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Iterum Therapeutics Presents Data on Risks for Treatment Failure Associated with Uncomplicated Urinary Tract Infection and Activity of its Novel Antibiotic Sulopenem at ECCMID 2019

The highest risk of treatment failure is seen in patients previously infected with a resistant pathogen.

Sulopenem has in vitro activity against isolates of Neisseria gonorrhoeae non-susceptible to quinolones, azithromycin or β-lactams.

DUBLIN, Ireland and CHICAGO, April 11, 2019 (GLOBE NEWSWIRE) -- Iterum Therapeutics plc, (ITRM) a clinical-stage pharmaceutical company developing anti-infectives against multi-drug resistant pathogens, will present three posters at the European Congress of Clinical Microbiology & Infectious Diseases (ECCMID) in Amsterdam, Netherlands on April 15, 2019.

“The rapidly rising rates of antibacterial resistance in pathogens associated with uncomplicated urinary tract infections are making successful treatment more challenging for physicians while patients are experiencing more significant clinical consequences,” said Michael Dunne, M.D., Chief Scientific Officer of Iterum Therapeutics. “The elderly and those with diabetes mellitus are especially at risk for treatment failure and need better diagnostic and therapeutic options for this disease.”

“As with urinary tract infections, the prevalence of resistant gonorrhoeae infections is also on the rise. We believe sulopenem, which is being developed in oral and intravenous formulations, has considerable potential as an important new treatment option to help patients and physicians better address infections caused by resistant pathogens.”

Poster Presentation p1656. Session: Urinary tract infections. 12:30 - 1:30PM CET

A patient-specific clinical predictive model to anticipate the risk of treatment failure in uncomplicated urinary tract infections

The authors reviewed the records of 4,792 patients given oral antibiotics for uncomplicated urinary tract infections (uUTIs) and assessed the difference in 28-day outcomes for patients with a uUTI whose pathogens were susceptible to empiric therapy versus those who were non-susceptible to therapy, highlighting the risk factors associated with failure.  They concluded:

  • The most significant risk for treatment failure is treatment of the index infection with an antibiotic to which the organism in a prior infection was resistant.
  • Age, gender and diabetes mellitus also increased the likelihood of treatment failure.
  • Treatment failure and hospitalization rates double with mismatched empiric antibiotic therapy.
  • The more antibiotic class resistance, the higher likelihood of treatment failure.

Poster Presentation p1705. Session: Sexually transmitted infections complicated by antimicrobial resistance. 12:30 -1:30PM CET.

In vitro activity of Sulopenem against resistant Neisseria gonorrhoeae volunteers  

  • Sulopenem demonstrated in vitro activity against isolates of N. gonorrhoeae non-susceptible to ceftriaxone and cefixime, as well as those resistant to azithromycin or ciprofloxacin.

Poster Presentation p1992. Session: Evaluation of diverse antimicrobials in vitro and experimental models. 1:30PM - 2:30PM CET.

Post-antibiotic and sub-inhibitory minimum inhibitory concentration effects of Sulopenem

  • Sulopenem exhibited a post antibiotic-subMIC effect, which potentially reflects additional antibacterial activity due to exposure of the bacteria to higher concentrations of drug.
  • Sulopenem may be active for a longer period of the dosing interval than is defined simply by the amount of time the bacteria is exposed to drug levels at the mean inhibitory concentration.

The three posters will be available for review on Monday, April 15, 2019.

About Iterum Therapeutics plc

Iterum Therapeutics plc (Iterum Therapeutics) is an Irish clinical-stage pharmaceutical company dedicated to developing differentiated anti-infectives aimed at combatting the global crisis of multi-drug resistant pathogens to significantly improve the lives of people affected by serious and life-threatening diseases around the world. Iterum Therapeutics is advancing its first compound, sulopenem, a novel penem anti-infective compound with oral and IV formulations that has demonstrated potent in vitro activity against a wide variety of gram-negative, gram-positive and anaerobic bacteria resistant to other antibiotics. Iterum Therapeutics has received QIDP designations for its oral and IV formulations for the treatment of uUTI, complicated urinary tract infection and complicated intra-abdominal infection as well as acute bacterial prostatitis, community-acquired bacterial pneumonia, gonococcal urethritis and pelvic inflammatory disease. For more information, please visit http://www.iterumtx.com.

Forward-looking Statements

This press release may contain forward-looking statements. These forward-looking statements include, without limitation, statements regarding the development, therapeutic and market potential of sulopenem. In some cases, forward-looking statements can be identified by words such as “may,” “believes,” “intends,” “seeks,” “anticipates,” “plans,” “estimates,” “expects,” “should,” “assumes,” “continues,” “could,” “will,” “future,” “potential” or the negative of these or similar terms and phrases. Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause Iterum Therapeutics’ actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. Forward-looking statements include all matters that are not historical facts. Actual future results may be materially different from what is expected due to factors largely outside Iterum Therapeutics’ control, including the uncertainties inherent in the initiation and conduct of clinical trials, clinical trial patient enrollment, availability and timing of data from clinical trials, changes in regulatory requirements or decisions of regulatory authorities, the actions of third-party clinical research organizations, suppliers and manufacturers, commercialization plans and timelines, if approved, and other factors discussed under the caption “Risk Factors” in its most recently filed Annual Report on Form 10-K or Quarterly Report on Form 10-Q (as the case may be), and other documents filed with the SEC from time to time. Forward-looking statements represent Iterum Therapeutics’ beliefs and assumptions only as of the date of this press release. Except as required by law, Iterum Therapeutics assumes no obligation to update these forward-looking statements publicly, or to update the reasons actual results could differ materially from those anticipated in the forward-looking statements, even if new information becomes available in the future.  

Investor Contact:
Judy Matthews
Chief Financial Officer
+1 312-778-6073
IR@iterumtx.com

Media Contact:
Claire LaCagnina
6 Degrees
315-765-1462
clacagnina@6degreespr.com