-- Clinical trial to evaluate orally-administered beta-lactam/beta-lactamase inhibitor combination being developed for infections due to extended spectrum beta-lactamase (ESBL)-producing Enterobacteriaceae --
-- Initiation of pivotal Phase 3 clinical trial in patients with complicated urinary tract infections (cUTI) planned for first half of 2018 --
SOUTH SAN FRANCISCO, Calif., June 01, 2017 (GLOBE NEWSWIRE) -- Achaogen, Inc. (NASDAQ:AKAO), a late-stage biopharmaceutical company developing innovative antibacterials addressing multi-drug resistant (MDR) gram-negative infections, today announced that it has dosed the first patient with C-Scape in a Phase 1 clinical pharmacology, dosing and safety study. C-Scape, a combination of an approved beta-lactam and an approved beta-lactamase inhibitor, is the Company’s second antibacterial candidate being developed for MDR gram-negative infections.
“The lack of effective oral antibiotic options for infections due to ESBL-producing Enterobacteriaceae often requires treatment with intravenous therapy in the hospital,” said Kenneth Hillan, M.B. Ch.B., Achaogen's Chief Executive Officer. “We believe that C-Scape offers the potential for a much-needed oral therapy to effectively treat infections due to ESBL-producing Enterobacteriaceae.”
With the C-Scape program, Achaogen plans for a rapid development and regulatory approach that leverages a 505(b)(2) path that, if the Phase 1 is successful, supports the initiation of a single pivotal Phase 3 trial in the first half of 2018. C-Scape has been awarded Qualified Infectious Disease Product (QIDP) status by FDA for the treatment of cUTI, including acute pyelonephritis (AP). QIDP designation provides incentives for new antibiotic treatments, including priority review and additional market exclusivity. The Company’s preclinical studies have confirmed C-Scape’s potent in vitro microbiologic activity against ESBL-producing Enterobacteriaceae and its potential to achieve efficacious exposures with an oral dosing regimen.
About the Clinical Trial
This Phase 1 clinical trial is a double-blind, randomized, placebo-controlled, parallel group study to assess the safety, tolerability and clinical pharmacology of C-Scape (ACHN-383 and ACHN-789), administered orally, in healthy subjects with and without renal impairment. Healthy subjects with moderate to severe renal impairment are being included because, in practice, renal impairment is a common comorbidity in patients with cUTI due to MDR pathogens including ESBL-producing Escherichia coli and Klebsiella pneumoniae.
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, 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. All product candidates are investigational only 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 plazomicin, Achaogen’s commercial objectives and Achaogen’s 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 uncertainties inherent in the preclinical and clinical development process; the risks and uncertainties of the regulatory approval process; the risks and uncertainties of commercialization and gaining market acceptance; the risk when bacteria will evolve resistance to plazomicin; 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; 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 Annual Report on Form 10-K for the fiscal year ended December 31, 2016, filed on March 14, 2017. 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.