Topline results from uUTI and cUTI clinical trials to be announced in Q2 2020

Iterum Therapeutics maintaining business operations amid COVID-19 public health crisis

DUBLIN, Ireland and CHICAGO, March 31, 2020 (GLOBE NEWSWIRE) -- 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 that it anticipates reporting topline results from its Sulopenem for Resistant Enterobacteriaceae (SURE) 1 clinical trial in uUTI and SURE 2 clinical trial in cUTI in the early part of the second quarter of 2020.

As previously announced, patient enrollment and treatment for SURE 1 and SURE 2 clinical trials were completed in early 2020.

“Despite the COVID-19 pandemic, we are working closely with our partners as they complete the processing of data and wrap-up the final steps necessary to enable us to report topline results from these clinical trials as close as possible to our original timeline of around the end of the first quarter. We look forward to sharing results in the near-term and remain confident in the potential of sulopenem to become the first and only oral and IV penem antibiotic treatment option to help address the ongoing, global threat caused by multi-drug resistant infections impacting both hospital and community settings.”

Corey Fishman, Chief Executive Officer of Iterum Therapeutics

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 for 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.