Iterum Therapeutics Presents Phase 3 Sulopenem Data for UTIs at IDWeek 2020
Key Insights
Iterum Therapeutics (search) presented Phase 3 data for sulopenem in complicated and uncomplicated urinary tract infections (search) (UTIs) at IDWeek 2020.
The SURE-1 trial demonstrated oral sulopenem's superiority to oral ciprofloxacin in treating uncomplicated UTIs caused by quinolone non-susceptible pathogens.
SURE-2 trial results for complicated UTIs involved IV sulopenem followed by oral sulopenem, compared to IV ertapenem followed by oral ciprofloxacin or amoxicillin-clavulanate (search).
Iterum Therapeutics (search) plc (Nasdaq: ITRM) announced the presentation of data from its Phase 3 trials, SURE-1 and SURE-2, evaluating sulopenem for the treatment of uncomplicated and complicated urinary tract infections (search) (UTIs) respectively, at the virtual IDWeek 2020 conference. These presentations highlight the potential of sulopenem as a next-generation antibiotic to combat multi-drug resistant pathogens in both community and hospital settings.
SURE-1 Trial: Oral Sulopenem Demonstrates Superiority in Uncomplicated UTIs
The SURE-1 trial (Efficacy and Safety of Oral Sulopenem Etzadroxil/Probenecid Versus Oral Ciprofloxacin in the Treatment of Uncomplicated Urinary Tract Infections (search) (uUTI) in Adult Women) evaluated the efficacy and safety of oral sulopenem compared to oral ciprofloxacin in adult women with uncomplicated UTIs (uUTI). Top-line data, previously announced in June 2020, indicated that oral sulopenem was statistically superior to oral ciprofloxacin in treating uUTIs caused by quinolone non-susceptible pathogens. This is particularly significant given the increasing resistance to quinolones, a commonly prescribed class of antibiotics for UTIs.
SURE-2 Trial: Sulopenem for Complicated UTIs
The SURE-2 trial (Efficacy and Safety of Intravenous Sulopenem Followed by Oral Sulopenem etzadroxil/ Probenecid Versus Intravenous Ertapenem Followed by Oral Ciprofloxacin or Amoxicillin-clavulanate (search) in the Treatment of Complicated Urinary Tract Infections (search) (cUTI)) investigated the use of intravenous sulopenem followed by oral sulopenem, compared to intravenous ertapenem followed by oral ciprofloxacin or amoxicillin-clavulanate, in the treatment of complicated UTIs (cUTI). The trial aimed to assess the efficacy and safety of sulopenem in a more complex patient population often requiring hospitalization.
Sulopenem: A Novel Penem Anti-Infective
Sulopenem is a novel penem anti-infective compound being developed by Iterum Therapeutics (search) in both oral and IV formulations. It 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 both formulations of sulopenem in seven indications, highlighting its potential to address unmet needs in the treatment of multi-drug resistant infections.
These Phase 3 data presentations at IDWeek 2020 underscore Iterum Therapeutics (search)' commitment to developing differentiated anti-infectives to combat the global crisis of multi-drug resistance and improve outcomes for patients with serious and life-threatening infections.