Iterum Therapeutics plc has announced that the United States Patent and Trademark Office (USPTO) has issued a Notice of Allowance for U.S. patent application number 16/372,075, entitled “Combinations of Beta-Lactam Compounds and Probenecid and Uses Thereof.” This patent covers the use of sulopenem etzadroxil and probenecid in combination, potentially treating multiple diseases, including uncomplicated urinary tract infections (uUTIs). The allowance strengthens Iterum's intellectual property position as it continues Phase 3 clinical trials for oral sulopenem.
The forthcoming patent, expected to be issued after administrative processes, will expire on April 1, 2039, absent any extensions. This adds to the existing patent protection for the oral sulopenem bilayer tablet, also expiring in 2039. The company also has pending patent applications outside the U.S., including in Europe and China.
Clinical Development and Potential Impact
Iterum Therapeutics is currently conducting a pivotal Phase 3 clinical trial evaluating oral sulopenem for the treatment of uUTIs. Corey Fishman, Chief Executive Officer of Iterum, stated, “Enrollment in our pivotal Phase 3 clinical trial for oral sulopenem for the treatment of uncomplicated urinary tract infections is ongoing, and we expect to provide an update following an interim analysis at 50% patient enrollment.”
Sulopenem is a penem anti-infective compound with potent in vitro activity against a wide variety of gram-negative, gram-positive, and anaerobic bacteria resistant to other antibiotics. Both oral and IV formulations of sulopenem have received Qualified Infectious Disease Product (QIDP) and Fast Track designations for multiple indications.
Addressing Unmet Needs in Antibiotic Therapy
If approved, oral sulopenem would be the first oral penem antibiotic available in the United States. This is particularly significant given the increasing prevalence of multi-drug resistant pathogens in both community and hospital settings. The availability of an oral penem could provide a valuable treatment option for infections that are becoming increasingly difficult to treat with existing antibiotics.
