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Shionogi Announces Upcoming Presentations at American Society for Microbiology Microbe Meeting

2018年06月05日 PM09:00
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OSAKA, Japan & FLORHAM PARK, N.J.

Shionogi & Co., Ltd. (hereafter “Shionogi”) announced today that eight scientific posters will feature the company’s investigational compounds at the American Society for Microbiology (ASM) Microbe meeting in Atlanta, June 7-11, 2018.

Shionogi will present data on cefiderocol (S-649266), a late stage investigational siderophore cephalosporin with a novel mechanism of cell entry that has activity against a broad range of Gram-negative pathogens including multidrug-resistant (MDR) strains; and COT-143, an investigational humanized monoclonal antibody demonstrating anti-virulence activity targeting the PcrV protein, an essential component of the Pseudomonas aeruginosa type III secretion system.

All poster presentations will take place in the Exhibit and Poster Hall, Building B, Halls B2-B5.

The following five poster presentations will share cefiderocol findings:

  • Poster #619: Frequency of Resistance Acquisition and Resistance Mechanisms to Cefiderocol
    Presenter: Naoki Kohira
    Date and time: June 9, 2018, 11 a.m.-1 p.m.
  • Poster #620: Cefiderocol Minimum Inhibitory Concentrations (MICs) against Ceftazidime-Avibactam Susceptible and Resistant Carbapenem-Resistant Enterobacteriaceae (CRE)
    Presenter: Ryan Shields
    Date and time: June 9, 2018, 11 a.m.-1 p.m.
  • Poster #621: In Vitro Activity of Siderophore Cephalosporin Cefiderocol against YRIN(K) PBP3 Insertion-Carrying Escherichia coli
    Presenter: Takafumi Sato
    Date and time: June 9, 2018, 11 a.m.-1 p.m.
  • Poster #622: Cefiderocol (S-649266) Activity against Globally Isolated Meropenem Non-Susceptible Gram-Negative Bacteria Containing Serine- and Metallo-Carbapenemase Genes
    Presenter: Masakatsu Tsuji
    Date and time: June 9, 2018, 11 a.m.-1 p.m.
  • Poster #623: Resistance Acquisition Studies of Cefiderocol by Serial Passage and In Vitro Pharmacodynamic Model Under Human Simulated Exposure
    Presenter: Naoki Kohira
    Date and time: June 9, 2018, 11 a.m.-1 p.m.

The following poster presentations will share COT-143 findings:

  • Poster #627: Correlation between In Vitro/In Vivo Production of Pseudomonas aeruginosa PcrV Protein Isolated from Ventilator-associated Pneumonia Patients and Their Virulence in Murine Lung Infection Models
    Presenter: Hideki Maki
    Date and time: June 8, 2018, 11 a.m.-1 p.m.
  • Poster #636: COT-143, a Novel Monoclonal Antibody against the PcrV Protein: In vivo Efficacy in Combination with Antimicrobials or G-CSF against Pseudomonas aeruginosa in Murine Lung Infection Models
    Presenter: Hideki Maki
    Date and time: June 10, 2018, 0:45 p.m.-2:45 p.m.

The following poster presentation will share Gram-negative pathogens information from patients diagnosed with hospital-acquired pneumonia (HAP) or ventilator-associated pneumonia (VAP):

  • Poster #406: Non-Fermenters as Predominant Source of Carbapenem-Resistance in HAP/VAP Patients in US Hospitals between 2010 and 2015
    Presenter: Bin Cai
    Date and time: June 8, 2018, 11 a.m.-1 p.m.

All abstracts for ASM Microbe are available online here.

About cefiderocol—an investigational antibiotic agent
Cefiderocol is a siderophore cephalosporin with a novel mechanism for penetrating the outer cell membrane of Gram-negative pathogens. Cefiderocol binds to ferric iron and is actively transported into bacterial cells through the outer membrane via the bacterial iron transporters, which function to incorporate this essential nutrient for bacterial.1 This mechanism allows cefiderocol to achieve higher concentrations in the periplasmic space where it can then bind to receptors and inhibit cell wall synthesis in the bacterial cells.2 In addition, cefiderocol can also enter cells by passive diffusion through porin channels and is stable against all known classes of beta-lactamases, including both the metallo- and serine-carbapenemases.3 Data from global surveillance studies for cefiderocol demonstrated potent in vitro activity against a wide spectrum of Gram-negative pathogens including carbapenem-resistant Acinetobacter baumannii, P. aeruginosa, Enterobacteriaceae, and S. maltophilia.4 Cefiderocol has poor in vitro activity against Gram-positive or anaerobic bacteria.

