US-based The Medicines Company has completed patient enrolment in a Phase lll study of carbavance (meropenem-vaborbactam), an investigational agent being developed to treat complicated urinary tract infections (cUTI).
The Phase lll TANGO 1 trial is investigating the safety, tolerability and efficacy of carbavance in patients with cUTIs or acute pyelonephritis compared to that for piperacillin / tazobactam.
Around 550 patients were to be randomly selected to receive either carbavance or piperacillin / tazobactam, each given intravenously for up to ten days.
In 2014, The Medicines Company, along with Biomedical Advanced Research and Development Authority (BARDA), US, had started the TANGO 1 trial to develop carbavance, a combination of the carbapenem antibiotic, meropenem, and the new beta-lactamase inhibitor, vaborbactam.
Previously, vaborbactam (formerly known as RPX7009) was being developed to treat gram-negative infections, including those due to carbapenem-resistant Enterobacteriaceae (CRE).
Data from the trial is expected in the second half of this year.
The Medicines Company infectious diseases global innovation group co-leader Michael Dudley said: "Completion of patient enrollment in the TANGO 1 trial in patients with cUTI, along with Fast Track designation for potential indications in cUTIs, are important milestones in the accelerated development programme for carbavance.
"Support from BARDA has allowed us to continue delivering on our commitment to advance new antimicrobial drugs to address the most serious and urgent drug-resistant infections.
"It is patients with limited treatment options that carbavance is intended to help. Timely and helpful guidance from the FDA and European regulators has also been instrumental in enabling execution of an efficient Phase III programme."
The company noted that two TANGO Phase lll clinical trials are currently happening.
The TANGO 2 trial is comparing carbavance’s safety, tolerability, and efficacy with available therapy in patients suffering from serious infections due to confirmed or suspected CRE.
During the trial, subjects with cUTI, nosocomial pneumonia, intra-abdominal infections and / or bacteremia will be randomly assigned to carbavance or ‘best available therapy’ for up to 14 days.