Home About the company Cefepime/enmetazobactam Latest information Partnering Contact Antibiotics were once considered one of the greatest successes of modern medicine, saving millions of lives and allowing many procedures that we consider commonplace today to become possible, such as common surgeries, cancer treatments and organ transplants. But today resistance to antibiotics is emerging as one of the biggest healthcare challenges of our time. Read more... β-lactams were once the most widely used antibiotic class because of their known safety and efficacy. Unfortunately, the extensive use of these antibiotics resulted in the emergence of Extended-Spectrum β-lactam resistant pathogens (ESBLs). Today, ESBLs represent a worldwide problem, with high and growing prevalence in both developed and developing countries. What can combat ESBLs? Antibiotics that combine a β-lactams with a β-lactamase inhibitor, such as the widely used piperacillin-tazobactam, or another class of antibiotics called carbapenems. Unfortunately, piperacillin/tazobactam is now also suffering from a growing ESBL-mediated resistance and carbapenem use is restricted by hospitals to prevent the growth of additional resistant pathogens. Allecra is developing cefepime/enmetazobactam to address these critical resistance issues. Cefepime/enmetazobactam has successfully completed a pivotal Phase III trial (ALLIUM) in complicated urinary tract infections (cUTI). The ALLIUM trial was a multi-center, randomized, controlled, double-blind, global study that enrolled 1,034 patients. Patients received either cefepime/enmetazobactam (FPE) or piperacillin-tazobactam (PTZ) via intravenous infusion. The study involved 112 sites in 19 countries. The trial demonstrated superiority in its primary endpoint, with FPE showing a significant improvement over PTZ in the composite success outcome of clinical cure and microbiological eradication at the test-of-cure visit. In the trial, FPE was well tolerated, with 4.3% of patients reporting serious adverse events vs. 3.7 % with PTZ (0.2% vs. 0.6% assessed as drug related), suggesting a comparable safety profile to PTZ. Based on the positive results from this study, Allecra is preparing to submit applications for marketing approval in both the U.S. and Europe, which are expected to be completed in the second half of 2021. Read more... Publications - Kaye, K. et al. Cefepime-Enmetazobactam Demonstrates Superiority to Piperacillin-Tazobactam in a Subgroup of Patients with Complicated Urinary Tract Infections/Acute Pyelonephritis Caused by Extended Spectrum β-Lactamase-Producing Enterobacterales. IDWeek 2020. - Kaye, K. et al. Outcomes of the Novel β-lactam/β-lactamase Inhibitor Combination of Cefepime-Enmetazobactam versus Piperacillin-Tazobactam in Adult Patients with Complicated Urinary Tract Infections – The ALLIUM Phase 3 Trial. ESCMID 2020 - Cassini A, et al. Attributable deaths and disability-adjusted life-years caused by infections with antibiotic-resistant bacteria in the EU and the European Economic Area in 2015: a population-level modelling analysis. The Lancet Infec Dis 2019 Jan 19(1): 56–66. - Belley A, et al. Development of Broth Microdilution MIC and Disk Diffusion Antimicrobial Susceptibility Test Quality Control Ranges for the Combination of Cefepime and the Novel β-lactamase Inhibitor Enmetazobactam. J Clin Microbiol 2019 Jul 26;57(8):e00607-19. - Morrissey I, et al. In vitro activity of cefepime-enmetazobactam against Gram-negative isolates collected from United States and European hospitals during 2014-2015. Antimicrob Agents Chemother 2019 Jul 63(7): e00514-19. - Papp-Wallace KM, et al. Beyond Piperacillin-Tazobactam: Cefepime and AAI101 as a Potent β-Lactam−β-Lactamase Inhibitor Combination. Antimicrob Agents Chemother 2019 May 63(5): e00105-19. - Bush K, Bradford PA. Interplay between beta-lactamases and new beta-lactamase inhibitors. Nat Rev Microbiol 2019 May 17, 295–306. - Tacconelli E, et al. Discovery, research, and development of new antibiotics: the WHO priority list of antibiotic-resistant bacteria and tuberculosis. The Lancet Infec Dis 2018 Mar 18(3):318-327. - Temkin E, et al. Estimating the number of infections caused by antibiotic-resistant Escherichia coli and Klebsiella pneumoniae in 2014: a modelling study. The Lancet Global Health 2018 Sep 6(9):e969-e979. - Bush K. Past and Present Perspectives on beta-Lactamases. Antimicrob Agents Chemother 2018 Oct 62(10): e01076-18. 21/12/2020 Allecra Therapeutics and Shanghai Haini Pharmaceutical Announce Exclusive Licensing Agreement for Cefepime/enmetazobactam for Greater China Download PDF 23/10/2020 Allecra Therapeutics Announces Late-breaker Presentation of Phase 3 ALLIUM Trial with Cefepime-Enmetazobactam in cUTIs at IDWeek 2020 Download PDF 25/02/2020 Allecra Therapeutics Announces Positive Top-Line Results for Phase 3 ALLIUM Clinical Trial of EXBLIFEP® for Complicated Urinary Tract Infections Download PDF Allecra is actively seeking partnerships for the further development and commercialization of cefepime/enmetazobactam. We are open to various opportunities, including global as well as regional licensing agreements. Business development contact: Allecra Therapeutics GmbH Andreas Kranzusch Chief Financial Officer ir@allecra.com +49 761 45899872 Contact information For more information, please contact: Allecra Therapeutics GmbH Andreas Kranzusch Chief Financial Officer ir@allecra.com +49 761 45899872 Imprint Privacy policy Press inquiries MC Services AG allecra@mc-services.eu Europe: Raimund Gabriel, +49 89 210 228 80 U.S: Laurie Doyle, +1 339 832 0752