Achaogen
Jun 11, 2018

Achaogen Highlights Multiple Plazomicin Presentations at ASM Microbe 2018 Annual Meeting

SOUTH SAN FRANCISCO, Calif., June 11, 2018 (GLOBE NEWSWIRE) -- Achaogen, Inc. (NASDAQ:AKAO), a late-stage biopharmaceutical company developing innovative antibacterials addressing multi-drug resistant (MDR) gram-negative infections, today announced data highlights from five presentations on plazomicin, the Company's lead product candidate, for the treatment of serious bacterial infections due to MDR Enterobacteriaceae. The presentations took place at ASM Microbe 2018 being held in Atlanta, Georgia from June 7 to 11, 2018. The presentations are summarized as follows:

Pharmacokinetic-Pharmacodynamic (PK-PD) Target Attainment Analyses to Support Plazomicin Dose Selection and Recommendations for Interpretive Criteria for In Vitro Susceptibility Testing for Enterobacteriaceae (ENT) (Poster 518)
S. M. Bhavnani, J. P. Hammel, M. Trang, A. Kim, K. M. Krause, M. Castanheira, C. M. Rubino, P. G. Ambrose
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).

Population Pharmacokinetic Analyses for Plazomicin Using Pooled Data from Phase 1, 2 and 3 Studies (Poster Talk 3, Poster 516)
M. Trang, J. Seroogy, S. A. Van Wart, S. M. Bhavnani, A. Kim, P. G. Ambrose, C. M. Rubino
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).

Activity of Plazomicin and Comparator Agents Tested against Contemporary Clinical Isolates Collected Worldwide (Poster 645)
M. Castanheira, J. M. Streit, S. Arends, R. K. Flamm
The authors evaluated the activity of plazomicin and comparator agents against thousands of clinical isolates collected worldwide during 2017. These data confirm the activity of plazomicin against contemporary Enterobacteriaceae clinical isolates collected worldwide, including most carbapenem-resistant Enterobacteriaceae (CRE) isolates.

Evaluation of Plazomicin (PLZ), Tigecycline (TGC), and Meropenem (MEM) Pharmacodynamic (PD) Exposure against Carbapenem-Resistant Enterobacteriaceae (CRE) in Evaluable Patients from the CARE Study (ACHN-490-007) (Poster 646)
J. L. Kuti, A. Kim, D. J. Cloutier, D. P. Nicolau
The authors evaluated the pharmacodynamic exposures of plazomicin and combination agents, meropenem and tigecycline, from patients in the CARE study who received plazomicin in combination with either TGC or MEM. The pharmacodynamic exposure was achieved for PLZ in all evaluable patients but was not consistently achieved for either TGC or MEM in patients with life-threatening CRE infections. Rates of microbiological eradication and clinical response were high in plazomicin-treated patients, regardless of whether or not adequate exposure of TGC or MEM was achieved.

A Multi-Site Study Comparing a Commercially Prepared Dried MIC Susceptibility System to the CLSI/ISO Broth Microdilution Method for Plazomicin Using Non-Fastidious Gram-Negative Organisms (Poster 236)
S. M. Andrus, C. C. Knapp, N. M. Holliday, S. B. Killian, J. M. Lindley, J. M. Streit, B. J. Olson, T. R. Fritsche, J.W. Decousser, E. Scopes, A. M. Leonte, A. W. Serio
Antibiotic susceptibility testing (AST) confirms antibiotic susceptibility to specific organisms. In this study, the authors demonstrated that the Sensititre system is an acceptable method for susceptibility testing of plazomicin in the laboratory when compared to the reference standard of broth microdilution method.

The posters are available on the Achaogen website.

About Achaogen
Achaogen is a late-stage biopharmaceutical company passionately committed to the discovery, development, and commercialization of innovative antibacterial treatments for MDR gram-negative infections. Achaogen is developing plazomicin, its lead product candidate, for the treatment of serious bacterial infections due to MDR Enterobacteriaceae, including carbapenem-resistant Enterobacteriaceae. Achaogen's plazomicin program has been funded in part with federal funds from the Biomedical Advanced Research and Development Authority (BARDA), Office of the Assistant Secretary for Preparedness and Response, Office of the Secretary, Department of Health and Human Services, under Contract No. HHSO100201000046C. The Company's second product candidate C-Scape, an orally-administered beta-lactam/beta-lactamase inhibitor combination, is funded in part with federal funds from BARDA. Achaogen has other programs in early and late preclinical stages of development focused on MDR gram-negative infections and additional disease areas. All product candidates, including plazomicin, are investigational and have not been approved for commercialization. For more information, please visit www.achaogen.com

Forward-Looking Statements
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, Achaogen's expectations regarding potential regulatory approval of its product candidates and Achaogen's commercial objectives. 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.  Such risks and uncertainties include, among others, the uncertainties inherent in the preclinical and clinical development process and the risks and uncertainties of the regulatory approval process. 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 Achaogen's business in general, see Achaogen's 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 May 7, 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.

          
Investor Contact:        Media Contact:
Ashley R. Robinson        Denise T. Powell
LifeSci Partners, LLC        Red House Consulting, LLC
arr@lifesciadvisors.com         dpowell@achaogen.com