Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Eravacycline · 7 trials · 7 indications
This was the co-primary outcome measure for the Food and Drug Administration (FDA). The primary objective was to demonstrate the non-inferiority (NI) of eravacycline to ertapenem in responder outcome, which was derived from both clinical and microbiological responses, in the micro-ITT population. Clinical responses were either cure, failure, or indeterminate/missing; microbiological responses were characterized programmatically as either success, failure, or indeterminate/missing. Clinical cure was defined as complete resolution or significant improvement of signs or symptoms of the infection; microbiological success was a reduction of the baseline pathogen(s) to \<10\^4 colony-forming units/milliliter (CFU/mL). An outcome of Responder required a clinical response of cure and a microbiological response of success. Any other combination of the clinical and microbiological responses was considered either Non-responder or Indeterminate.
This was the co-primary outcome measure for the Food and Drug Administration (FDA). The primary objective was to demonstrate the non-inferiority (NI) of eravacycline to ertapenem in responder outcome, which was derived from both clinical and microbiological responses, in the micro-ITT population. Clinical responses were either cure, failure, or indeterminate/missing; microbiological responses were characterized programmatically as either success, failure, or indeterminate/missing. Clinical cure was defined as complete resolution or significant improvement of signs or symptoms of the infection; microbiological success was a reduction of the baseline pathogen(s) to \<10\^4 colony-forming units/milliliter (CFU/mL). An outcome of responder required a clinical response of cure and a microbiological response of success. Any other combination of the clinical and microbiological responses was considered either Non-responder or Indeterminate.
Clinical cure was defined as complete resolution or significant improvement of signs and symptoms of the index infection such that no additional antibacterial therapy, surgical, or radiological intervention was required. Clinical failure was defined as death related to complicated intra-abdominal infection (cIAI), persistence of clinical symptoms of cIAI, unplanned surgical or percutaneous drainage procedures for complication or recurrence of cIAI, post-surgical wound infections requiring systemic antibiotics, or initiation of rescue antibacterial drug therapy for treatment of cIAI. Indeterminate/missing was defined as an outcome that was neither a clinical cure nor clinical failure, if the investigator did not complete an assessment, if a study visit was not conducted, or if the subject died for a cause unrelated to cIAI.
This was the primary outcome measure for the Food and Drug Administration (FDA). The primary objective was to demonstrate the non-inferiority (NI) of eravacycline to levofloxacin in responder outcome, which was derived from both clinical and microbiological responses, in the micro-ITT population. Clinical responses were either cure, failure, or indeterminate/missing; microbiological responses were characterized programmatically as either success, failure, or indeterminate/missing. Clinical cure was defined as complete resolution or significant improvement of signs or symptoms of the infection; microbiological success was a reduction of the baseline pathogen(s) to \<10\^4 colony-forming units/milliliter (CFU/mL). An outcome of Responder required a clinical response of cure and a microbiological response of success. Any other combination of the clinical and microbiological responses was considered either Non-responder or Indeterminate.
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 \[cIAI\], unplanned surgical procedures or percutaneous drainage procedures, persisting or recurrent infection within the abdomen, postsurgical wound infection, or administration of effective concomitant antibacterial therapy), or indeterminate (outcome was neither cure nor failure, or assessment was not available). Participants who were failures at the End-of-Treatment (EOT) visit (within 24 hours of last dose) were considered failures at the TOC visit. The number of participants with a clinical response classification of cure, failure, or indeterminate is presented.
