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Shionogi to Present Cefiderocol and COT-143 Data at American Society for Microbiology Microbe 2019 Meeting

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OSAKA, Japan & FLORHAM PARK, N.J.–(BUSINESS WIRE)–Shionogi & Co., Ltd. (hereafter “Shionogi”) today announced there will
be one oral presentation and 17 poster presentations featuring two of
the company’s investigational compounds at the American Society for
Microbiology (ASM) Microbe meeting, being held June 20–24, 2019 in San
Francisco. Sixteen poster presentations are on cefiderocol, a late-stage
investigational, novel siderophore cephalosporin, and one is on COT-143,
a humanized monoclonal antibody.

“Cefiderocol has a unique mechanism of cell entry and is able to
overcome the three major mechanisms of carbapenem-resistance of
Gram-negative pathogens. The totality of cefiderocol data to be
presented at ASM Microbe adds to the growing body of evidence of its
potential activity against some of the world’s deadliest pathogens and
we look forward to sharing these findings with the scientific
community,” said Dr. Tsutae Den Nagata, Chief Medical Officer, Shionogi.

In addition, Shionogi will also present a poster on COT-143, an
investigational humanized monoclonal antibody demonstrating
anti-virulence activity targeting the PcrV protein of Pseudomonas
aeruginosa.

Presentations will include data on these Shionogi agents from
company-sponsored or investigator-initiated investigational studies.

The details for the presentations are as follows:

Oral presentation about cefiderocol and COT-143
Date
and time: June 21, 2:30 p.m.-2:41 p.m.
Session title
and location: Session S107: Pharma Pipeline Update: Part 1
Shionogi
Pipeline; AAR Track Hub (Booth 5053) – Learn – exhibit and poster hall
Presenter:
Yoshinori Yamano

The following poster presentations will take
place on the following date and time, and session title and location:

Cefiderocol
Date and time: June
22, 11 a.m.-12 p.m. and 4 p.m.-5 p.m.
Session title and
location: Session P494 – HMB12 – Inflammation During infection; exhibit
and poster hall

Date and time: June 22, 11 a.m.-12 p.m. and 4 p.m.-5 p.m.
Session
title and location: P514 – AAR09 – Pharmacological Studies of
Investigational Agents Phase 2/3: Late-Stage Beta-Lactam Antibiotics; exhibit
and poster hall

Date and time: June 22, 11 a.m.-12 p.m. and 4 p.m.-5 p.m.
Session
title and location: P507 – Antimicrobial Agents: Mechanisms of
Action and Mechanisms of Resistance in Gram-negative ESKAPE Pathogens

COT-143
Date and time: June
23, 11 a.m.-1 p.m.
Session title and location: P586 – AAR06
– Novel Approaches: Therapies, Diagnostics and Drug Discovery: Biologics;
exhibit and poster hall

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 including
multidrug-resistant strains. It has a unique ability to overcome all
three major mechanisms of carbapenem resistance. 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 bacteria.1 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-beta-lactamases.2
These mechanisms allow cefiderocol to achieve higher concentrations in
the periplasmic space where it can bind to receptors and inhibit cell
wall synthesis in the bacterial cells.3 Data from
multinational surveillance studies for cefiderocol demonstrated potent in
vitro activity against a wide spectrum of Gram-negative pathogens
including carbapenem-resistant Acinetobacter baumannii, Pseudomonas
aeruginosa, Enterobacteriaceae, and Stenotrophomonas
maltophilia.4 Cefiderocol has poor in vitro activity
against Gram-positive or anaerobic bacteria. The clinical significance
of in vitro data is unknown.

