Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
ABI-1179 · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| Part A: SAD Cohorts 1-5, ABI-1179 | EXPERIMENTAL | Single dose of ABI-1179 (tablet) in Part A for cohorts 1-5 |
| Part A:SAD Cohorts 1-5, Placebo | PLACEBO_COMPARATOR | Single dose of matching placebo (tablet) in Part A for Cohorts 1-5 |
| Part A: (SAD) Fed Cohort 6 or 7, ABI-1179 | EXPERIMENTAL | Single dose of ABI-1179 (tablet) in Part A for Cohort 6 or 7, food effect |
| Part B: MAD Cohorts 1-4, ABI-1179 | EXPERIMENTAL | Weekly dose ofABI-1179 (tablet) in Part B for Cohorts 1-4. May have loading dose. |
| Part B: MAD Cohorts 1-4 Placebo | PLACEBO_COMPARATOR | Weekly dose of matching placebo (tablet) in Part B for Cohorts 1-4. |
| Name | Type | Description |
|---|---|---|
| ABI-1179 | DRUG | Once daily tablet dosing (SAD), or weekly tablet dosing over 29 days (MAD) |
| ABI-1179 Placebo | DRUG | Once daily tablet dosing (SAD), or weekly tablet dosing over 29 days (MAD) |
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...
ABI-1179 is an investigational small molecule antiviral developed by Assembly Biosciences, Inc. for recurrent genital herpes simplex type 2. It is being studied as an oral treatment for HSV-2 infection and is currently in Phase 1 clinical development. It has not been approved by the FDA.
ABI-1179 is being developed for the treatment of recurrent genital herpes simplex type 2, an infectious disease caused by HSV-2. The clinical program has studied the drug in healthy subjects and in subjects seropositive for HSV-2 with recurrent genital herpes. It remains investigational and is not approved for any use.
ABI-1179 targets the herpes simplex virus helicase-primase complex, a viral protein essential for viral DNA replication. By acting on this viral target rather than a host protein, the small molecule is designed to interfere directly with the HSV-2 replication machinery. This mechanism differs from that of nucleoside-based antivirals.
ABI-1179 is being developed by Assembly Biosciences, Inc., which trades on the Nasdaq under the ticker ASMB. The company is advancing the compound as part of its antiviral pipeline, with the HSV-2 program focused on recurrent genital herpes.
ABI-1179 is in Phase 1 clinical development. One Phase 1 trial has been completed, and no active trials are currently listed. The drug is investigational and has not received FDA approval. The completed study was randomized, double-blind, and placebo-controlled, enrolling 103 participants.
ABI-1179 has been evaluated in the Phase 1 trial NCT06698575, titled A Study to Assess the Safety, Pharmacokinetics, and Tolerability of ABI-1179 in Healthy Subjects and in Subjects Seropositive for HSV-2 With Recurrent Genital Herpes. The completed trial enrolled 103 participants across the United States, Australia, and New Zealand.