Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Sulbactam-ETX2514
ETX2514SUL · 2 trials · 3 indications
The primary efficacy endpoint for this study was the proportion of patients with an overall success (clinical cure and micro-biologic eradication) for the m-MITT (Micro-biologically Modified Intent-to-Treat) Population at the TOC Visit.
Venous blood will be collected for ETX2514SUL pharmacokinetic (PK) analyses.
Venous blood will be collected for ETX2514SUL PK analyses.
Venous blood will be collected for ETX2514SUL PK analyses in Period 1. Blood will be collected for ETX2514SUL PK analyses in Period 2 from arterial and venous lines. Hemodialysis will be started approximately 1 hour after the end of infusion. If the hemodialysis session takes longer than 7 hours after the start of infusion, a final sample will be collected at the end of the hemodialysis session.
Venous blood will be collected for ETX2514SUL PK analyses.
Venous blood will be collected for ETX2514SUL PK analyses.
Venous blood will be collected for ETX2514SUL PK analyses in Period 1. Blood will be collected for ETX2514SUL PK analyses in Period 2 from arterial and venous lines. Hemodialysis will be started approximately 1 hour after the end of infusion. If the hemodialysis session takes longer than 7 hours after the start of infusion, a final sample will be collected at the end of the hemodialysis session.
AUC0-24 is defined as the area under the concentration versus time curve from time zero to 24 hours postdose. Venous blood will be collected for ETX2514SUL PK analyses.
AUC0-48 is defined as the area under the concentration versus time curve from time zero to 48 hours postdose. Venous blood will be collected for ETX2514SUL PK analyses.
AUC0-last is defined as the area under the concentration versus time curve from time zero to the time of the last quantifiable concentration after dosing. Venous blood will be collected for ETX2514SUL PK analyses.
AUC0-∞ is defined as the area under the concentration versus time curve from time zero extrapolated to infinity. Venous blood will be collected for ETX2514SUL PK analyses.
AUC0-24 is defined as the area under the concentration versus time curve from time zero to 24 hours postdose. Venous blood will be collected for ETX2514SUL PK analyses.
AUC0-48 is defined as the area under the concentration versus time curve from time zero to 48 hours postdose. Venous blood will be collected for ETX2514SUL PK analyses.
AUC0-60 is defined as the area under the concentration versus time curve from time zero to 60 hours. Venous blood will be collected for ETX2514SUL PK analyses.
AUC0-last is defined as the area under the concentration versus time curve from time zero to the time of the last quantifiable concentration after dosing. Venous blood will be collected for ETX2514SUL PK analyses.
AUC0-∞ is defined as the area under the concentration versus time curve from time zero extrapolated to infinity. Venous blood will be collected for ETX2514SUL PK analyses.
AUC0-24 is defined as the area under the concentration versus time curve from time zero to 24 hours postdose. Venous blood will be collected for ETX2514SUL PK analyses in Period 1. Blood will be collected for ETX2514SUL PK analyses in Period 2 from arterial and venous lines. Hemodialysis will be started approximately 1 hour after the end of infusion. If the hemodialysis session takes longer than 7 hours after the start of infusion, a final sample will be collected at the end of the hemodialysis session.
AUC0-48 is defined as the area under the concentration versus time curve from time zero to 48 hours postdose. Venous blood will be collected for ETX2514SUL PK analyses in Period 1. Blood will be collected for ETX2514SUL PK analyses in Period 2 from arterial and venous lines. Hemodialysis will be started approximately 1 hour after the end of infusion. If the hemodialysis session takes longer than 7 hours after the start of infusion, a final sample will be collected at the end of the hemodialysis session.
AUC0-60 is defined as the area under the concentration versus time curve from time zero to 60 hours postdose. Venous blood will be collected for ETX2514SUL PK analyses in Period 1. Blood will be collected for ETX2514SUL PK analyses in Period 2 from arterial and venous lines. Hemodialysis will be started approximately 1 hour after the end of infusion. If the hemodialysis session takes longer than 7 hours after the start of infusion, a final sample will be collected at the end of the hemodialysis session.
AUC0-last is defined as the area under the concentration versus time curve from time zero to the time of the last quantifiable concentration after dosing. Venous blood will be collected for ETX2514SUL PK analyses in Period 1. Blood will be collected for ETX2514SUL PK analyses in Period 2 from arterial and venous lines. Hemodialysis will be started approximately 1 hour after the end of infusion. If the hemodialysis session takes longer than 7 hours after the start of infusion, a final sample will be collected at the end of the hemodialysis session.
AUC0-∞ is defined as the area under the concentration versus time curve from time zero extrapolated to infinity. Venous blood will be collected for ETX2514SUL PK analyses in Period 1. Blood will be collected for ETX2514SUL PK analyses in Period 2 from arterial and venous. Hemodialysis will be started approximately 1 hour after the end of infusion. If the hemodialysis session takes longer than 7 hours after the start of infusion, a final sample will be collected at the end of the hemodialysis session.
