Iterum Therapeutics Presents Scientific Posters at ECCMID 2023 Highlighting Application of Desirability of Outcomes Ranking (DOOR) to two Registration Trials

Rhea-AI Summary

Dublin, Ireland and Chicago, April 20, 2023 – Iterum Therapeutics (Nasdaq: ITRM) announced the presentation of two posters at the 33rd Annual European Congress of Clinical Microbiology and Infectious Disease (ECCMID) in Copenhagen on April 17, 2023. The presentations focused on a novel analysis method called Desirability of Outcome Ranking (DOOR) applied to Phase 3 trials of their antibiotic sulopenem for uncomplicated (uUTI) and complicated urinary tract infections (cUTI). Key findings demonstrated that oral sulopenem was more effective than ciprofloxacin for uUTI and comparable to ertapenem for cUTI. This approach, though not yet a primary endpoint for regulatory approval, reflects a commitment to evaluating patient outcomes comprehensively. Iterum is advancing sulopenem, an innovative treatment for multi-drug resistant infections, with QIDP and Fast Track designations for multiple indications.

Positive

• Sulopenem showed higher efficacy than ciprofloxacin for uUTI and comparable efficacy to ertapenem for cUTI.
• The company is advancing its first compound, sulopenem, in Phase 3 clinical development.
• Sulopenem has received Qualified Infectious Disease Product (QIDP) and Fast Track designations for seven indications.

Negative

• None.

DUBLIN, Ireland and CHICAGO, April 20, 2023 (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 two posters were presented at the 33^rd Annual European Congress of Clinical Microbiology and Infectious Disease (ECCMID) held in Copenhagen.

The posters presented at ECCMID were:

1. Title: Desirability of outcome ranking (DOOR): application to a phase 3 registrational trial evaluating sulopenem for patients with uncomplicated urinary tract infection (uUTI)
   Presenting Author: Sailaja Puttagunta, MD
   Date: April 17, 2023
   
   
2. Title: Desirability of outcome ranking (DOOR): application to a phase 3 registrational trial evaluating sulopenem for patients with complicated urinary tract infection (cUTI)
   Presenting Author: Sailaja Puttagunta, MD
   Date: April 17, 2023

The desirability of outcome ranking (DOOR), not yet accepted by regulatory authorities as a primary endpoint for urinary tract infection studies, is a novel method of analyzing data from clinical trials taking into account both benefits and harms of drugs being evaluated and providing an assessment of the patient experience. It was utilized recently by the Antibacterial Resistance Leadership Group (ARLG) to develop a method to evaluate data from completed pivotal cUTI trials. “Applying the ARLGs approach retrospectively to our two Phase 3 studies of sulopenem, one each in cUTI and uUTI, respectively, demonstrated that oral sulopenem was comparably more effective than ciprofloxacin in patients with uUTI and provided comparable efficacy to ertapenem in patients with cUTI,” said Dr. Sailaja Puttagunta, Chief Medical Officer of Iterum Therapeutics.

These Posters are available on the Company’s website on the “Publications: Posters & Presentations” page under the “Our Science” tab.

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 is currently advancing its first compound, sulopenem, a novel penem anti-infective compound, in Phase 3 clinical development with an oral formulation. Sulopenem also has an 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 has received Qualified Infectious Disease Product (QIDP) and Fast Track designations for its oral and IV formulations of sulopenem in seven indications. For more information, please visit http://www.iterumtx.com.

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

FAQ

What were the main findings from Iterum Therapeutics' presentations at ECCMID 2023?

The findings indicated that sulopenem was more effective than ciprofloxacin for uncomplicated urinary tract infections and comparable to ertapenem for complicated urinary tract infections.

What is sulopenem and its relevance in the market?

Sulopenem is a novel antibiotic being developed by Iterum Therapeutics to treat multi-drug resistant infections, currently in Phase 3 clinical trials.

When and where were the posters presented by Iterum Therapeutics?

The posters were presented on April 17, 2023, at the 33rd Annual European Congress of Clinical Microbiology and Infectious Disease in Copenhagen.

What designations has Iterum Therapeutics received for sulopenem?

Iterum Therapeutics has received Qualified Infectious Disease Product (QIDP) and Fast Track designations for sulopenem across seven indications.