Cmax, maximum observed plasma concentration
AUC0-t, area under the plasma concentration
AUC0-inf, area under the plasma concentration-time curve extrapolated to infinite time
AUC0-24, area under the plasma concentration-time curve from time 0 to 24 hours after dose
t1/2, elimination half-life
Clast, last observed plasma concentration
CL, systemic clearance
Vd, volume of distribution
To assess the pharmacokinetic (PK) profile of eravacycline after administration of a single intravenous (IV) dose (1.5 mg/kg) to subjects with mild, moderate, and severe impaired hepatic function compared with normal healthy subjects
| Arm | Type | Description |
|---|---|---|
| Eravacycline (Intravenous)/Levofloxacin (Oral) | EXPERIMENTAL | - |
| Ertapenem (Intravenous)/Levofloxacin (Oral) | ACTIVE_COMPARATOR | - |
| Eravacycline | EXPERIMENTAL | - |
| Meropenem | ACTIVE_COMPARATOR | - |
| Levofloxacin | ACTIVE_COMPARATOR | Levofloxacin (750 mg) was administered IV q24h. At minimum, the first 3 doses were administered IV. After an IV-to-PO transition, provided adequate clinical improvement, participants were administered 750 mg PO once a day for a total therapy of 7 dosing cycles. |
| Eravacycline, 1.0 mg/kg q12h | EXPERIMENTAL | Eravacycline was administered intravenously (IV) at a dose of 1.0 milligram per kilogram of body weight (mg/kg) every 12 hours (q12h) for a minimum of 4 days and a maximum of 14 days. Eravacycline 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. |
| Ertapenem, 1.0 g q24h | ACTIVE_COMPARATOR | Ertapenem was administered IV at a dose of 1.0 gram (g) every 24 hours (q24h) for a minimum of 4 days and a maximum of 14 days. 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. |
| Cohort 1 | EXPERIMENTAL | Eravacycline (TP-434) intravenous formulation Eravacycline will be administered as a single 60 minute IV infusion according to age. Age group (years) Dose (mg/kg) 12 to \<18 (Cohort 1) 1.50 |
| Cohort 2 | EXPERIMENTAL | Eravacycline will be administered as a single 60 minute IV infusion according to age. Age group (years) Dose (mg/kg) 8 to \<12 (Cohort 2) 1.75 |
| End stage renal disease (ESRD) subjects | EXPERIMENTAL | A single dose of intravenous eravacycline (1.5 mg/kg) administered over 60 minutes |
| Normal healthy subjects | EXPERIMENTAL | A single dose of intravenous eravacycline (1.5 mg/kg) administered over 60 minutes |
| Impaired hepatic function | EXPERIMENTAL | A single 1.5 mg/kg dose of eravacycline will be administered intravenously on Day 1 as a 60 minute infusion to each hepatically impaired subject. |
| Healthy subjects | EXPERIMENTAL | A single 1.5 mg/kg dose of eravacycline will be administered intravenously on Day 1 as a 60 minute infusion to each healthy subject. |
| Name | Type | Description |
|---|---|---|
| Eravacycline | DRUG | - |
| Ertapenem | DRUG | - |
| Placebo | DRUG | - |
| Levofloxacin | DRUG | - |
| Meropenem | DRUG | - |
| Eravacycline (TP-434) | DRUG | Subjects will be stratified by age into 2 cohorts, as follows: * Cohort 1: from 12 to \<18 years of age (N=8) * Cohort 2: from 8 to \<12 years of age (N=12 or at least 60% of subjects) |
Inclusion Criteria: 1. Male or female participant with either: 1. Pyelonephritis and normal urinary tract anatomy (approximately 50% of the total population), or 2. cUTI with at least one of the following conditions associated with a risk for developing cUTI: * Indwelling urinary cath...
Eravacycline is an investigational small molecule being studied for complicated intra-abdominal infections (cIAI), complicated urinary tract infections (cUTI), end stage renal disease, and impaired hepatic function. It is in clinical development for infectious disease indications and is not yet approved.
Eravacycline is being developed by Innoviva, Inc. (NASDAQ: INVA). The company is conducting clinical trials to evaluate the drug's safety and efficacy in patients with complicated intra-abdominal infections and other conditions.
Eravacycline is in Phase 1 clinical development. While some completed trials were Phase 3, the current development stage is Phase 1, and the drug remains investigational. It has not been approved by the FDA.
Eravacycline has been studied in several trials, including NCT01844856 and NCT02784704, both Phase 3 studies comparing it to ertapenem and meropenem in complicated intra-abdominal infections. Phase 1 trials NCT02135276 and NCT02135302 assessed its pharmacokinetics in renal and hepatic impairment.
Yes, Eravacycline is also known as IV Eravacycline 2mg/kg and Eravacycline/kg. These names refer to the same drug, an intravenous formulation being studied for infectious disease indications.