Sulopenem

Iterum Therapeutics Announces Completion of Enrollment in its REASSURE Phase 3 Clinical Trial of Oral Sulopenem in Uncomplicated Urinary Tract Infections

Retrieved on: 
Tuesday, October 24, 2023
FDA, Food, ITRM, IV, Probenecid, Renewable Fuels Agency, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Urinary tract infection, Clinical trial, New Drug Application, Woman, NDA, Therapy, Infection, Pharmaceutical industry, Sulopenem

DUBLIN, Ireland and CHICAGO, Oct. 24, 2023 (GLOBE NEWSWIRE) -- Iterum Therapeutics plc (Nasdaq: ITRM) (Iterum), 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 the completion of patient enrollment in its REASSURE (REnewed ASsessment of Sulopenem in uUTI caused by Resistant Enterobacterales) clinical trial comparing oral sulopenem (sulopenem etzadroxil combined with probenecid in a bilayer tablet) to oral Augmentin® (amoxicillin/clavulanate) in adult women with uncomplicated urinary tract infections (uUTI).

Key Points: 
  • DUBLIN, Ireland and CHICAGO, Oct. 24, 2023 (GLOBE NEWSWIRE) -- Iterum Therapeutics plc (Nasdaq: ITRM) (Iterum), 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 the completion of patient enrollment in its REASSURE (REnewed ASsessment of Sulopenem in uUTI caused by Resistant Enterobacterales) clinical trial comparing oral sulopenem (sulopenem etzadroxil combined with probenecid in a bilayer tablet) to oral Augmentin® (amoxicillin/clavulanate) in adult women with uncomplicated urinary tract infections (uUTI).
  • “We are extremely pleased to have completed enrollment in our REASSURE trial well ahead of schedule.
  • We now expect topline results early in the first quarter of 2024, and subject to our analysis of the data, plan to resubmit our NDA to the FDA in the second quarter of 2024,” said Corey Fishman, Chief Executive Officer.
  • Provided that the resubmitted NDA addresses all of the deficiencies identified in the complete response letter Iterum received from the FDA in July 2021, Iterum expects that the FDA will complete its review and take action six months from the date the FDA receives the resubmitted NDA (or during the second half of 2024).

Iterum Therapeutics Reports Fourth Quarter and Full Year 2022 Financial Results

Retrieved on: 
Thursday, March 16, 2023
Therapy, Clinical trial, Prejudice, Regulation of tobacco by the U.S. Food and Drug Administration, R, Probenecid, SPA, Patent, Urinary tract infection, Senior, District court, ITRM, Investment, Woman, Research, FDA, China International Search and Rescue Team, National Renewable Energy Laboratory, G&A, Consultant, Infection, IV, Food, NDA, United States Patent and Trademark Office, Pharmaceutical industry, Cryptocurrency, Sulopenem

DUBLIN, Ireland and CHICAGO, March 16, 2023 (GLOBE NEWSWIRE) -- Iterum Therapeutics plc (Nasdaq: ITRM), 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 reported financial results for the fourth quarter and year ended December 31, 2022.

Key Points: 
  • Patents Issued: The United States Patent and Trademark Office has issued Iterum two new patents: 1) US Patent No.
  • In addition, during the fourth quarter of 2022, a change in the discount rate impacted the fair value of the Limited Recourse Royalty-Linked Subordinated Notes (the “Royalty-Linked Notes”).
  • Non-GAAP1 net loss for the fourth quarter and full year 2022 of $6.4 million and $22.9 million, respectively, compared to a non-GAAP1 net loss of $3.3 million and $19.4 million for the same periods in 2021.
  • Iterum will host a conference call today, Thursday, March 16, 2023 at 8:30 a.m. Eastern Time.