Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
ABI-5366 · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| Part A: SAD Cohorts 1-5, ABI-5366 | EXPERIMENTAL | Single dose of ABI-5366 (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, ABI-5366 | EXPERIMENTAL | Single dose of ABI-5366 (tablet) in Part A for Cohort 6, food effect |
| Part B: MAD Cohorts 1-4 ABI-5366 | EXPERIMENTAL | Weekly or monthly dose of ABI-5366 (tablet) in Part B for Cohorts 1-4. May have a loading dose. |
| Part B: MAD Cohorts 1-4 Placebo | PLACEBO_COMPARATOR | Weekly or monthly dose of matching placebo (tablet) in Part B for Cohorts 1-4. May have a loading dose. |
| Name | Type | Description |
|---|---|---|
| ABI-5366 | DRUG | Once daily tablet dosing (SAD) or weekly or monthly tablet dosing over the 29-day treatment period (MAD) |
| ABI-5366 Placebo | DRUG | Once daily tablet dosing (SAD) or weekly or monthly tablet dosing over the 29-day treatment period (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 se...
ABI-5366 is an investigational small molecule being developed for recurrent genital herpes simplex type 2, caused by HSV-2. It is not approved for any use and remains in clinical development. Assembly Biosciences is evaluating it as a potential treatment option for people who experience recurrent genital herpes outbreaks.
ABI-5366 targets the HSV helicase-primase, a protein complex the herpes simplex virus needs to replicate its DNA. By acting on this viral enzyme, the drug is designed to interfere with viral replication. This mechanism differs from that of nucleoside-based antivirals that target the viral DNA polymerase.
ABI-5366 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 research pipeline, with recurrent genital herpes simplex type 2 as the lead indication studied to date.
ABI-5366 is in Phase 1 clinical development. It is investigational and has not been approved by the FDA or any other regulatory agency. The completed Phase 1 study enrolled 115 participants and assessed safety, pharmacokinetics, and antiviral activity in healthy volunteers and in people seropositive for HSV-2 with recurrent genital herpes.
ABI-5366 has been studied in one Phase 1 trial, NCT06385327, titled a study to assess the safety, pharmacokinetics, and antiviral activity of ABI-5366 in healthy participants and participants seropositive for HSV-2 with recurrent genital herpes. The trial enrolled 115 participants across Australia and New Zealand and is now completed.
Yes. The Phase 1 trial of ABI-5366, NCT06385327, was randomized, double blind, and placebo controlled. It enrolled 115 participants, including healthy volunteers and individuals seropositive for HSV-2 with recurrent genital herpes, and evaluated safety, pharmacokinetics, and antiviral activity. The study has been completed.