Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Vabomere · 2 trials · 7 indications
Overall success is defined as clinical cure \& microbiological eradication. Eradication defined by FDA as the demonstration that the bacterial pathogen(s) found at baseline is reduced to \<10x4 colony forming unit (CFU)/mL urine. Clinical cure defined as complete resolution or significant improvement of the baseline signs \& symptoms, no further antimicrobial warranted.
The All-cause mortality rate at Day 28 in the mCRE-MITT population (HABP/VABP and Bacteremia)
Clinical cure defined as complete resolution or significant improvement of the baseline signs and symptoms, no further antimicrobial warranted.
AUC from time zero to infinity
maximum measured plasma concentration
time to Cmax
total body clearance
elimination half- life
minimum plasma concentration
Volume of distribution
a composite measure of the number and types of AEs/SAEs encountered and relationship to time of dosing
A composite measure of multiple laboratory results assessing the clinical significance of any changes from baseline
A composite of multiple vital sign measurements, assessing the clinical significance of any changes from baseline
A composite of multiple ECG measurements, assessing the clinical significance of any changes from baseline
| Arm | Type | Description |
|---|---|---|
| Vabomere | EXPERIMENTAL | Vabomere (meropenem 2g plus vaborbactam 2g) IV q8h, for up to 14 days |
| Best Available Therapy | ACTIVE_COMPARATOR | Subjects will receive Best Available Therapy (IV antibiotics) |
| Single dose IV meropenem-vaborbactam | EXPERIMENTAL | Vabomere (meropenem-vaborbactam) for IV injection will be administered as a single dose diluted in normal saline infused IV over 3 hours * Cohort 1 (n=8): 12 to \< 18 years of age (40 mg/kg) * Cohort 2 (n=8): 6 to \< 12 years of age (40 mg/kg) * Cohort 2b (n=4): 6 to \< 12 years of age (60 mg/kg) * Cohort 3 (n=8): 2 to \< 6 years of age (60 mg/kg) * Cohort 4 (n=8): 3 months to \< 2 years of age (60 mg/kg) * Cohort 5 (n=24): Birth to \< 3 months of age (dose TBD) * Group A: Gestational Age (GA) \< 32 weeks, Postnatal Age (PNA) \< 2 weeks (n=6) * Group B: GA \< 32 weeks, PNA \> 2 weeks (n=6) * Group C: GA \> 32 weeks, PNA \< 2 weeks (n=6) * Group D: GA \> 32 weeks, PNA \> 2 weeks (n=6) * Cohort 6 (n=7): 2 to \< 12 years of age and ≤ 35 kg of weight (80 mg/kg) |
| Name | Type | Description |
|---|---|---|
| Vabomere | DRUG | Vabomere for IV injection, administered as a 2 g/2 g dose |
| Best Available Therapy | DRUG | Antibiotic(s) chosen by Investigator |
* Inclusion Criteria: 1. Willingness to comply with all study activities and procedures and to provide signed, written informed consent prior to any study procedures. If a subject is unable to provide informed consent due to their medical condition, the subject's legal representative will be prov...
Vabomere is an investigational small molecule being developed for bacterial infections, including complicated urinary tract infection, acute pyelonephritis, hospital acquired bacterial pneumonia, ventilator-associated bacterial pneumonia, bacteremia, and abdominal infection. It is being studied in adult and pediatric patients with serious bacterial infections.
Vabomere is being developed by CorMedix Inc., a biopharmaceutical company traded on the NYSE American under the ticker symbol CRMD. The company is conducting clinical trials to evaluate the drug's efficacy, safety, and pharmacokinetics in patients with bacterial infections.
Vabomere is in clinical development. A Phase 3 trial (NCT02168946) comparing Vabomere to best available therapy in adults with serious infections has been completed, and a Phase 1 trial (NCT02687906) in pediatric subjects with bacterial infections is active but not recruiting. The drug is not yet approved.
Vabomere has been studied in two clinical trials. NCT02168946 was a completed Phase 3 trial in adults with complicated urinary tract infection, acute pyelonephritis, hospital acquired bacterial pneumonia, ventilator-associated bacterial pneumonia, bacteremia, or abdominal infection. NCT02687906 is an active Phase 1 dose-finding, pharmacokinetics, and safety trial in pediatric subjects with bacterial infections.
Vabomere is the brand name for the drug being developed by CorMedix Inc. No alternative names for Vabomere have been disclosed in the clinical trial information. The drug is being studied under the name Vabomere in both adult and pediatric clinical trials.