— Presentations emphasize potential role for plazomicin in treating bloodstream infections (BSI) due to carbapenem-resistant Enterobacteriaceae (CRE) as well as potential long-term clinical benefits for patients with complicated urinary tract infections (cUTI) and acute pyelonephritis (AP) —
SOUTH SAN FRANCISCO, Calif., Oct. 05, 2017 (GLOBE NEWSWIRE) — Achaogen, Inc. (NASDAQ:AKAO), a late-stage biopharmaceutical company developing innovative antibacterials addressing multidrug-resistant (MDR) gram-negative infections, today summarized five plazomicin presentations at the Infectious Diseases Society of America (IDSA) IDWeek™ 2017, being held in San Diego, CA from October 4 to 8, 2017.
Findings further supplement the evidence that plazomicin may have a unique role in addressing difficult-to-treat infections, including those caused by carbapenem-resistant Enterobacteriaceae. Poster presentations that are taking place on Saturday, October 7, 2017, are summarized as follows:
Improved Outcomes with Plazomicin (PLZ) Compared with Colistin (CST) in Patients with Bloodstream Infections (BSI) Caused by Carbapenem-resistant Enterobacteriaceae (CRE): Results from the CARE Study
Poster abstract #1853, Session: Clinical Study with New Antibiotics and Antifungals
J.McKinnell, L.Connolly, R.Pushkin, A.Jubb, B.O’Keeffe, A.Serio, A.Smith, J.Gall, V.Riddle, K.Krause, J.Pogue
This poster demonstrates that plazomicin was associated with improved survival and a higher microbiological response rate compared with colistin in patients with bloodstream infections (BSI) caused by CRE. The data suggest that improved outcomes could be due to earlier and more sustained blood clearance of the bacteria by plazomicin compared to colistin. In terms of key safety outcomes, plazomicin was associated with a lower incidence and magnitude of serum creatinine increases compared to colistin.
Improved Outcomes at Late Follow-up (LFU) with Plazomicin Compared with Meropenem in Patients with Complicated Urinary Tract Infection (cUTI) or Acute Pyelonephritis (AP) in the EPIC Study
Poster abstract #1859, Session: Clinical Study with New Antibiotics and Antifungals
Y.Golan, D.Cloutier, A.Komirenko, D.Cebrik, T.Keepers, K.Krause, L.Connolly, F.Wagenlehner
This poster demonstrates a significantly higher composite cure rate at the late follow-up visit for plazomicin compared with meropenem, a higher incidence of clinical relapse in meropenem treated patients and that most relapses occurred in patients with asymptomatic bacteriuria at the prior test-of-cure visit. The authors highlight the sustained and differentiated microbiological effect of plazomicin, compared with meropenem, and suggest that plazomicin treatment may confer a long-term clinical benefit for patients with cUTI and AP.
Plazomicin Versus Meropenem for Complicated Urinary Tract Infection (cUTI) and Acute Pyelonephritis (AP): Diagnosis-specific Results from the Phase 3 EPIC Study
Poster abstract #1855, Session: Clinical Study with New Antibiotics and Antifungals
D.Cloutier, A.Komirenko, D.Cebrik, T.Keepers, K.Krause, L.Connolly, F.Wagenlehner
This poster highlights the efficacy and safety of plazomicin compared with meropenem in the subsets of patients with cUTI or AP. Plazomicin demonstrated higher microbiological eradication rates for both diagnoses (cUTI and AP) at the test-of-cure visit than meropenem, a preferred agent for treatment of infections due to MDR Enterobacteriaceae. The overall incidence of adverse events (AEs), serious AEs, and AEs leading to discontinuation of intravenous study drug was comparable between treatment arms and across diagnoses. The results support plazomicin as a potential treatment option for cUTI and AP.
The following poster presentations will take place on Friday, October 6, 2017:
Assessment of the In Vivo Efficacy of Plazomicin (PLZ) Alone or in Combination with Meropenem (MEM) or Tigecycline (TGC) against Enterobacteriaceae (EB) Isolates Exhibiting Various Resistance Mechanisms in an Immunocompetent (I+) Murine Septicemia Model
Poster abstract #1506, Session: Preclinical Study with New Antibiotics and Antifungals
K. Abdelraouf, A.Kim, K.Krause, D.Nicolau
The objective of this preclinical study was to assess the efficacy of human simulated exposures of plazomicin in a mouse model of septicemia. Plazomicin monotherapy led to substantial improvements in 96-hour survival for mice infected with isolates with plazomicin MICs <8 mcg/mL. Overall, plazomicin monotherapy led to rapid clearance of bacteremia (within 4 hours) in mice. Utilizing clinically relevant exposures, these data support a potential role for plazomicin in the management of bloodstream infection and septicemia due to Enterobacteriaceae, including carbapenem-resistant isolates.
Activity of Plazomicin against Enterobacteriaceae Isolates Collected in the United States Including Isolates Carrying Aminoglycoside-Modifying Enzymes Detected by Whole Genome Sequencing
Poster abstract #1235, Session: Expanded Spectrum – New Antimicrobial Susceptibility Testing
M.Castanheira, L.Deshpande, C.Hubler, R.Mendes, A.Serio, K.Krause, R.Flamm
Authors highlight the potent activity of plazomicin against 2,097 clinical isolates, regardless of infection type, collected during a 2016 U.S. Surveillance Program, including isolates resistant to other aminoglycosides and CRE. Additionally, this study provides an analysis of the molecular epidemiology of aminoglycoside resistance in the United States, as well as an update on the spectrum of plazomicin activity against contemporary clinical isolates.
All posters being presented by Achaogen or their collaborators will be available on the Achaogen website at www.achaogen.com.
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 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. HHSO100201000046C. The Company’s second product candidate is C-Scape, an orally-administered beta-lactam/beta-lactamase inhibitor combination. Achaogen has other programs in early and late preclinical stages focused on other MDR gram-negative infections and additional disease areas. All product candidates, including plazomicin, 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 filed on March 14, 2017 and its Quarterly Report on Form 10-Q for the quarter ended June 30, 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.
Contacts:
David Arrington, Media
Vice President, Investor Relations and Corporate Communications
650.440.5856
darrington@achaogen.com
Ashley Robinson, Investors
617-775-5956
arr@lifesciadvisors.com
