SOUTH SAN FRANCISCO, Calif., June 02, 2016 (GLOBE NEWSWIRE) -- Achaogen, Inc. (NASDAQ:AKAO), a clinical-stage
biopharmaceutical company developing novel antibacterials addressing multi-drug resistant (MDR) gram-negative infections, today
announced that it has achieved over 50 percent patient enrollment in its ongoing Phase 3 EPIC registration clinical trial of
plazomicin. Achaogen is developing plazomicin, its lead product candidate, to treat serious bacterial infections due to MDR
Enterobacteriaceae, including carbapenem-resistant Enterobacteriaceae (CRE).
"Enrollment in the EPIC clinical trial has been progressing well and we are pleased that we have enrolled half of the
approximately 530 patients that we intend to recruit for the trial," said Kenneth Hillan, Achaogen's Chief Executive Officer. "We
look forward to completing enrollment in the EPIC trial this year and expect to report top-line data in first quarter of 2017.”
EPIC (Evaluating plazomicin in cUTI) is a multi-national,
randomized, controlled, double-blind clinical trial in patients with complicated urinary tract infections (cUTI), including acute
pyelonephritis (AP), which is expected to create a substantial opportunity for plazomicin to address the unmet medical need arising
from multi-drug resistant (MDR) infections. The EPIC trial is expected to serve as a single pivotal trial and support a New Drug
Application (NDA) submission in the second half of 2017. The Company also expects to announce top-line results for the CARE
(Combating Antibiotic Resistant Enterobacteriaceae) study, a
Phase 3 clinical trial in patients with serious bacterial infections due to CRE, in the first half of 2017.
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 a contract from the Biomedical Advanced Research and
Development Authority. Plazomicin is the first clinical candidate from Achaogen’s gram-negative antibiotic discovery engine, and
Achaogen has other programs in early and late preclinical stages focused on other MDR gram-negative infections. 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 timeline for enrollment of Achaogen’s ongoing Phase 3 EPIC trial and Phase 3 CARE trial, (ii) the expectation
that the Phase 3 EPIC trial will serve as a single pivotal trial supporting an NDA for plazomicin, and (iii) the timing for
completion of Achaogen’s Phase 3 trials and submission of an NDA to the U.S. Food and Drug Administration. 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; specific risks related to the ongoing Phase 3 EPIC trial and Phase 3 CARE trial, including the
lack of a prior clinical trial in patients with CRE infections and challenges in enrolling an adequate number of patients with rare
infections; 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 March 31, 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.
Investor Contact: Hans Vitzthum 212.915.2568 hans@lifesciadvisors.com Media Contact: Denise Powell 510.703.9491 denise@redhousecomms.com
