Iterum Therapeutics Announces Topline Results from Phase 3 Clinical Trial of Oral and IV Sulopenem for the Treatment of Complicated Intra-abdominal Infections

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.

	Sulopenem		Ertapenem		Difference (95% Confidence Interval)
Test of Cure
microMITT	85.5%		90.2%		-4.7% (-10.3, 1.0)
MITT	87.2%		90.0%		-2.9% (- 7.7, 2.0)
Clinically Evaluable	93.5%		95.7%		-2.0% (-5.7, 1.7)
Microbiologically Evaluable	92.5%		95.5%		-3.0% (-7.5, 1.4)
End of Treatment
microMITT	83.5%		85.3%		-1.8% (- 8.1, 4.5)
MITT	83.7%		85.4%		-1.7% (-7.1, 3.8)
Clinically Evaluable	89.4%		90.0%		-0.7% (-5.6, 4.3)
Microbiologically Evaluable	88.5%		88.9%		-0.4% (-6.3, 5.4)

In a prespecified multiple imputation analysis designed to address any imbalances in patients with indeterminate outcomes at the test of cure in the microMITT population, the difference in outcomes was 4.7% with a 95% confidence interval on that difference of -9.9% to 0.5%.