Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
TP-434 · 1 trial · 1 indication
Clinical response was classified as cure (complete resolution or significant improvement of signs and symptoms of the index infection), failure (death related to complicated intra-abdominal infection \[cIAI\], persisting or recurrent infection within the abdomen, postsurgical wound infection, or administration of effective concomitant antibacterial therapy), or indeterminate (Test-of-Cure \[TOC\] assessment was not available, death unrelated to cIAI, or some other reason).
| Arm | Type | Description |
|---|---|---|
| TP-434, 1.5 mg/kg q24h | EXPERIMENTAL | TP-434 was administered intravenously (IV) at a dose of 1.5 milligrams per kilogram of body weight (mg/kg) every 24 hours (q24h) for a minimum of 4 days and a maximum of 14 days (7 days for participants in India). TP-434 treatment was to be stopped when symptoms of complicated intra-abdominal infection (cIAI) resolved, there was treatment failure, or the maximum allowed number of infusion days was reached. |
| TP-434, 1.0 mg/kg q12h | EXPERIMENTAL | TP-434 was administered IV at a dose of 1.0 mg/kg every 12 hours (q12h) for a minimum of 4 days and a maximum of 14 days (7 days for participants in India). TP-434 treatment was to be stopped when symptoms of cIAI resolved, there was treatment failure, or the maximum allowed number of infusion days was reached. |
| Ertapenem, 1 g q24h | ACTIVE_COMPARATOR | Ertapenem was administered IV at a dose of 1 gram (g) q24h for a minimum of 4 days and a maximum of 14 days (7 days for participants in India). Ertapenem treatment was to be stopped when symptoms of cIAI resolved, there was treatment failure, or the maximum allowed number of infusion days was reached. |
| Name | Type | Description |
|---|---|---|
| TP-434 | DRUG | - |
| Ertapenem | DRUG | - |
| Placebo | DRUG | Administered IV to maintain the blind. |
Inclusion Criteria: * Abdominal pain/discomfort with onset prior to hospitalization * Evidence of a systemic inflammatory response * Physical findings consistent with intra-abdominal infection (IAI) * Clinical diagnosis of community-acquired IAI requiring urgent surgical or percutaneous interventio...
TP-434 is an investigational small molecule being developed for the treatment of complicated intra-abdominal infection, a serious bacterial infection within the abdominal cavity. It is currently in Phase 2 clinical development and has not been approved by regulatory authorities.
TP-434 is a small molecule antibiotic designed to treat complicated intra-abdominal infections. Its specific molecular target has not been disclosed in available clinical trial information. The drug is being studied for its ability to combat bacterial infections in the abdominal region.
TP-434 is being developed by Innoviva, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol INVA. The company is conducting clinical trials to evaluate the drug's safety and efficacy in patients with complicated intra-abdominal infections.
TP-434 is in Phase 2 clinical development. It has completed one Phase 2 trial and is not yet approved for commercial use. The drug remains investigational and is being studied for the treatment of complicated intra-abdominal infection.
TP-434 has one completed clinical trial, NCT01265784, a Phase 2 study comparing TP-434 to ertapenem in community-acquired complicated intra-abdominal infections. The trial enrolled 143 participants across the United States, Bulgaria, India, Latvia, Lithuania, and Romania.
TP-434 is also known as eravacycline, a fluorocycline antibiotic. In clinical trials, it has been studied under the name TP-434. The drug is being developed by Innoviva, Inc. for the treatment of complicated intra-abdominal infections.