Venous blood will be collected for ETX2514SUL PK analyses at predose, and 0.5, 1, 2, 3, 3.5, 4, 5, 6, 7, 8, 12, 24, 36, and 48 hours after the start of infusion ("postdose"). Infusion can begin at any time on Day 1; thus, 48 hours post infusion could fall on Day 3.
Venous blood will be collected for ETX2514SUL PK analyses at predose, and 0.5, 1, 2, 3, 3.5, 4, 5, 6, 7, 8, 12, 24, 36, 48, and 60 hours after the start of infusion ("postdose"). Infusion can begin at any time on Day 1; thus, 60 hours post infusion could fall on Day 4.
Venous blood will be collected for ETX2514SUL PK analyses in Period 1 at predose, and 0.5, 1, 2, 3, 3.5, 4, 5, 6, 7, 8, 10, 12, 16, 24, 36, 48, and 60 hours after the start of infusion. Blood will be collected for ETX2514SUL PK analyses in Period 2 from arterial and venous lines at approximately 4, 5, 6, and 7 hours after the start of infusion (where hemodialysis will be started approximately 1 hour after the end of infusion). If the hemodialysis session takes longer than 7 hours after the start of infusion, a final sample will be collected at the end of the hemodialysis session. Infusion can begin at any time on Day 1; thus, 60 hours post infusion could fall on Day 4.
Venous blood will be collected for ETX2514SUL PK analyses at predose, and 0.5, 1, 2, 3, 3.5, 4, 5, 6, 7, 8, 12, 24, 36, and 48 hours after the start of infusion ("postdose"). Infusion can begin at any time on Day 1; thus, 48 hours post infusion could fall on Day 3.
Venous blood will be collected for ETX2514SUL PK analyses at predose, and 0.5, 1, 2, 3, 3.5, 4, 5, 6, 7, 8, 12, 24, 36, 48, and 60 hours after the start of infusion ("postdose"). Infusion can begin at any time on Day 1; thus, 60 hours post infusion could fall on Day 4.
Venous blood will be collected for ETX2514SUL PK analyses in Period 1 at predose, and 0.5, 1, 2, 3, 3.5, 4, 5, 6, 7, 8, 10, 12, 16, 24, 36, 48, and 60 hours after the start of infusion. Blood will be collected for ETX2514SUL PK analyses in Period 2 from arterial and venous lines at approximately 4, 5, 6, and 7 hours after the start of infusion (where hemodialysis will be started approximately 1 hour after the end of infusion). If the hemodialysis session takes longer than 7 hours after the start of infusion, a final sample will be collected at the end of the hemodialysis session. Infusion can begin at any time on Day 1; thus, 60 hours post infusion could fall on Day 4.
Venous blood will be collected for ETX2514SUL PK analyses at predose, and 0.5, 1, 2, 3, 3.5, 4, 5, 6, 7, 8, 12, 24, 36, and 48 hours after the start of infusion ("postdose"). Infusion can begin at any time on Day 1; thus, 48 hours post infusion could fall on Day 3.
Venous blood will be collected for ETX2514SUL PK analyses at predose, and 0.5, 1, 2, 3, 3.5, 4, 5, 6, 7, 8, 12, 24, 36, 48, and 60 hours after the start of infusion ("postdose"). Infusion can begin at any time on Day 1; thus, 60 hours post infusion could fall on Day 4.
Venous blood will be collected for ETX2514SUL PK analyses in Period 1 at predose, and 0.5, 1, 2, 3, 3.5, 4, 5, 6, 7, 8, 10, 12, 16, 24, 36, 48, and 60 hours after the start of infusion. Blood will be collected for ETX2514SUL PK analyses in Period 2 from arterial and venous lines at approximately 4, 5, 6, and 7 hours after the start of infusion (where hemodialysis will be started approximately 1 hour after the end of infusion). If the hemodialysis session takes longer than 7 hours after the start of infusion, a final sample will be collected at the end of the hemodialysis session. Infusion can begin at any time on Day 1; thus, 60 hours post infusion could fall on Day 4.
Venous blood will be collected for ETX2514SUL PK analyses at predose, and 0.5, 1, 2, 3, 3.5, 4, 5, 6, 7, 8, 12, 24, 36, and 48 hours after the start of infusion ("postdose"). Infusion can begin at any time on Day 1; thus, 48 hours post infusion could fall on Day 3.
Venous blood will be collected for ETX2514SUL PK analyses at predose, and 0.5, 1, 2, 3, 3.5, 4, 5, 6, 7, 8, 12, 24, 36, 48, and 60 hours after the start of infusion ("postdose"). Infusion can begin at any time on Day 1; thus, 60 hours post infusion could fall on Day 4.
