-- Plazomicin NDA submission planned for the second half of 2017 --
-- Plan to initiate clinical trial of orally-administered antibacterial candidate for ESBL+ infections, C-Scape, in 2017 --
-- Advances in research expand unique pipeline of therapeutic candidates targeting the most critical priority pathogens --
SOUTH SAN FRANCISCO, Calif., March 01, 2017 (GLOBE NEWSWIRE) -- Achaogen, Inc. (NASDAQ:AKAO), a late-stage biopharmaceutical company discovering and developing innovative antibacterials addressing multi-drug resistant (MDR) gram-negative infections, held an R&D Day to provide an overview of its Research and Development programs including the Company's new orally-administered antibacterial candidate, C-Scape. The meeting consisted of presentations from members of Achaogen’s leadership team and medical community key opinion leaders.
"We aspire to solve the growing issue of antimicrobial resistance and we are very pleased to announce that we now have two potential development candidates to further this vision,” said Kenneth Hillan, M.B. Ch.B., Achaogen's Chief Executive Officer. "We believe that with plazomicin, a pre-NDA candidate, and C-Scape, a 2017 Phase 1 candidate with potential for rapid development, we are positioned to advance our leadership in discovering, developing, and commercializing innovative antibacterials to treat the critical priority pathogens that cause highly resistant gram-negative infections.”
The Achaogen R&D Day focused on the Company's antibacterial development pipeline to support the following corporate objectives:
- Prepare for potential Food and Drug Administration (FDA) approval and product launch of plazomicin;
- Initiate clinical development of C-Scape, the Company’s orally-administered beta-lactam/beta-lactamase inhibitor combination; and
- Continue to advance novel research candidates for serious unmet needs, including infections caused by MDR pathogens.
Plazomicin: The R&D Day provided an overview of the plazomicin program, including a review of the Phase 3 results, progress towards the planned New Drug Application (NDA) submission and preparation for commercialization:
- The positive results from Phase 3 EPIC and CARE clinical trials of plazomicin were discussed along with a perspective by Dr. Yoav Golan (Tufts Medical Center and Associate Professor of Medicine at Tufts University School of Medicine) about treating patients with MDR infections, including carbapenem-resistant Enterobacteriaceae (CRE);
- Achaogen market research conducted with treating physicians supports the clear and important need for plazomicin in CRE;
- The Company remains on track to submit an NDA to the FDA in the second half of 2017 and to submit a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) in 2018.
C-Scape: An overview of Achaogen’s newly announced, orally-available antibacterial candidate, C-Scape, a combination of an approved beta-lactam and an approved beta-lactamase inhibitor, was provided. Key highlights were as follows:
- C-Scape has the potential to treat patients with complicated urinary tract infections (cUTI) due to MDR pathogens including extended spectrum beta-lactamase (ESBL) producing Escherichia coli and Klebsiella pneumoniae, where effective oral therapeutic options are limited due to increasing antibiotic resistance. Studies confirmed:
- Potent in vitro microbiology activity against ESBL-Enterobacteriaceae and rapid bactericidal activity in time-kill experiments
- Potential to achieve efficacious exposures with an oral three times daily dosing regimen
- C-Scape awarded qualified infectious disease product (QIDP) status by FDA for the treatment of cUTI, including acute pyelonephritis, in January 2017. QIDP designation provides incentives for new antibiotics, including priority review and additional market exclusivity; and
- Achaogen currently projecting to commence Phase 1 C-Scape clinical development in the second quarter of 2017 and, if successful, to proceed to pivotal Phase 3 cUTI trial initiation in the first half of 2018.
Research Discovery and Development: Achaogen’s research and early development overview focused on novel approaches to address infections caused by MDR gram-negative pathogens. The early stage pipeline consists of the following research candidates:
- LpxC program: currently on track to file an Investigational New Drug (IND) application as early as 2018 with a compound that has shown potent activity against Pseudomonas aeruginosa;
- Aminoglycoside program: novel aminoglycoside candidates with broad spectrum activity against MDR gram-negative bacteria including Pseudomonas aeruginosa and Acinetobacter baumannii;
- Bactericidal monoclonal antibody program: The Company’s antibody discovery platform aims to generate antibodies that treat infections caused by MDR gram-negative pathogens by disrupting bacterial outer membrane biogenesis, culminating in bacterial cell death;
- The antibody discovery platform, which leverages microfluidics, our proprietary bacterial stress reporter technology, and single B cell antibody cloning enables us to rapidly screen millions of individual B cells for the production of functional bactericidal antibodies. Our initial focus is on identifying bactericidal monoclonal antibodies against Acinetobacter baumannii.
- Other monoclonal antibodies: The Company has identified key human targets that drive the pathogenesis of diseases associated with high unmet medical needs. We are using a humanized chicken antibody platform to identify functional antibodies that bind to epitopes that have been unexploited by previous antibody discovery efforts. One such antibody program is focused on antibodies that specifically and potently inhibit NaV1.7 as a potential non-opioid treatment for pain.
An audio webcast of the 2017 Achaogen R&D Day is available in the "Investors" section of Achaogen’s website, www.achaogen.com. A replay of the presentation will be available until April 2, 2017.
About Achaogen
Achaogen is a late-stage biopharmaceutical company passionately committed to the discovery, development, and commercialization of innovative 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 (BARDA), 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 an orally-available antibacterial candidate, C-Scape, a combination of an approved beta-lactam and an approved beta-lactamase inhibitor. Achaogen is also pursuing an advanced series of LpxC inhibitor compounds that are active against Pseudomonas aeruginosa, and have been funded in part with Federal funds from the National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health, Department of Health and Human Services, under Contract No. HHSN272201500009C. 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; risks and uncertainties related to the acceptance of government funding for certain of Achaogen's programs, including the risk that BARDA or NIAID could terminate Achaogen's contract for the funding of the plazomicin or LpxC inhibitor development programs, respectively; 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 September 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.
Source: Achaogen, Inc.
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