Two ongoing Phase III studies–in patients with HAP/VAP/HCAP†
(APEKS-NP‡) and with carbapenem-resistant pathogens at various infection
sites (CREDIBLE-CR) have recently completed enrollment. Information is
available at www.clinicaltrials.gov under
the identifiers NCT03032380 and NCT02714595, respectively. The company
submitted a New Drug Application to the U.S. Food and Drug
Administration in December 2018 and a marketing authorization
application to the European Medicines Agency in March 2019.5

About Gram-negative Infections

The increasing resistance of many infections caused by Gram-negative
bacteria to existing therapies, including carbapenem-resistant
Enterobacteriaceae and non-fermenting species such as P. aeruginosa,
A. baumannii, and S. maltophilia, means there is a
critical need for new, effective therapies.4, 6-9 There are
an increasing number of Gram-negative pathogens resistant to multiple
antibiotics, making them difficult to treat and resulting in high
mortality rates.10 In the U.S., at least two million people
are infected with antibiotic-resistant bacteria, and at least 23,000
people die as a result each year.11 The World Health
Organization and the Centers for Disease Control and Prevention have
identified carbapenem-resistant strains of Enterobacteriaceae, P.
aeruginosa, and A.baumannii as the top priority in the
research and development of new antibiotics.6,11

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 U.S. each year and the rates of antibiotic
resistance are increasing worldwide.12-13 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.” 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 information on Shionogi & Co., Ltd., visit www.shionogi.co.jp/en.
Shionogi Inc. is the U.S. subsidiary of Shionogi & Co., Ltd. based in
N.J. For more information on Shionogi Inc., please visit https://www.shionogi.com/.

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.

†Hospital-Acquired Pneumonia/Ventilator-Acquired
Pneumonia/Healthcare-Associated Pneumonia.
‡Nosocomial Pneumonia.

References

1. Ito A, Nishikawa T, Matsumoto 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. 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.

3. 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

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. Antimicrob
Agents Chemother. 2017;61(9):e00093−17. doi.org/10.1128/AAC.00093-17.

5. Shionogi & Co, Ltd. Shionogi announces submission of cefiderocol
marketing authorisation application. April 1, 2019. Retrieved from http://www.shionogi.co.jp/en/company/news/2019/pmrltj000000418y-att/e_190401_2.pdf.

6. World Health Organization. Global priority list of
antibiotic-resistant bacteria to guide research, discovery, and
development of new antibiotics. February 27, 2017. Retrieved from https://www.who.int/medicines/publications/global-priority-list-antibiotic-resistant-bacteria/en/.

7. Diene SM, Rolain JM. Carbapenemase genes and genetic platforms in
gram-negative bacilli: Enterobacteriaceae, Pseudomonas and Acinetobacter
species. Clin Microbiol Infect 2014; 20:831−38.

8. Livermore DM. Current epidemiology and growing resistance of
gram-negative pathogens. Korean J Intern Med 2012; 27:128−42.

9. Brooke JS. Stenotrophomonas maltophilia: an emerging global
opportunistic pathogen. Clin Microbiol Rev 2012; 25:2−41.

10. Tangden T, Giske CG. Global dissemination of extensively
drug-resistant carbapenemase-producing Enterobacteriaceae: clinical
perspectives on detection, treatment and infection control. J Intern
Med 2015; 277:501−12.T.

11. Centers for Disease Control and Prevention (CDC). Antibiotic
Resistance Threats in the United States 2013. Retrieved from https://www.cdc.gov/drugresistance/pdf/ar-threats-2013-508.pdf.

12. Centers for Disease Control and Prevention (CDC) Pseudomonas
aeruginosa in Healthcare Settings. Retrieved from https://www.cdc.gov/hai/organisms/pseudomonas.html.

13. Hirsch EB, Tam VH. Impact of multidrug-resistant Pseudomonas
aeruginosa infection on patient outcomes. Expert Rev Pharmacoecon
Outcomes Res 2010; 10(4):441−451. doi:10.1586/erp.10.49.

Contacts

Shionogi & Co., Ltd.
Corporate Communications
Telephone:
+81-6-6209-7885
Fax: +81-6-6229-9596

Shionogi Inc. U.S. Media Contact
Barbara Kalavik
Advocacy &
Communications
+1 973-307-3373
Barbara.Kalavik@shionogi.com

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