Iterum Therapeutics to Present Data from Phase 3 Trials in Uncomplicated and Complicated Urinary Tract Infections at IDWeek 2020

Rhea-AI Summary

Iterum Therapeutics announced two upcoming data presentations at the IDWeek™ 2020, set for October 21-25, 2020. This includes findings from the SURE-1 trial demonstrating oral sulopenem's effectiveness against uncomplicated urinary tract infections (uUTI) compared to oral ciprofloxacin, deemed statistically superior. Additionally, results from the SURE-2 trial on complicated urinary tract infections (cUTI) will be shared. The company is progressing with sulopenem as a novel anti-infective aimed at combating antibiotic resistance.

Positive

• Presentation of statistically superior results of oral sulopenem over ciprofloxacin in uUTI treatment from SURE-1 trial.
• SURE-2 results presentation on cUTI treatment expected to bolster the market position of sulopenem.
• Sulopenem is in Phase 3 development with received designations that can expedite the approval process.

Negative

• None.

Data presentations to cover both SURE-1 and SURE-2 urinary tract infection studies

DUBLIN, Ireland and CHICAGO, Oct. 19, 2020 (GLOBE NEWSWIRE) -- Iterum Therapeutics plc (Nasdaq: ITRM) (the “Company”), a clinical-stage pharmaceutical company focused on developing next generation oral and IV antibiotics to treat infections caused by multi-drug resistant pathogens in both community and hospital settings, today announced that it will have two data presentations at the Infectious Disease Society of America (IDSA) IDWeek™ 2020 taking place virtually from October 21 - 25, 2020. The two data presentations will include a poster presentation of the results of SURE-2 in complicated urinary tract infections (cUTI) as well as a late breaker oral abstract presentation of the results from SURE-1 in uncomplicated urinary tract infections (uUTI). In June 2020, the Company announced top-line data from the SURE-1 trial demonstrating that oral sulopenem was statistically superior to oral ciprofloxacin in the treatment of patients with uUTI caused by a quinolone non-susceptible pathogen.

Presentation Title: Efficacy and Safety of Oral Sulopenem Etzadroxil/Probenecid Versus Oral Ciprofloxacin in the Treatment of Uncomplicated Urinary Tract Infections (uUTI) in Adult Women: Results from the SURE-1 Trial
Session Name: STIs & UTIs
Presenter: Michael Dunne
Date: October 21, 2020

Title: Efficacy and Safety of Intravenous Sulopenem Followed by Oral Sulopenem etzadroxil/ Probenecid Versus Intravenous Ertapenem Followed by Oral Ciprofloxacin or Amoxicillin-clavulanate in the Treatment of Complicated Urinary Tract Infections (cUTI): Results from the SURE-2 Trial
Poster Session: : STIs & UTIs
Presenter: Michael Dunne
Date: October 21, 2020

Abstracts are accessible via the IDWeek™ website. Poster presentations may be accessed through the Company’s website on the “Publications: Posters & Presentations” page under the “Our Science” tab following their completion.

About Iterum Therapeutics plc

Iterum Therapeutics plc is a 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, in Phase 3 clinical development with an oral formulation and IV formulation. Sulopenem 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 Qualified Infectious Disease Product (QIDP) and Fast Track designations for its oral and IV formulations of sulopenem in seven indications.

Forward-Looking Statements

This press release contains 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,” “would,” “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 the Company’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. 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 the Company’s control, including the uncertainties inherent in the initiation and conduct of clinical trials,  availability and timing of data from clinical trials, changes in regulatory requirements or decisions of regulatory authorities, the Company’s ability to apply for regulatory approval and the timing of approval of any submission, changes in public policy or legislation, commercialization plans and timelines, if sulopenem is approved, the actions of third-party clinical research organizations, suppliers and manufacturers, the accuracy of the Company’s expectations regarding how far into the future the Company’s cash on hand will fund the Company’s ongoing operations, the sufficiency of the Company’s cash resources and the Company’s ability to continue as a going concern, the impact of COVID-19 and related responsive measures thereto, the Company’s ability to maintain listing on the Nasdaq Stock Market, risks and uncertainties concerning the outcome, impact, effects and results of the Company’s evaluation of corporate, organizational, strategic, financial and financing alternatives, including the terms, timing, structure, value, benefits and costs of any corporate, organizational, strategic, financial or financing alternative and the Company’s ability to complete one at all, the price of the Company’s securities and other factors discussed under the caption “Risk Factors” in its most recently filed Quarterly Report on Form 10-Q, and other documents filed with the SEC from time to time. Forward-looking statements represent the Company’s beliefs and assumptions only as of the date of this press release. Except as required by law, the Company 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
312-778-6073
IR@iterumtx.com

FAQ

What are the results of the SURE-1 trial presented by Iterum Therapeutics?

The SURE-1 trial results show that oral sulopenem is statistically superior to oral ciprofloxacin for treating uncomplicated urinary tract infections (uUTI).

When will Iterum Therapeutics present data from the SURE-2 trial?

Data from the SURE-2 trial will be presented on October 21, 2020, at IDWeek™ 2020.

What is sulopenem's significance in antibiotic treatment?

Sulopenem represents a novel anti-infective option aimed at treating multi-drug resistant infections, critical in today's healthcare landscape.

How does the presentation at IDWeek™ 2020 impact Iterum Therapeutics' market position?

Presenting data on sulopenem's effectiveness could enhance Iterum Therapeutics' market position by demonstrating its viability against resistant pathogens.