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-- ZEMDRI is the only once-daily aminoglycoside therapy FDA-approved for use in complicated urinary tract infections (cUTI) --
-- Treatment with ZEMDRI resulted in a greater than four-fold reduction in relapse of cUTI clinical symptoms compared to meropenem at Day 28 --
SOUTH SAN FRANCISCO, Calif., Feb. 21, 2019 (GLOBE NEWSWIRE) -- Achaogen, Inc. (Nasdaq: AKAO), a biopharmaceutical company discovering, developing and commercializing innovative antibacterial agents to address multi-drug resistant (MDR) gram-negative infections, today announced that the New England Journal of Medicine has published the results from the Phase 3 EPIC (Evaluating Plazomicin In cUTI) study of ZEMDRI. The publication describes the efficacy and safety of ZEMDRI in adult patients with complicated urinary tract infections (cUTI), including acute pyelonephritis. The article appears in the February 21, 2019 issue of the Journal.
“The effective treatment of complicated urinary tract infections is increasingly becoming more challenging because of the growing problem of antimicrobial resistance,” said Florian M.E. Wagenlehner, M.D., Director, Clinic for Urology, Pediatric Urology and Andrology, Justus Liebig University Giessen, Germany. “The randomized clinical trial EPIC successfully evaluated plazomicin, which is a once-daily aminoglycoside for cUTI with biological activity against multi-drug resistant bacteria. The potential for ZEMDRI to address difficult-to-treat infections and my comfort with its safety profile are important attributes when considering a patient’s treatment options.”
The Phase 3 EPIC clinical trial was the first multicenter, multinational, randomized, double-blind and controlled study of once-daily aminoglycoside therapy for the treatment of cUTI, including acute pyelonephritis. The article, entitled Once-Daily Plazomicin for Complicated Urinary Tract Infections is summarized as follows:
cUTI is defined as a UTI occurring in a patient with an underlying complicating factor of the genitourinary tract, such as a structural or functional abnormality.2 Patients with pyelonephritis, regardless of underlying abnormalities of the urinary tract, are considered a subset of patients with cUTI.3 An estimated 3 million cases of cUTI are treated in the hospital setting in the U.S. each year.4 Enterobacteriaceae are the most common pathogens causing cUTIs5, and resistance within this family is a global concern. High rates of resistance to previous mainstays of therapy necessitate alternative treatment options. Ineffectively managed cUTI can lead to increased treatment failure rates, recurrence of infection, increased re-hospitalization, and increased morbidity and mortality. cUTI infections place an economic burden on hospitals and payers.5,6
ZEMDRI is an aminoglycoside with once-daily dosing that has activity against certain Enterobacteriaceae. Achaogen's EPIC clinical trial successfully evaluated the safety and efficacy of ZEMDRI in adult patients with cUTI, including pyelonephritis. ZEMDRI was engineered to overcome aminoglycoside-modifying enzymes, the most common aminoglycoside-resistance mechanism in Enterobacteriaceae, and has in vitro activity against ESBL- producing, aminoglycoside- resistant, and carbapenem- resistant isolates. The Centers for Disease Control and Prevention has characterized ESBL- producing Enterobacteriaceae as a “serious threat” and carbapenem-resistant Enterobacteriaceae (CRE) as “nightmare bacteria,” which is an immediate public health threat that requires urgent and aggressive action.
Indications & Usage
ZEMDRI is indicated in patients 18 years of age or older for the treatment of complicated urinary tract infections (cUTI), including pyelonephritis caused by the following susceptible microorganism(s): Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis and Enterobacter cloacae.
As only limited clinical safety and efficacy data for ZEMDRI are currently available, reserve ZEMDRI for use in cUTI patients who have limited or no alternative treatment options.
To reduce the development of drug-resistant bacteria and maintain effectiveness of ZEMDRI and other antibacterial drugs, ZEMDRI should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible microorganisms.
Important Safety Information
BOXED WARNINGS: NEPHROTOXICITY, OTOTOXICITY, NEUROMUSCULAR BLOCKADE AND FETAL HARM
Contraindications: ZEMDRI is contraindicated in patients with known hypersensitivity to any aminoglycoside.
Additional Warnings and Precautions
Please click here to see the full Prescribing Information, including BOXED WARNINGS, for additional Important Safety Information.
You may report side effects to the FDA at (800) FDA-1088 or www.fda.gov/medwatch. You may also report side effects to Achaogen at (833) AKAO-402.
Achaogen is a biopharmaceutical company passionately committed to the discovery, development, and commercialization of innovative antibacterial treatments for MDR gram-negative infections. Achaogen's first commercial product is ZEMDRI, for the treatment of adults with complicated urinary tract infections (cUTI), including pyelonephritis. The Achaogen ZEMDRI program was funded in part with federal funds from the Biomedical Advanced Research and Development Authority (BARDA). The Company is currently developing C-Scape, an orally-administered beta-lactam/beta-lactamase inhibitor combination, which is also supported by BARDA. C-Scape is investigational, has not been determined to be safe or efficacious, and has not been approved for commercialization. For more information, visit the Achaogen website at www.achaogen.com.
This press release contains forward-looking statements. All statements other than statements of historical facts contained herein are forward-looking statements reflecting the current beliefs and expectations of management made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, including, but not limited to, the potential uses and advantages of ZEMDRI, Achaogen’s commercial objectives and the Achaogen pipeline of product candidates. Such forward-looking statements involve known and unknown risks, uncertainties, and other important factors that may cause Achaogen's actual results, performance, or achievements to be materially different from any future results, performance, or achievements expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, the risks and uncertainties of the regulatory approval process; market size and growth; timing of activities, including launch dates of products; statements about the efficacy, safety and tolerability of ZEMDRI and product candidates; the risks and uncertainties of product sales; the risk of when bacteria will evolve resistance to ZEMDRI and product candidates; Achaogen's reliance on third-party contract manufacturing organizations for manufacture and supply, including sources of certain raw materials; risk of third-party claims alleging infringement of patents and proprietary rights or seeking to invalidate Achaogen's patents or proprietary rights; and the risk that Achaogen's proprietary rights may be insufficient to protect its technologies and product candidates. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to the Achaogen business in general, see Achaogen current and future reports filed with the Securities and Exchange Commission, including its Annual Report on Form 10-K filed on February 27, 2018, and its Quarterly Report on Form 10-Q filed on November 8, 2018. Achaogen does not plan to publicly update or revise any forward-looking statements contained in this press release, whether as a result of any new information, future events, changed circumstances, or otherwise.
1 Wagenlehner FME, Cloutier DJ, Komirenko AS, et al. Once-Daily Plazomicin for Complicated Urinary Tract Infections. N Engl J Med 2019;380:729-40.
2 Nicolle LE. J Infect Dis. 2001;183(Suppl 1):S5-8.
3 U.S. Food & Drug. Complicated Urinary Tract Infections: Developing Drugs for Treatment Guidance for Industry. https://www.fda.gov/downloads/Drugs/Guidances/ucm070981.pdf. Accessed June 25, 2018.
4 Decision Resources Disease Landscape & Forecast, Hospital-Treated Gram-Negative Infections, September 2017; data on file.
5 Bader MS et al. Postgrad Med. 2010;122(6):7-15.
6 Turner RM et al. Clin Ther. 2015;37(9):2037-2047.
Source: Achaogen, Inc.
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