US-based pharmaceutical firm The Medicines Company has reported the fulfillment of primary endpoints for the investigational antibiotic, Carbavance (meropenem-vaborbactam), in its Phase III TANGO I clinical trial to treat complicated urinary tract infections (cUTI).
The multi-centre, randomised, double-blind, double-dummy Phase III Tango trial was designed to evaluate the efficacy, safety and tolerability of Carbavance when compared to piperacillin-tazobactam to treat cUTI.
Under the US Food and Drug Adminisration (FDA) stated endpoint, assessment was performed in the microbiologic modified intent-to-treat (mMITT) patient population, which resulted to an improvement of the ailment.
For the European Medicines Agency (EMA), the primary assessment had stated the microbiologic outcome as eliminating the bacterial pathogen at the test-of-cure visit in the mMITT and microbiologic evaluable (ME) patient population.
The Medicines Company infectious disease group vice-president and chief medical officer Jeff Loutit said: "Clinical and microbiological responses with Carbavance in Tango I were among the highest of clinical trials recently conducted with new antimicrobial agents.
"The demonstration of superiority with Carbavance treatment over piperacillin-tazobactam in the FDA primary endpoint, and the robust effects in other endpoints, demonstrates the potential gains we can make clinically in the treatment of gram-negative infections.
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"We believe that Tango I provides the pivotal clinical data necessary for the submission of an NDA with the US Food and Drug Administration (FDA) and a marketing authorisation application (MAA) with the European Medicines Agency (EMA)."
Carbavance is a combination of the carbapenem, meropenem, and the novel beta-lactamase inhibitor vaborbactam (formerly known as RPX7009), which is used as a fixed combination by IV infusion and is indicated to treat serious gram-negative infections, such as cUTIs, including infections caused by carbapenems resistant bacteria.