Achaogen Announces All Objectives Met in Phase 2 Plazomicin Complicated Urinary Tract Infections Study and Start of First-in-Human Study with ACHN-975
Key milestones achieved with two internally-discovered clinical candidates being developed to treat multi-drug resistant Gram-negative infections
SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--May 15, 2012 - Achaogen, Inc. announced today that all objectives were met in the company's multi-national Phase 2 study of plazomicin compared to levofloxacin for the treatment of complicated urinary tract infections (cUTI) and acute pyelonephritis in adults. Achaogen is developing plazomicin, a next-generation aminoglycoside that overcomes common bacterial resistance mechanisms, as an intravenous treatment for serious Gram-negative bacterial infections, including those caused by multi-drug resistant (MDR) Escherichia coli and Klebsiella pneumoniae. In addition, the Biomedical Advanced Research and Development Authority (BARDA) previously awarded Achaogen up to $64.5 million in funding to support the development of plazomicin as a potential medical countermeasure against the biothreat pathogens, Yersinia pestis and Francisella tularensis.
The Phase 2 study met its objectives of assessing safety and efficacy of plazomicin in comparison to levofloxacin. Plazomicin was well-tolerated and demonstrated favorable microbiological and clinical outcomes at the Test-of-Cure Visit, 5 to 9 days after the end of therapy, which were the primary and secondary outcome measures in this study, respectively. Achaogen intends to present data from the study at an upcoming medical conference.
"We are pleased that the data from this Phase 2 trial support plazomicin's potential utility as an important new treatment option for patients with certain serious Gram-negative bacterial infections," said Kenneth J. Hillan, M.B. Ch.B., Chief Executive Officer and Chief Medical Officer of Achaogen. "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."
Achaogen, Inc. also announced today that it has begun dosing in the first-in-human clinical trial of ACHN-975, a first-in-class LpxC inhibitor that is being developed for the treatment of serious infections caused by MDR Gram-negative bacteria, including pan-drug resistant Pseudomonas aeruginosa. The investigational new drug application for ACHN-975 was filed with the U.S. Food and Drug Administration (FDA) in the first quarter of 2012. The Phase 1 randomized, double-blind, placebo-controlled study will evaluate the safety, tolerability, and pharmacokinetics of single ascending doses of ACHN-975 in healthy volunteers. The study is funded under a contract award to Achaogen by the Defense Medical Research and Development Program. A second Phase 1 study of multiple ascending doses of ACHN-975 administered for up to 14 days is planned to follow the single dose study.
"Our mission at Achaogen is to discover and develop antibiotics to treat patients with life-threatening bacterial infections," Hillan added. "The advancement of ACHN-975 into human clinical studies represents an important scientific milestone in our field and an opportunity to work with clinicians and regulators to establish an appropriate development path for an antibiotic with exceptional potency against Pseudomonas aeruginosa, a pathogen that kills tens of thousands of people every year."
Achaogen is a biopharmaceutical company dedicated to discovering and developing treatments for serious infections caused by multi-drug resistant (MDR) Gram-negative bacteria. The company's pipeline of antibacterial drug candidates includes plazomicin (ACHN-490), a next-generation aminoglycoside in Phase 2 clinical development, ACHN-975, a first-in-class LpxC-inhibitor in Phase 1 clinical development, and one earlier-stage molecule that also targets MDR Gram-negative bacteria. Achaogen has established and maintained its specialized research and development using a blend of funding from private investments and partnerships with governmental entities, including BARDA, the National Institute of Allergy and Infectious Diseases (NIAID), and the U.S. Department of Defense.
Posted: May 2012