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 being developed for recurrent genital herpes simplex type 2 (HSV-2). It is currently in Phase 1 clinical development and is not approved by the FDA. The drug is being studied in healthy subjects and in subjects seropositive for HSV-2 with recurrent genital herpes.
ABI-1179 is being developed by Assembly Biosciences, Inc., a biopharmaceutical company traded on NASDAQ under the ticker ASMB. The company is conducting clinical trials to evaluate the safety, pharmacokinetics, and tolerability of ABI-1179 in subjects with recurrent genital herpes simplex type 2.
ABI-1179 is in Phase 1 clinical development. A Phase 1 study has been completed, evaluating the safety, pharmacokinetics, and tolerability of the drug in healthy subjects and in subjects seropositive for HSV-2 with recurrent genital herpes. The drug is investigational and has not been approved by regulatory authorities.
ABI-1179 has one completed Phase 1 clinical trial, registered as NCT06698575. The study assessed the safety, pharmacokinetics, and tolerability of ABI-1179 in healthy subjects and in subjects seropositive for HSV-2 with recurrent genital herpes. The trial enrolled 103 participants across the United States, Australia, and New Zealand.
ABI-1179 is not FDA approved. It is an investigational drug currently in Phase 1 clinical development for recurrent genital herpes simplex type 2. The drug has completed a Phase 1 trial, but it has not yet received regulatory approval for any indication.