Update on Iterum Therapeutics Phase 3 trials

18th September 2018

LONDON, 18 September 2018:

Arix Bioscience plc (“Arix”) (LSE: ARIX), a global healthcare and life science company supporting medical innovation, is pleased to note that its Group Business, Iterum Therapeutics plc (“Iterum”) (Nasdaq: ITRM) has initiated the remaining two of three planned Phase 3 pivotal trials (SURE 2 and SURE 3) of IV and Oral Sulopenem in Complicated Urinary Tract and Complicated Intra-abdominal Infections.

Iterum Initiates SURE 2 and SURE 3 Phase 3 Clinical Trials of IV and Oral Sulopenem in Complicated Urinary Tract and Complicated Intra-abdominal Infections

Remaining two of three planned Phase 3 pivotal trials now underway for Iterum’s lead antibiotic product candidate sulopenem

Potential to be first and only oral and IV penem antibiotic available globally

Top-line results for SURE 2 and SURE 3 expected in the second half of 2019, with new drug application (NDA) submissions anticipated by the end of 2019

DUBLIN, Ireland and CHICAGO, September 18, 2018 — Iterum Therapeutics plc (Nasdaq: ITRM), a clinical-stage pharmaceutical company developing antibiotics against multi-drug resistant pathogens, today announced its initiation of the second and third of three planned Phase 3 clinical trials for sulopenem, Iterum’s lead compound and novel antibiotic for the treatment of gram-negative, multi-drug resistant infections.

In the second trial, known as Sulopenem for Resistant Enterobacteriaceae (SURE) 2, IV sulopenem followed by oral sulopenem etzadroxil combined with probenecid in a bilayer tablet (oral sulopenem) will be compared to IV ertapenem followed by oral ciprofloxacin in adults with complicated urinary tract infections (cUTI). In the third trial, known as SURE 3, IV sulopenem followed by oral sulopenem is compared to IV ertapenem followed by a combination of oral ciprofloxacin and oral metronidazole in adults with complicated intra-abdominal infections (cIAI).

Iterum press release available here: https://www.iterumtx.com/news/press-releases/detail/12/iterum-initiatessure-2-and-sure-3-phase-3-clinical-trials

ENDS