Venous blood will be collected for ETX2514SUL PK analyses in Period 1 at predose, and 0.5, 1, 2, 3, 3.5, 4, 5, 6, 7, 8, 10, 12, 16, 24, 36, 48, and 60 hours after the start of infusion. Blood will be collected for ETX2514SUL PK analyses in Period 2 from arterial and venous lines at approximately 4, 5, 6, and 7 hours after the start of infusion (where hemodialysis will be started approximately 1 hour after the end of infusion). If the hemodialysis session takes longer than 7 hours after the start of infusion, a final sample will be collected at the end of the hemodialysis session. Infusion can begin at any time on Day 1; thus, 60 hours post infusion could fall on Day 4.
Urine for ETX2514SUL PK analyses will be collected continuously from participants capable of producing urine at the following intervals: predose (a single void within 30 minutes prior to the start of infusion) and 0 to 4, 4 to 8, 8 to 12, and 12 to 24 hours after the start of infusion. Infusion can begin at any time on Day 1; thus, 24 hours post infusion could fall on Day 2.
Urine for ETX2514SUL PK analyses will be collected continuously from participants capable of producing urine at the following intervals: predose (a single void within 30 minutes prior to the start of infusion), and 0 to 4, 4 to 8, 8 to 12, 12 to 24, 24 to 36, 36 to 48, and 48 to 60 hours after the start of infusion. Infusion can begin at any time on Day 1; thus, 60 hours post infusion could fall on Day 4.
Urine for ETX2514SUL PK analyses will be collected continuously from participants capable of producing urine at the following intervals: predose (a single void within 30 minutes prior to the start of infusion) and 0 to 4, 4 to 8, 8 to 12, and 12 to 24 hours after the start of infusion. Infusion can begin at any time on Day 1; thus, 24 hours post infusion could fall on Day 2.
Urine for ETX2514SUL PK analyses will be collected continuously from participants capable of producing urine at the following intervals: predose (a single void within 30 minutes prior to the start of infusion), and 0 to 4, 4 to 8, 8 to 12, 12 to 24, 24 to 36, 36 to 48, and 48 to 60 hours after the start of infusion. Infusion can begin at any time on Day 1; thus, 60 hours post infusion could fall on Day 4.
Urine for ETX2514SUL PK analyses will be collected continuously from participants capable of producing urine at the following intervals: predose (a single void within 30 minutes prior to the start of infusion) and 0 to 4, 4 to 8, 8 to 12, and 12 to 24 hours after the start of infusion. Infusion can begin at any time on Day 1; thus, 24 hours post infusion could fall on Day 2.
Urine for ETX2514SUL PK analyses will be collected continuously from participants capable of producing urine at the following intervals: predose (a single void within 30 minutes prior to the start of infusion), and 0 to 4, 4 to 8, 8 to 12, 12 to 24, 24 to 36, 36 to 48, and 48 to 60 hours after the start of infusion. Infusion can begin at any time on Day 1; thus, 60 hours post infusion could fall on Day 4.
Venous blood will be collected for ETX2514SUL PK analyses in Period 1 at predose, and 0.5, 1, 2, 3, 3.5, 4, 5, 6, 7, 8, 10, 12, 16, 24, 36, 48, and 60 hours after the start of infusion. Blood will be collected for ETX2514SUL PK analyses in Period 2 from arterial and venous lines at approximately 4, 5, 6, and 7 hours after the start of infusion (where hemodialysis will be started approximately 1 hour after the end of infusion). If the hemodialysis session takes longer than 7 hours after the start of infusion, a final sample will be collected at the end of the hemodialysis session. Infusion can begin at any time on Day 1; thus, 60 hours post infusion could fall on Day 4.
Venous blood will be collected for ETX2514SUL PK analyses in Period 1 at predose, and 0.5, 1, 2, 3, 3.5, 4, 5, 6, 7, 8, 10, 12, 16, 24, 36, 48, and 60 hours after the start of infusion. Blood will be collected for ETX2514SUL PK analyses in Period 2 from arterial and venous lines at approximately 4, 5, 6, and 7 hours after the start of infusion (where hemodialysis will be started approximately 1 hour after the end of infusion). If the hemodialysis session takes longer than 7 hours after the start of infusion, a final sample will be collected at the end of the hemodialysis session. Infusion can begin at any time on Day 1; thus, 60 hours post infusion could fall on Day 4.
