New designations in community-acquired bacterial pneumonia, acute bacterial prostatitis, gonococcal urethritis, and pelvic inflammatory disease demonstrate the clinical potential of sulopenem

DUBLIN, Ireland and CHICAGO, March 19, 2019 (GLOBE NEWSWIRE) -- Iterum Therapeutics plc (Nasdaq: ITRM), a clinical-stage pharmaceutical company developing antibiotics against multi-drug resistant pathogens, today announced that the U.S. Food and Drug Administration (FDA) has granted Qualified Infectious Disease Product (QIDP) to the oral and intravenous (IV) formulations of sulopenem in four new indications, community-acquired bacterial pneumonia, acute bacterial prostatitis, gonococcal urethritis, and pelvic inflammatory disease. These new designations augment Iterum’s existing QIDP designations for oral and IV sulopenem for the treatment of uncomplicated urinary tract infection (uUTI), complicated urinary tract infection (cUTI), and complicated intra-abdominal infection (cIAI), which the FDA granted in 2017. The company is currently conducting three pivotal Phase 3 clinical trials in uUTI, cUTI and cIAI, and expects to report top-line results in the second half of 2019.

Fast Track designation for all seven of these indications in both the oral and intravenous formulations has also been granted.

“These additional FDA designations further validate the clinical potential of sulopenem and provide significant additional support for its development. Sulopenem has demonstrated potent in vitro activity against several antibiotic-resistant pathogens for which new treatments are urgently needed. At this time, we remain focused on completing the Phase 3 program of sulopenem in uUTI, cUTI, and cIAI, and look forward to filing new drug applications with the FDA by year-end.”

Michael Dunne, MD, Chief Scientific Officer of Iterum Therapeutics

To achieve QIDP designation, a drug candidate must be intended to treat serious or life-threatening infections, particularly those caused by bacteria and fungi that are resistant to treatment, or that treat qualifying resistant pathogens identified by the FDA. The QIDP designation will make sulopenem eligible to benefit from certain incentives for the development of new antibiotics provided under the Generating Antibiotic Incentives Now (GAIN) Act. Further, if approved, sulopenem would be eligible for an additional five-year extension of Hatch-Waxman exclusivity. Fast-track status provides an opportunity for more frequent meetings with the FDA, more frequent written communication related to the clinical trials, eligibility for Accelerated Approval and Priority Review and the potential for a Rolling Review, which means that the company can submit completed sections of its New Drug Application (NDA) for review by the FDA, rather than waiting until every section of the NDA is completed.