Achaogen Highlights Plazomicin Presentations at European Congress of Clinical Microbiology and Infectious Diseases (ECCMID)


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April 23, 2018 at 8:01 AM EDT

Achaogen Highlights Plazomicin Presentations at European Congress of Clinical Microbiology and Infectious Diseases (ECCMID)

-- Study findings support the potential for plazomicin to address difficult-to-treat infections, including those caused by carbapenem-resistant Enterobacteriaceae --

SOUTH SAN FRANCISCO, Calif., April 23, 2018 (GLOBE NEWSWIRE) -- Achaogen, Inc. (NASDAQ:AKAO), a late-stage biopharmaceutical company developing innovative antibacterials addressing multi-drug resistant (MDR) gram-negative infections, today highlighted presentations on its product candidate plazomicin at the 28th European Congress of Clinical Microbiology and Infectious Disease (ECCMID) that is being held from April 21 to 24, 2018 in Madrid, Spain.

The four presentations are summarized as follows:

Plazomicin is Associated with Fewer Post-Baseline Infectious Complications Compared with Colistin in Patients with Serious Infections due to Carbapenem-Resistant Enterobacteriaceae (CRE): Results from the Randomized, Controlled CARE Study (Poster P0284)
Session: PS018: Clinical trial experience - new antibacterial agents
K.Pontikis, A.Skiada, A.W.Serio, A.Smith, L.E.Connolly

Data from the CARE study highlight the potential benefit of plazomicin compared with colistin. Plazomicin was associated with higher microbiological response rates and a reduced incidence of superinfections or new infections relative to colistin. There was no emergence of resistance or decreased susceptibility to plazomicin that was observed among plazomicin-treated patients, whereas two colistin-treated patients had their baseline CRE pathogen develop resistance to colistin during therapy associated with persistent bacteremia and clinical failure at end of therapy.

The lead author, Konstantinos Pontikis, M.D., Ph.D., Sotiria General and Chest Diseases Hospital, University of Athens, Greece commented, "Carbapenem-resistant Enterobacteriaceae are a family of bacteria that are extremely difficult to treat because they are often resistant to multiple classes of antibiotics. They primarily lead to infections in patients on ventilators or those with indwelling bladder catheters or intravenous catheters. In the European Union, infections due to CRE have been associated with higher healthcare costs, prolonged hospital stays, treatment failures and mortality."

Plazomicin versus Meropenem for the Treatment of Complicated Urinary Tract Infection (cUTI): An Analysis by Complicating Factor in the EPIC Study (Mini Oral O0419)
Session: OF081 - Snapshot on pre-registration clinical trials
M.Nowicki, D.J.Cloutier, A.S.Komirenko, D.S.Cebrik, L.E.Connolly, G.D.Radavoi, V.Jinga

The authors provided a detailed description of the baseline urological complications in patients with cUTI and the microbiological eradication rates at the test-of-cure visit by complicating factor. Plazomicin demonstrated higher microbiological eradication rates relative to meropenem across all of the pre-specified complicating factors.

Plazomicin Activity Against Enterobacteriaceae Collected from Europe, Latin America, and Asia-Pacific during 2016, Including Those with Aminoglycoside and Beta-Lactam Resistance Mechanisms (Poster P0093)
Session: PS006: Activity of new or re-purposed non-beta-lactam drugs against Gram-negatives
M.Castanheira, R.E.Mendes, T.B.Doyle, J.M.Streit, A.W.Serio, K.M.Krause, R.K.Flamm

This in vitro study documented plazomicin activity against Enterobacteriaceae isolates collected from Europe, Latin America and Asia-Pacific during 2016 with an MIC50/MIC90 of 0.5/1 mg/L. Plazomicin was active against isolates with genes encoding extended-spectrum beta-lactamases, carbapenemases and aminoglycoside modifying enzymes. 

In Vitro Activity of Plazomicin Against Klebsiella spp. Blood Isolates (Poster P0095)
Session: PS006: Activity of new or re-purposed non-beta-lactam drugs against Gram-negatives
D.Gür, Ü.Liste, S.Nigiz, A.Cakar, B.Altun, B.Sancak

This in vitro study documented plazomicin activity against Klebsiella spp. blood isolates collected from patients at one hospital in Turkey between 2016-2017, including a large subset of ceftazidime-resistant isolates, with an MIC50/MIC90 of 0.25/1 mg/L. 

The abstracts can be accessed through the ECCMID website. The presentation slides and posters are available on the Achaogen website.

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, its lead product candidate, for the treatment of serious bacterial infections due to MDR Enterobacteriaceae, including carbapenem-resistant Enterobacteriaceae. The Food and Drug Administration has granted plazomicin Breakthrough Therapy designation for the treatment of bloodstream infections caused by certain Enterobacteriaceae in patients who have limited or no alternative treatment options. Achaogen's plazomicin program has been 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. The Company's second product candidate C-Scape, an orally-administered beta-lactam/beta-lactamase inhibitor combination, is funded in part with federal funds from BARDA. Achaogen has other programs in early and late preclinical stages of development focused on MDR gram-negative infections and additional disease areas. All product candidates, including plazomicin, are investigational 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 and other product candidates, and Achaogen's pipeline. 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. 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 filed on February 27, 2018. 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.

Investor Contact: Media Contact:
Ashley R. Robinson   Denise T. Powell
LifeSci Partners, LLC   Red House Consulting, LLC
arr@lifesciadvisors.com   dpowell@achaogen.com