Core Insights - Iterum Therapeutics has reported the publication of results from its Phase 3 REASSURE trial, demonstrating the efficacy of oral sulopenem compared to Augmentin for treating uncomplicated urinary tract infections (uUTIs) in women [1][2] - The trial showed that oral sulopenem was statistically superior to Augmentin, with an overall success rate of 61.7% compared to 55.0% for Augmentin [4] - The FDA has approved ORLYNVAH™, Iterum's new drug for treating uUTIs caused by specific resistant pathogens, based on robust data from the REASSURE trial and another pivotal study [5][6] Company Overview - Iterum Therapeutics focuses on developing next-generation antibiotics to combat multi-drug resistant pathogens in both community and hospital settings [1][9] - The company has received Qualified Infectious Disease Product (QIDP) and Fast Track designations for its oral and IV formulations of sulopenem in seven indications [9] Clinical Trial Details - The REASSURE trial was a non-inferiority study designed to compare oral sulopenem with Augmentin in a population of adult women with uncomplicated uUTIs [2][4] - The trial enrolled 2,222 patients and was conducted under a Special Protocol Assessment (SPA) agreement with the FDA [2] Market Context - UTIs are among the most common bacterial infections, with approximately 15 million emergency room visits and over 40 million prescriptions for uUTIs annually in the U.S. [7] - The increasing rates of multi-drug resistance have made the treatment of uUTIs more challenging, with about 30% of uUTIs caused by quinolone non-susceptible pathogens [7]