Cefiderocol is currently in clinical development. Two Phase 3 studies are ongoing and enrolling patients with carbapenem-resistant pathogens at various infection sites (CREDIBLE-CR) and a HAP/VAP/HCAP clinical trial (APEKS-NP). Information is available at www.clinicaltrials.gov under the identifiers NCT02714595 and NCT03032380, respectively.

About COT-143—an investigational compound
COT-143 is a humanized monoclonal antibody that binds to the PcrV protein of P. aeruginosa. The PcrV protein is an essential component of the type III secretion system responsible for releasing harmful toxins and is related to the pathogenicity of P. aeruginosa. By using a variety of nonclinical in vitro and in vivo models, COT-143 has demonstrated the potential to reduce tissue and cellular damage by the toxins released by this system, leading to the treatment of infection caused by P. aeruginosa.

It is estimated that 51,000 healthcare-associated P. aeruginosa infections occur in the US each year and the rates of antibiotic resistance are increasing worldwide.5,6 As resistance rises there are limited options to treat or prevent P. aeruginosa infections. COT-143 is in early-stage development.

About Shionogi
Shionogi & Co., Ltd. is a Japanese major research-driven pharmaceutical company dedicated to bringing benefits to patients based on its corporate philosophy of “supplying the best possible medicine to protect the health and wellbeing of the patients we serve.” Shionogi Inc., the U.S. based subsidiary of Shionogi & Co., Ltd., continues this focus on the development and commercialization of high quality medicines that protect the health and well-being of the patients we serve. The company currently markets products in several therapeutic areas including anti-infectives, pain, cardiovascular diseases and gastroenterology. Our pipeline is focused on infectious disease, pain, CNS and oncology. For more details on Shionogi Inc., visit www.shionogi.com. For more information on Shionogi & Co., Ltd., visit www.shionogi.co.jp/en.

Forward-Looking Statements
This announcement contains forward-looking statements. These statements are based on expectations in light of the information currently available, assumptions that are subject to risks and uncertainties which could cause actual results to differ materially from these statements. Risks and uncertainties include general domestic and international economic conditions such as general industry and market conditions, and changes of interest rate and currency exchange rate. These risks and uncertainties particularly apply with respect to product-related forward-looking statements. Product risks and uncertainties include, but are not limited to, completion and discontinuation of clinical trials; obtaining regulatory approvals; claims and concerns about product safety and efficacy; technological advances; adverse outcome of important litigation; domestic and foreign healthcare reforms and changes of laws and regulations. Also for existing products, there are manufacturing and marketing risks, which include, but are not limited to, inability to build production capacity to meet demand, unavailability of raw materials and entry of competitive products. The company disclaims any intention or obligation to update or revise any forward-looking statements whether as a result of new information, future events or otherwise.

References

1.     Ito A, Nishikawa T., Masumoto S, et al. Siderophore Cephalosporin Cefiderocol Utilizes Ferric Iron Transporter Systems for Antibacterial Activity against Pseudomonas aeruginosa. Antimicrob Agents Chemother. 2016;60(12):7396-7401.
 
2. Tillotson GS. Trojan Horse Antibiotics—A Novel Way to Circumvent Gram-Negative Bacterial Resistance? Infectious Diseases: Research and Treatment. 2016;9:45-52 doi:10.4137/IDRT.S31567.
 
3. Ito-Horiyama T, Ishii Y, Ito A, et al. Stability of Novel Siderophore Cephalosporin S-649266 against Clinically Relevant Carbapenemases. Antimicrob Agents Chemother. 2016;60(7):4384-4386.
 
4.

M Hackel, M Tsuji, Y Yamano, et al. In Vitro Activity of the Siderophore Cephalosporin, Cefiderocol, Against a Recent Collection of Clinically Relevant Gram-Negative Bacilli from North America and Europe, Including Carbapenem Non-Susceptible Isolates: The SIDERO-WT-2014 Study. Antimicrobial Agents Chemotherapy. 2017;61(9): e00093-17., https://doi.org/10.1128/AAC.00093-17.

 
5.

Healthcare-associated Infections. Centers for Disease Control and Prevention. https://www.cdc.gov/hai/organisms/pseudomonas.html. Published March 9, 2018. Accessed April 16, 2018.

 
6.

Hirsch EB, Tam VH. Impact of multidrug-resistant Pseudomonas aeruginosa infection on patient outcomes. Expert review of pharmacoeconomics & outcomes research. 2010;10(4):441-451. doi:10.1586/erp.10.49.

 

View source version on businesswire.com: https://www.businesswire.com/news/home/20180605005585/en/

CONTACT

Shionogi & Co., Ltd.
Lindsay Bohlander, +81-6-6209-7885
Corporate
Communications Department

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