Phase 2 Clinical Development of a 'Neoglycoside', a Novel, Broad-Spectrum Antibacterial Therapy for Complicated Urinary Tract Infections, including Pyelonephritis, in a Hospital or Critical Care Setting.

Aminoglycosides are a proven class of antibacterials that remain in extensive clinical use despite increasing bacterial resistance across many species of bacteria. To meet the growing worldwide need for antibiotics that are safe and effective against multi-drug resistant (MDR) bacteria (particularly Gram-negative bacteria and MRSA), Achaogen is developing ACHN-490, a novel neoglycoside, or next-generation aminoglycoside, that overcomes resistance mechanisms that are overwhelming the current arsenal of antibacterial drugs, including ESBLs, KPCs, gyrase mutations, and aminoglycoside-modifying enzymes. ACHN-490 has successfully completed Phase 1 clinical development as an intravenous injection. We propose to advance ACHN-490 into a double-blind, randomized, comparator-controlled study to assess the safety, efficacy, and pharmacokinetics of two doses and two durations of ACHN-490 Injection administered IV in a 3- or 5-day course of treatment for patients with complicated urinary tract infections (cUTI) or acute pyelonephritis (AP) in comparison to a standard therapy (levofloxacin). A secondary objective will be to assess the population pharmacokinetics (PK) of two different doses and two different durations of therapy of ACHN-490 Injection in patients with cUTI/AP. The trial may also provide evidence of the efficacy of higher dose, shorter course therapy of ACHN-490 for these infections types.