Achaogen to Present First Plazomicin CARE Trial Data in Patients with Carbapenem-Resistant Enterobacteriaceae (CRE) infections at IDWeek 2016

-- CARE trial clinical data highlight the contribution of therapeutic drug management in guiding targeted dosing of plazomicin in critically ill patients with antibiotic resistant gram-negative infections --

-- Plazomicin displayed potent in vitro activity against clinical isolates collected in 2015 U.S. Surveillance analysis; plazomicin was the most active aminoglycoside tested against CRE --

SOUTH SAN FRANCISCO, Calif., Oct. 24, 2016 -- Achaogen, Inc. (NASDAQ:AKAO), a clinical-stage biopharmaceutical company developing novel antibacterials addressing multi-drug resistant (MDR) gram-negative infections, today announced multiple data presentations from its plazomicin program at the Infectious Diseases Society of America (IDSA) IDWeek™ 2016, being held in New Orleans, LA, from October 26 to 30, 2016. For the first time, the Company and its collaborators will present data from Cohort 2 of the CARE (Combating Antibiotic Resistant Enterobacteriaceae) trial of plazomicin, the Company’s lead product candidate.

Findings from studies, to be presented at IDWeek 2016, further supplement the evidence that plazomicin may have a role in addressing difficult-to-treat, gram-negative infections, including Carbapenem-Resistant Enterobacteriaceae (CRE). The CARE trial, a Phase 3 clinical trial in patients with serious bacterial infections due to CRE, includes a randomized cohort (Cohort 1; N=39) and a single-arm expanded eligibility cohort (Cohort 2; N=30) that includes patients with confirmed CRE. Top-line results from the CARE trial are expected to be reported, along with top-line results from the EPIC (Evaluating plazomicin in cUTI) trial, in early Q1 2017. The full CARE trial results are expected to be submitted as supportive data with the plazomicin New Drug Application (NDA) submission in the second half of 2017.

“We are pleased with the initial presentation of data from the CARE trial in critically ill patients with infections due to carbapenem-resistant Enterobacteriaceae (CRE),” said Ian Friedland, M.D., chief medical officer of Achaogen. “For the medical professions who treat these patients, it is well understood that significant pharmacokinetic variability is a broad issue for dosing drugs in these patients. Consequently, the potential to treat effectively and with limited nephrotoxicity using plazomicin and therapeutic drug management is extremely encouraging.”

The three presentations are taking place from 12:30 to 2:00 p.m. CDT on Saturday, October 29, 2016, and are summarized as follows:

Utility of Therapeutic Drug Management (TDM) in Managing Plazomicin Pharmacokinetic (PK) Variability in Patients with Infections due to Carbapenem-Resistant Enterobacteriaceae (CRE)
(Poster abstract #2049, Session: Antimicrobial Resistant Infections: Treatment)
G.Daikos, S.Zakynthinos, A.Komnos, M.Souli, E.Antoniadou, G.Vlachogianni, N.Kapravelos, A.Serio, J.Seroogy, A.Smith, A.Jubb, A.Koutsoukou, K.Pontikis, A.Skiada, E.Zakynthinos

Significant pharmacokinetic (PK) variability of many therapeutics in critically ill patients with serious bacterial infections is known to be a major issue and was also observed in the CARE trial. The authors show that plazomicin dose adjustment based on TDM was frequently required in the first 10 patients enrolled on Cohort 2 of CARE. The authors conclude that plazomicin dosing, including the use of therapeutic drug management, was not associated with significant kidney injury in these critically ill patients with CRE.

