Achaogen announce Phase 3 EPIC trial results published

Achaogen announced that the New England Journal of Medicine has published the results from the Phase 3 EPIC study of Zemdri The publication describes the efficacy and safety of Zemdri in adult patients with complicated urinary tract infections, or cUTI, including acute pyelonephritis. The Phase 3 EPIC clinical trial was the first multicenter, multinational, randomized, double-blind and controlled study of once-daily aminoglycoside therapy for the treatment of cUTI, including acute pyelonephritis. Zemdri was noninferior to meropenem for the co-primary efficacy endpoints of composite cure in the microbiological modified intent-to-treat population. Numerically higher composite cure rate for Zemdri was maintained at the late follow-up visit. Clinical relapse of cUTI symptoms was 1.6% for Zemdri vs. 7.1% for meropenem at late follow-up. Microbiological recurrence of the baseline uropathogens was 3.7% for Zemdri vs. 8.1% for meropenem at late follow-up. Numerically higher composite cure rate at TOC in patients with concomitant bacteremia at baseline was seen in the Zemdri group. The incidence of adverse events was similar between treatment groups.
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