179
SAD Cohorts: before and at pre-specified timepoints up to 144 hours after dosing. MAD Cohorts: before and at pre-specified time points up to 8 hours after dosing.
Maximum Observed Plasma Concentration (Cmax) of ABI-1179
SAD Cohorts: before and at pre-specified timepoints up to 144 hours after dosing. MAD Cohorts: before and at pre-specified time points up to 8 hours after dosing.
Time to Cmax (Tmax) of ABI-1179
SAD Cohorts: before and at pre-specified timepoints up to 144 hours after dosing. MAD Cohorts: before and at pre-specified time points up to 8 hours after dosing.
Apparent Terminal Elimination Half Life ( t 1/2) ABI-1179
SAD Cohorts: before and at pre-specified timepoints up to 144 hours after dosing. MAD Cohorts: before and at pre-specified time points up to 8 hours after dosing.
Apparent Systemic Clearance (CL/F) of ABI-1179
SAD Cohorts: before and at pre-specified timepoints up to 144 hours after dosing. MAD Cohorts: before and at pre-specified time points up to 8 hours after dosing.
Apparent Volume of Distribution (Vz/F) of ABI-1179
SAD Cohorts: before and at pre-specified timepoints up to 144 hours after dosing. MAD Cohorts: before and at pre-specified time points up to 8 hours after dosing.
Dose normalized AUCs and Cmax of ABI-1179
SAD Cohorts: before and at pre-specified timepoints up to 144 hours after dosing. MAD Cohorts: before and at pre-specified time points up to 8 hours after dosing.
Proportion of subjects with adverse events (AEs), premature treatment discontinuation due to AE's and abnormal laboratory results.
Up to 56 days after last dose.
Secondary Endpoints
SAD Cohorts: Comparison of Plasma AUC between fasted and fed treatments
MAD Cohorts: At pre-specified time points from Days 8 to 36.
SAD Cohorts: Comparison of plasma Cmax between fasted and fed treatments
SAD Cohorts: before and at pre-specified timepoints up to 144 hours after dosing.
MAD Cohort: If applicable comparison of plasma AUC and Cmax with and without loading doses
MAD Cohorts At pre-specified timepoints from Days 8 to 36
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Study Design & Arms
AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Part A: SAD Cohorts 1-5, ABI-1179EXPERIMENTALSingle dose of ABI-1179 (tablet) in Part A for cohorts 1-5
Part A:SAD Cohorts 1-5, PlaceboPLACEBO_COMPARATORSingle dose of matching placebo (tablet) in Part A for Cohorts 1-5
Part A: (SAD) Fed Cohort 6 or 7, ABI-1179EXPERIMENTALSingle dose of ABI-1179 (tablet) in Part A for Cohort 6 or 7, food effect
Part B: MAD Cohorts 1-4, ABI-1179EXPERIMENTALWeekly dose ofABI-1179 (tablet) in Part B for Cohorts 1-4. May have loading dose.
Part B: MAD Cohorts 1-4 PlaceboPLACEBO_COMPARATORWeekly dose of matching placebo (tablet) in Part B for Cohorts 1-4.
Interventions
NameTypeDescription
ABI-1179DRUGOnce daily tablet dosing (SAD), or weekly tablet dosing over 29 days (MAD)
ABI-1179 PlaceboDRUGOnce daily tablet dosing (SAD), or weekly tablet dosing over 29 days (MAD)
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Eligibility Criteria
Age Range18 Years — 60 Years
SexALL
Healthy VolunteersYes
Study Sites18

Part A: Inclusion Criteria: * Subject has a body mass index (BMI) between ≥18.0 and \<32.0 kg/m2 * In good health (as determined by the Investigator) based on medical history, physical examination, ECG, and clinical laboratory results. * Female subjects must be non-pregnant and have a negative seru...

Countries:United StatesAustraliaNew Zealand
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Recent Changes (Last 90 Days)
MEDIUMMay 26, 2026NCT06698575TRIAL_REMOVED: changed
LOWMay 24, 2026NCT06698575studyFirstPostDate: changed