Population Pharmacokinetics (PPK) of Plazomicin and Use of Therapeutic Drug Management (TDM) in Critically Ill Patients
(Poster abstract #1974, Session: Antimicrobial Pharmacokinetics and Pharmacodynamics)
S.Van Wart, J.Seroogy, M.Trang, L.Connolly, C.Rubino, A.Jubb, S.Bhavnani, V.Riddle, T.Mizuno, A.Vinks, A.Forrest

The authors observed significant PK variability in the first 22 plazomicin-treated patients in the CARE trial (Cohorts 1 and 2). The use of TDM improved the probability that drug exposures were in the target range more often than can be achieved using standard dosing, leading the authors to suggest that individualized plazomicin dosing is needed to ensure target exposures are achieved.

Activity of Plazomicin and Comparator Agents Tested Against Gram-negative and -positive Clinical Isolates Collected in USA Hospitals During 2015
(Poster abstract #1822, Session: Antibacterial Susceptibility Surveillance)
M.Castanheira, R.Mendes, J.Streit, R.Flamm

Authors highlight the potent activity of plazomicin against 2,306 clinical isolates collected during the 2015 U.S. Surveillance Program, including isolates resistant to the other aminoglycosides and Carbapenem-Resistant Enterobacteriaceae (CRE). These data confirm previous findings and provide an update on the spectrum of plazomicin activity against contemporary clinical isolates.

All posters being presented by Achaogen or their collaborators will be available on Saturday, October 29, 2016 on the Achaogen website at www.achaogen.com.

About Achaogen
Achaogen is a clinical-stage biopharmaceutical company passionately committed to the discovery, development, and commercialization of novel antibacterials to treat MDR gram-negative infections. Achaogen is developing plazomicin, Achaogen’s lead product candidate, for the treatment of serious bacterial infections due to MDR Enterobacteriaceae, including carbapenem-resistant Enterobacteriaceae. Achaogen’s plazomicin program is funded in part with Federal funds from the Biomedical Advanced Research and Development Authority, Office of the Assistant Secretary for Preparedness and Response, Office of the Secretary, Department of Health and Human Services, under Contract No. HHSO100201000046C. Plazomicin is the first clinical candidate from Achaogen’s gram-negative antibiotic discovery engine. Achaogen has other programs in early and late preclinical stages focused on other MDR gram-negative infections, including LpxC inhibitors for the treatment of serious bacterial infections including MDR gram-negative bacteria. Achaogen's LpxC inhibitor program has been funded in part with Federal funds from the National Institute of Allergy and Infectious Diseases, National Institutes of Health, Department of Health and Human Services, under Contract No. HHSN272201500009C. LpxC inhibitors are the second class of molecules from Achaogen's gram-negative antibiotic discovery engine. 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 (i) the timing of top-line results from the CARE trial and the EPIC trial, and (ii) whether the full CARE trial results will be submitted as supportive data with the plazomicin NDA submission in the second half of 2017. 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 uncertainties inherent in the preclinical and clinical development process; the risk of failure to successfully validate, develop and obtain regulatory clearance or approval for the in vitro diagnostic (IVD) assay for plazomicin; the risks and uncertainties of the regulatory approval process; the risks and uncertainties of commercialization and gaining market acceptance; the risk that bacteria may evolve resistance to plazomicin; risks and uncertainties as to Achaogen's ability to raise additional capital to support the development of plazomicin and its other programs; uncertainties regarding the availability of adequate third-party coverage and reimbursement for newly approved products; Achaogen's reliance on third parties to conduct certain preclinical studies and all of its clinical trials; Achaogen's reliance on third-party contract manufacturing organizations to manufacture and supply its product candidates and certain raw materials used in the production thereof; Achaogen's dependence on its President and Chief Executive Officer; risks and uncertainties related to the acceptance of government funding for certain of Achaogen's programs, including the risk that BARDA could terminate Achaogen's contract for the funding of the plazomicin development program; 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 Achaogen's business in general, see Achaogen's current and future reports filed with the Securities and Exchange Commission, including its Quarterly Report on Form 10-Q for the quarter ended June 30, 2016, and its Annual Report on Form 10-K for the fiscal year ended December 31, 2015. 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.

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