Iterum Therapeutics Announces Completion of Enrollment in Phase 3 Clinical Trial of Oral and IV Sulopenem in Complicated Urinary Tract Infection

18th November 2019

DUBLIN, Ireland and CHICAGO; November 18, 2019 -- Iterum Therapeutics plc (Nasdaq: ITRM), a clinical-stage pharmaceutical company focused on developing next generation oral and IV antibiotics to treat infections caused by multi-drug resistant pathogens in both community and hospital settings, today announced the completion of patient enrollment in its Sulopenem for Resistant Enterobacteriaceae (SURE) 2 clinical trial in complicated urinary tract infections (cUTI).

“The completion of enrollment in our cUTI trial marks the achievement of another critical milestone in our development program. Completing enrollment in this phase 3 trial brings us another step closer to providing physicians and patients with the first and only oral and intravenous (IV) penem antibiotic, if approved. We look forward to sharing topline results from the SURE 2 trial in early 2020.”

Corey Fishman, Chief Executive Officer of Iterum Therapeutics

This multi-center, double-blind clinical trial is measuring efficacy, tolerability, and safety of IV and oral sulopenem for the treatment of cUTI in adults. Patients are randomized to receive either IV sulopenem once daily for a minimum of five days followed by oral sulopenem/probenecid twice daily to complete 7-10 days of treatment, or IV ertapenem once daily for a minimum of five days followed by oral ciprofloxacin twice daily or, for those patients with a baseline pathogen resistant to ciprofloxacin, to amoxicillin/clavulanate twice daily.

About Complicated Urinary Tract Infections

There are approximately 3.6 million patients with cUTIs that require antibiotic therapy every year in the United States. cUTIs, including acute pyelonephritis, are defined as urinary tract infections ascending from the bladder accompanied by local and systemic signs and symptoms, including fever, chills, malaise, flank pain, back pain, and/or costo-vertebral angle pain or tenderness, that occur in the presence of a functional or anatomical abnormality of the urinary tract or in the presence of catheterization, with treatment typically initiated by IV therapy in a hospital setting. The lack of effective oral step-down options for many patients with cUTIs has meant the potential for lengthy hospital stays or insertion of a peripherally inserted central catheter (PICC) to facilitate administration of IV antibiotics outside of the hospital.

About Sulopenem

Sulopenem, a novel penem anti-infective compound with oral and IV formulations, has demonstrated potent in vitro activity against a wide variety of gram-negative, gram-positive and anaerobic bacteria resistant to other antibiotics. If approved, sulopenem will help address the significant clinical and economic need for new oral antibiotics that enable the avoidance of hospitalization or facilitate early hospital discharge by providing continuity-of-care step-down therapy. The safety profile of IV sulopenem has been documented in a Phase 2 program. Oral and IV sulopenem are being evaluated in pivotal Phase 3 clinical trials of uncomplicated urinary tract infections, complicated urinary tract infections and complicated intra-abdominal infections.

The U.S. Food and Drug Administration (FDA) has granted Special Protocol Agreements (SPA) and Qualified Infectious Disease Product (QIDP) designations for oral and IV sulopenem in accordance with the Generating Antibiotics Incentives Now (GAIN) Act, which will provide five years of additional regulatory exclusivity and expedited Fast Track FDA review.