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Also known as TP-434
TP-434 reconstituted and administered via an infusion · 2 trials · 2 indications
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. |
| TP-434 (Eravacycline) via IV infusion | EXPERIMENTAL | TP-434 (Eravacycline) reconstituted and administered via IV infusion at a dose of 1 mg/kg, every 12 hours, for 7 doses over 4 days. |
| Name | Type | Description |
|---|---|---|
| TP-434 | DRUG | - |
| Ertapenem | DRUG | - |
| Placebo | DRUG | Administered IV to maintain the blind. |
| TP-434 (Eravacycline) reconstituted and administered via an IV infusion | DRUG | - |
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 antibiotic studied for complicated intra-abdominal infections. It has also been evaluated in a pharmacokinetic study of bronchopulmonary disposition in healthy adults. It is being developed by Innoviva, Inc. (INVA) and remains in clinical development rather than approved for commercial use.
TP-434 is being developed by Innoviva, Inc., which trades on the Nasdaq under the ticker INVA. Innoviva holds the development program for this small-molecule antibiotic candidate, which has been studied in complicated intra-abdominal infection and in a healthy-volunteer pharmacokinetic trial.
TP-434 is in Phase 2 development. Its Phase 2 trial in community-acquired complicated intra-abdominal infections has been completed, and a Phase 1 pharmacokinetic study in healthy volunteers has also been completed. The drug is investigational and has not been approved by the FDA.
TP-434 has been studied in two completed trials. NCT01265784 was a Phase 2 study comparing TP-434 with ertapenem in community-acquired complicated intra-abdominal infections, enrolling 143 patients across the United States, Bulgaria, India, Latvia, Lithuania, and Romania. NCT01989949 was a Phase 1 pharmacokinetic study of bronchopulmonary disposition in 20 healthy adults in the United States.
Yes. TP-434 is the same compound as eravacycline, and the names are used interchangeably in trial records. The Phase 2 intra-abdominal infection study is titled with TP-434, while the Phase 1 pharmacokinetic study is titled with IV eravacycline (TP-434), reflecting the same investigational antibiotic.
TP-434 is reconstituted and administered via an intravenous infusion. The Phase 1 pharmacokinetic study evaluated IV eravacycline (TP-434) to assess bronchopulmonary disposition in healthy men and women, and the Phase 2 trial in complicated intra-abdominal infections used the same intravenous route of administration.