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 (HSV-2). It is currently in Phase 1 clinical development and is not yet approved by the FDA. The drug is being studied for its safety, pharmacokinetics, and antiviral activity in healthy participants and those seropositive for HSV-2.
ABI-5366 is being developed by Assembly Biosciences, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol ASMB. The company is conducting clinical trials to evaluate the drug's safety and antiviral activity in patients with recurrent genital herpes simplex type 2.
ABI-5366 is in Phase 1 clinical development. A Phase 1 study has been completed, evaluating the drug in healthy participants and participants seropositive for HSV-2 with recurrent genital herpes. The drug remains investigational and has not received FDA approval.
ABI-5366 has one completed Phase 1 clinical trial, identified as NCT06385327. This randomized, double-blind, placebo-controlled study enrolled 115 participants in Australia and New Zealand to assess the safety, pharmacokinetics, and antiviral activity of ABI-5366 in healthy participants and those with recurrent genital herpes simplex type 2.
ABI-5366 is a small molecule antiviral agent. Its specific molecular target has not been disclosed in available information. The drug is being studied for its ability to reduce viral activity in patients with recurrent genital herpes simplex type 2, based on its antiviral properties observed in clinical trials.