Allecra Therapeutics (“Allecra”) announced today the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for cefepime/enmetazobactam, an antibiotic combination of the fourth generation cephalosporin cefepime with the proprietary beta lactamase inhibitor, enmetazobactam, for the treatment of complicated urinary tract infections (cUTIs). Upon approval, the antibiotic combination will be marketed under the trademark name, EXBLIFEP®. EXBLIFEP® has been designed to combat anti-microbial resistance in gram-negative bacteria, especially resistance mediated by Extended Spectrum Beta Lactamases (or ESBLs). The NDA submission is supported by results from Allecra’s Phase 3 ALLIUM trial, which met criteria for non-inferiority and superiority compared to piperacillin/tazobactam in the primary composite outcome of clinical cure and microbiological eradication in patients with cUTIs.
“This filing marks the culmination of a journey that began ten years ago with the formation of Allecra by a syndicate of European venture capital interests. I am extremely proud of and thankful for our small yet dedicated team which has, since company inception, worked diligently to reach this critical milestone,” said Iain Buchanan, Supervisory Board Member of Allecra Therapeutics.
EXBLIFEP® was granted Qualified Infectious Disease Product (QIDP) status, which can enable priority review from the FDA and enhanced market exclusivity for applications for medicines that, if approved, would provide critical improvements in the efficiency and safety of antibacterial and antifungal drugs to treat serious or life-threatening infections.