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SOUTH SAN FRANCISCO, Calif., Sept. 04, 2018 (GLOBE NEWSWIRE) -- Achaogen, Inc. (NASDAQ: AKAO), a biopharmaceutical company developing innovative antibacterials addressing multi-drug resistant (MDR) gram-negative infections, today highlighted four poster presentations about plazomicin at the ESCMID/ASM Conference on Drug Development to Meet the Challenge of Antimicrobial Resistance that is being held from September 4 to 7, 2018 in Lisbon, Portugal. The presentations are summarized as follows:
Assessment of AUC-Based Therapeutic Drug Management (TDM) Algorithms for Plazomicin Therapy in Patients with Bloodstream Infection (BSI), Trang et al. (Poster 84)
Pharmacokinetic variability in critically ill patients with serious bacterial infections is a known issue. Modeling and simulations using data from the subset of Phase 3 CARE trial patients with BSI due to carbapenem-resistant Enterobacteriaceae (CRE) suggest that, relative to dosing based on baseline renal function alone, using an Area Under the Curve (AUC)-based TDM approach may result in a higher percentage of exposures within the targeted AUC range.
Pharmacokinetics-Pharmacodynamics (PK-PD) of Plazomicin (PLZ) against Carbapenem-Resistant Enterobacteriaceae (CRE) in Neutropenic Murine Thigh Infection and Pneumonia Models, Louie et al. (Poster 100)
The authors analyzed data from murine infection models to identify the pharmacodynamic index and exposure intensity associated with optimized killing of CRE. The results suggest that exposures associated with a 15 mg/kg once daily dose in patients is suitable for treating CRE with a minimum inhibitory concentration (MIC) breakpoint of 4 mg/L.
Encore Presentation: Population Pharmacokinetic Analyses for Plazomicin Using Pooled Data from Phase 1, 2 and 3 Studies, Trang et al. (Poster 86)
The authors developed a population pharmacokinetic model for conducting simulations and generating individual estimates of drug exposure for use in pharmacokinetic-pharmacodynamic analyses (PK-PD).
Encore Presentation: Pharmacokinetic-Pharmacodynamic Target Attainment Analyses to Support Plazomicin Dose Selection and Recommendations for Interpretive Criteria for In Vitro Susceptibility Testing for Enterobacteriaceae, Bhavnani et al. (Poster 85)
The authors concluded that the total-drug plasma AUC values associated with the plazomicin clinical dose achieved ≥90% probability of target attainment across the plazomicin MIC distribution for Enterobacteriaceae in patients with complicated urinary tract infections (cUTI), including acute pyelonephritis (AP), bloodstream infection (BSI), or hospital-acquired bacterial pneumonia (HABP)/ventilator-associated bacterial pneumonia (VABP).
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 ZEMDRITM (plazomicin), 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. Achaogen is also developing a new aminoglycoside program, which is supported by CARB-X. All product candidates are investigational, have not been determined to be safe or efficacious, and have 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 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. 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 August 6, 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.
Source: Achaogen, Inc.
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