BioCentury
ARTICLE | Clinical News

Achaogen antibiotic headed toward submissions

December 13, 2016 1:15 AM UTC

Achaogen Inc. (NASDAQ:AKAO) rocketed $7.78 (148%) to $13.03 on Monday after reporting that its lead candidate plazomicin (ACHN-490) met FDA’s and EMA’s primary endpoints in the Phase III EPIC trial in patients with complicated urinary tract infections (cUTIs) and acute pyelonephritis. The company plans to submit regulatory applications to FDA in 2H17 and to EMA in 2018.

On FDA's composite primary endpoint of clinical cure with microbiological eradication, Achaogen said plazomicin showed non-inferiority to meropenem at day 5 (88% vs. 91.4%), and superiority at a subsequent test of cure (TOC) visit (81.7% vs. 70.1%), respectively. The endpoints were evaluated in the trial’s microbiological modified intent-to-treat (mMITT) population...