Iterum Therapeutics (NASDAQ:ITRM) announces the results from a Phase 3 clinical trial, SURE 3, evaluating penem anti-infective sulopenem in patients complicated intra-abdominal infections (cIAI).
The trial (narrowly) missed the primary endpoint of clinical response at day 28 compared to ertapenem, thereby failing to demonstrate non-inferiority. Specifically, the 95% confidence interval required a lower limit of the difference in outcomes of no more than 10.0%. The results showed an interval of -10.3% to 1.0%.
On the safety front, the rates of treatment-related adverse events for sulopenem and ertapenem were 6.0% and 5.1%, respectively, with the most common being diarrhea, 4.5% and 2.4%, respectively. Serious adverse events were higher with sulopenem (7.5%) than ertapenem (3.6%) but the discontinuation rate was lower, 1.5% vs. 2.4%.
Topline data from another Phase 3 should be available next quarter. If positive, the company intends to proceed with a U.S. marketing application.
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