Venous blood will be collected for ETX2514SUL PK analyses in Period 1 at predose, and 0.5, 1, 2, 3, 3.5, 4, 5, 6, 7, 8, 10, 12, 16, 24, 36, 48, and 60 hours after the start of infusion. Blood will be collected for ETX2514SUL PK analyses in Period 2 from arterial and venous lines at approximately 4, 5, 6, and 7 hours after the start of infusion (where hemodialysis will be started approximately 1 hour after the end of infusion). If the hemodialysis session takes longer than 7 hours after the start of infusion, a final sample will be collected at the end of the hemodialysis session. Infusion can begin at any time on Day 1; thus, 60 hours post infusion could fall on Day 4.
| Arm | Type | Description |
|---|---|---|
| Sulbactam-ETX2514 (ETX2514SUL) + Imipenem/Cilastatin | EXPERIMENTAL | - |
| Placebo + Imipenem/Cilastatin | PLACEBO_COMPARATOR | - |
| Cohort 1, Normal Renal Function | EXPERIMENTAL | Healthy control participants matched to participants enrolled in Cohort 4 (creatinine clearance ≥90 milliliters per minute \[mL/min\] estimated by the Cockcroft-Gault equation) will receive ETX2514SUL as a single dose of up to 1000 milligrams (mg) ETX2514 and 1000 mg sulbactam given by concurrent 3-hour intravenous (IV) infusion. |
| Cohort 2, Mild Renal Impairment | EXPERIMENTAL | Participants with mild renal impairment (estimated glomerular filtration rate \[eGFR\] ≥60 to \<90 mL/min/1.73 meters squared \[m\^2\] calculated by the Modified Diet in Renal Disease \[MDRD\] equation) will receive ETX2514SUL as a single dose of up to 1000 mg ETX2514 and 1000 mg sulbactam given by concurrent 3-hour IV infusion. |
| Cohort 3, Moderate Renal Impairment | EXPERIMENTAL | Participants with moderate renal impairment (eGFR ≥30 to \<60 mL/min/1.73 m\^2 calculated by the MDRD equation) will receive ETX2514SUL as a single dose of up to 1000 mg ETX2514 and 1000 mg sulbactam given by concurrent 3-hour IV infusion. |
| Cohort 4, Severe Renal Impairment | EXPERIMENTAL | Participants with severe renal impairment (eGFR \<30 mL/min/1.73 m\^2 calculated by the MDRD equation) and not on hemodialysis (HD) will receive ETX2514SUL as a single dose of up to 1000 mg ETX2514 and 1000 mg sulbactam given by concurrent 3-hour IV infusion. |
| Cohort 5, ESRD on a Stable HD Regimen | EXPERIMENTAL | Participants with end-stage renal disease (ESRD) on a stable HD regimen (determined by medical history) will receive ETX2514SUL as a single dose of up to 1000 mg ETX2514 and 1000 mg sulbactam given by concurrent 3-hour IV infusion. |
| Name | Type | Description |
|---|---|---|
| Sulbactam-ETX2514 | DRUG | The ETX2514SUL regimen of 1 g ETX2514/1 g sulbactam infused over 3 hours q6h. |
| Placebo | DRUG | Matching 1g IV solution. |
| Imipenem-cilastatin | DRUG | All patients will receive background therapy with 500 mg IV imipenem/cilastatin q6h. |
| ETX2514SUL | DRUG | Single dose of up to 1000 mg ETX2514 and 1000 mg sulbactam given by concurrent 3-hr IV infusion |
Inclusion Criteria: * A signed informed consent form (ICF). If a study patient is unable to provide informed consent due to their medical condition, the patient's legally authorized representative may consent on behalf of the study patient as permitted by local law and institutional Standard Operat...
ETX2514SUL is being developed for the treatment of Acinetobacter baumannii infection. It is an investigational small molecule therapeutic that has been studied in a Phase 1 clinical trial. It is not yet approved for commercial use, and its development remains at the early clinical stage.
ETX2514SUL is being developed by Innoviva, Inc., which trades on the Nasdaq under the ticker INVA. Innoviva is the sponsor of the clinical program evaluating this investigational small molecule for Acinetobacter baumannii infection.
ETX2514SUL is in Phase 1 clinical development. The program has completed one Phase 1 trial to date, and no active trials are currently listed. It is an investigational agent and has not been approved by the FDA for any indication.
ETX2514SUL has been evaluated in the Phase 1 trial NCT03310463, titled Evaluation of the Pharmacokinetics, Safety, and Tolerability of Intravenous ETX2514 and Sulbactam Administered Concurrently to Subjects With Various Degrees of Renal Impairment and Healthy Matched Control Subjects. The trial enrolled 34 participants in the United States and has been completed.
The Phase 1 trial NCT03310463 was a controlled study evaluating intravenous ETX2514 and sulbactam administered together in subjects with various degrees of renal impairment alongside healthy matched control subjects. It enrolled 34 participants aged 18 years and older, including healthy volunteers, and has been completed.