Iterum’s Sulopenem receives FDA approval for treatment of uncomplicated urinary tract infections

1. Sulopenem was superior to amoxicillin/clavulanate and ciprofloxacin in treating antimicrobial resistant uncomplicated urinary tract infections.
2. The antibiotic was safe and well tolerated.

The Latest

Sulopenem has received FDA approval for the treatment of uncomplicated urinary tract infections (uUTI). The approval comes after two successful phase 3 trials. In the SURE 1 trial, a 5-day course of sulopenem was compared to a 3-day course of ciprofloxacin. The results of the trial found that Sulopenem was superior to Ciprofloxacin (62.6% vs 36.0%) in patients with ciprofloxacin-resistant uUTIs. In the REASSURE trial, sulopenem also had a superior response (61.7% vs 55%) to amoxicillin/clavulanate. The drug was safe and well tolerated by patients.

Physician’s Perspective

Urinary tract infections are one of the most common infections around the world with up to 60% of women expected to have an uUTI in their lifetime. Clinical presentations of uUTIs are pain or burning while urinating, frequent urination, and feeling the need to urinate despite having an empty bladder. Complicated UTIs present with the same symptoms as uUTIs but with additional patient factors such as being male, pregnant, immunocompromised, or having recurrent infections despite adequate treatment. The approval of sulopenem now provides physicians another option should standard antibiotics fail.

Molecular Target of Therapy

UTIs can be caused by a variety of bacteria including E. Coli and Klebisella. Over the past decade, there has been an increase in bacterial resistance to antibiotics that are typically used to treat urinary tract infections. Sulopenem is a broad spectrum β-lactam that is formulated with probenecid for urinary tract infection. Sulopenem inhibits bacterial cell wall synthesis by binding to penicillin-binding proteins while the probenecid will reduce the rate of elimination from the body and increase systemic exposure to sulopenem.

Company History:

Founded in 2015, Iterum therapeutics is an Irish based pharmaceutical company focused on developing anti-infectives to solve the multi-drug-resistant crisis. Sulopenem is the company’s first and only product to date that Iterum hopes to use to treat urinary tract infections and complicated intra-abdominal infections.

Additional Reading: https://pmc.ncbi.nlm.nih.gov/articles/PMC9825825/