The Medicines Company has announced the completion of patient enrollment in the Phase 3 TANGO 1 study of CARBAVANCE® (meropenem-vaborbactam), an investigational agent being developed for the treatment of complicated urinary tract infections (cUTI). TANGO 1 was initiated in the fourth quarter of 2014 under a cost-share agreement with the Biomedical Advanced Research and Development Authority (BARDA) to support the development of CARBAVANCE. Top-line data are expected in the second half of 2016.
“As we announce today the completion of enrollment in this critical Phase 3 study, sooner than originally forecasted, CARBAVANCE continues to move quickly through product development,” said Clive Meanwell, MD, PhD, Chief Executive Officer, The Medicines Company. “CARBAVANCE is targeted at the most deadly and insidious of bacterial threats, namely CRE. We look forward to sharing results from the TANGO 1 study in the near future.”
CARBAVANCE is the combination of the carbapenem antibiotic, meropenem, with the novel beta-lactamase inhibitor, vaborbactam (formerly known as RPX7009), that is being developed for the treatment of gram-negative infections, including those due to carbapenem-resistant Enterobacteriaceae (CRE).
“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 program for CARBAVANCE,” said Michael Dudley, PharmD, Senior Vice President, Head of Health Science R&D, and Co-Leader of the Infectious Diseases Global Innovation Group at The Medicines Company. “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 program.”
TANGO 1 is investigating the safety, tolerability and efficacy of CARBAVANCE in patients with cUTIs or acute pyelonephritis compared to that for piperacillin/tazobactam. Approximately 550 patients were to be randomly assigned (1:1) to receive either CARBAVANCE or piperacillin/tazobactam each given intravenously for up to 10 days. Patients in both arms who met protocol-defined criteria of improvement could be switched to oral levofloxacin after a minimum of 5 days of IV therapy.