Achaogen’s plazomicin (ACHN-490) drug has met all the objectives in the multinational Phase 2 study conducted in adults with complicated urinary tract infections (cUTI) and acute pyelonephritis.
Plazomicin is an aminoglycoside that is being developed as an intravenous treatment for serious Gram-negative bacterial infections, including those caused by multi-drug resistant (MDR) Escherichia coli and Klebsiella pneumoniae.
The Biomedical Advanced Research and Development Authority (BARDA) has awarded Achaogen up to $64.5m in funding to support the development of plazomicin as a medical countermeasure against Yersinia pestis and Francisella tularensis pathogens.
In the Phase 2 study, plazomicin was well-tolerated and showed favourable microbiological and clinical outcomes at the test-of-cure visit, five to nine days after the end of therapy, which were the primary and secondary outcome measures.
Achaogen chief executive officer and chief medical officer Kenneth Hillan said the Phase 2 trial supports plazomicin’s potential utility as a new treatment option for patients with certain serious Gram-negative bacterial infections.
"We plan to consult with the FDA regarding the design of future studies with plazomicin, which we intend to initiate in the first half of 2013. Our goal is to conduct innovative studies that would evaluate plazomicin’s effectiveness in treating seriously ill patients for whom currently available therapies are ineffective," Hillan added.
The company has also initiated dosing in the first-in-human clinical trial of ACHN-975, a LpxC inhibitor that is being developed for the treatment of serious infections caused by multi-drug resistant (MDR) Gram-negative bacteria, including pan-drug resistant Pseudomonas aeruginosa.
In the randomised, double-blind placebo-controlled Phase 1 study, ACHN-975 will be assessed for safety, tolerability and pharmacokinetics in healthy volunteers.
Achaogen is a biopharmaceutical company focused on the development of therapies for serious infections caused by MDR Gram-negative bacteria.