Achaogen Awarded Up To $18 Million Contract By BARDA To Support Development Of Orally-Administered Antibacterial Candidate C-Scape
Published: Sep 28, 2017
Non-dilutive funding to support clinical development of antibacterial candidate for ESBL infections
Company expects top-line Phase 1 results in 2017 and initiation of pivotal Phase 3 trial in 2018
SOUTH SAN FRANCISCO, Calif., Sept. 28, 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 been awarded a contract valued at up to $18 million in funding from the Biomedical Advanced Research and Development Authority (BARDA) to support the development of C-Scape, a product candidate being developed to treat serious bacterial infections due to extended spectrum beta-lactamase (ESBL)-producing Enterobacteriaceae. The BARDA contract (Contract No. HHSO100201700021C) was awarded to Achaogen under BARDA’s Antibacterials program, and includes a nine-month base period with committed funding of $12 million and subsequent option periods that, if exercised, would bring the total value of the award to $18 million.
“We are extremely grateful for BARDA’s support, and validation, of our C-Scape program as we advance this unique candidate through a streamlined development approach with an aim of initiating a pivotal Phase 3 trial next year,” 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, and we look forward to continuing to work with BARDA as they provide critical leadership in the effort to combat multi-drug resistance.”
About the C-Scape Program
Achaogen is conducting a Phase 1 clinical trial to assess the safety, tolerability and clinical pharmacology of C-Scape, administered orally in healthy subjects with and without renal impairment. Achaogen plans for a streamlined development approach that leverages a 505(b)(2) path for C-Scape that, if the Phase 1 is successful, supports the initiation of a pivotal Phase 3 trial in 2018. C-Scape has been awarded Qualified Infectious Disease Product (QIDP) status by FDA for the treatment of cUTI, including acute pyelonephritis (AP). 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.
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’s C-Scape 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. HHSO100201700021C. Achaogen is also developing plazomicin for the treatment of serious bacterial infections due to MDR Enterobacteriaceae, including carbapenem-resistant Enterobacteriaceae. FDA has granted plazomicin Breakthrough Therapy designation for the treatment of bloodstream infections (BSI) caused by certain Enterobacteriaceae in patients who have limited or no alternative treatment options. Achaogen's plazomicin program is funded in part with a contract from the Biomedical Advanced Research and Development Authority. 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.
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; 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 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 Annual Report on Form 10-K for the fiscal year ended December 31, 2016, filed on March 14, 2017 and its Quarterly Reports on Form 10-Q, including the report for the fiscal quarter ended June 30, 2017, filed on August 3, 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.
Source: Achaogen, Inc.