Iterum Therapeutics Announces Topline Results from Phase 3 Clinical Trial of Oral and IV Sulopenem for the Treatment of Complicated Intra-abdominal Infections
Iterum Therapeutics plc - Ordinary Share (ITRM)
Last iterum therapeutics plc - ordinary share earnings: 11/12 04:30 pm
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Source: GlobeNewswire
DUBLIN, Ireland and CHICAGO, Dec. 10, 2019 (GLOBE NEWSWIRE) -- Iterum Therapeutics plc (Nasdaq: ITRM), a clinical-stage pharmaceutical company focused on developing an oral and IV penem antibiotic to treat infections caused by multi-drug resistant pathogens in both community and hospital settings, today announced topline results from its Sulopenem for Resistant Enterobacteriaceae (SURE) 3 clinical trial in complicated intra-abdominal infections (cIAI). The primary U.S. Food and Drug Administration (FDA) endpoint was clinical response on Day 28 in the micro-MITT population. In this population, the difference in outcomes was 4.7% with a 95% confidence interval on that difference of -10.3% to 1.0%. Non-inferiority required that the lower limit of the difference in the outcome rates be -10% for FDA. SulopenemErtapenemDifference (95% Confidence Interval)Test of Cure microMITT85.5% 90.2% -4.7% (-10.3, 1.0)MITT87.2% 90.0% -2.9% (- 7.7, 2.0)Clinically Evaluable93.5% 95.7%
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