- Trial Initiation Marks Company’s First Neoglycoside to Enter Clinic -
SAN FRANCISCO, CA, February 3, 2009 – Achaogen, an emerging biopharmaceutical company addressing the issue of multi-drug resistant bacterial infections through the discovery and development of innovative broad-spectrum antibiotics, today announced that it has initiated its first Phase 1 clinical trial. This trial is designed to evaluate the safety, tolerability and pharmacokinetics of single and multiple doses of ACHN-490, the Company’s lead bactericidal agent, in at least 32 healthy volunteers. The trial – a randomized, double-blind, placebo-controlled, parallel group, dose-escalation study of intravenously administered ACHN-490 – is supported by the £4.1 million Seeding Drug Discovery award received from the Wellcome Trust, as announced by the Company last month.
Kevin Judice, Chief Executive Officer and Chief Scientific Officer of Achaogen, said, “We are very pleased that a promising neoglycoside compound discovered at Achaogen is being studied in our first clinical trial. We expect this initial clinical study of ACHN-490 to inform the dosing and trial design of our Phase 2 study in complicated urinary tract infection (cUTI), as well as additional future studies addressing complicated intra-abdominal infections, bloodstream infections and other serious, unmet medical needs in the hospital setting. We expect to complete this trial in 2009, and initiate a Phase 2 study in early 2010. The advancement of ACHN-490 and our entire portfolio – including our expanded spectrum neoglycosides in development – is indicative of our commitment to provide therapies to treat multi-drug resistant bacterial infections, particularly those caused by Gram-negative bacteria.”
ACHN-490 is the lead compound in Achaogen’s portfolio of proprietary neoglycosides, the Company’s unique, next-generation aminoglycoside antibiotics. It displays broad-spectrum activity against MDR Gram-negative bacteria that cause systemic infections, including highly resistant Enterobacteriaceae (e.g., E. coli and Klebsiella pneumoniae), and methicillin-resistant Staphylococcus aureus (MRSA). In preclinical studies, ACHN-490 has demonstrated an acceptable safety profile and the potential for once-daily dosing. Achaogen will be exploring new dosing paradigms for its neoglycosides to maximize both efficacy and safety.
Aminoglycosides are a proven class of antibacterials in extensive clinical use, generating over $650 million in sales worldwide. There has not been a new member of this important class approved for decades, however, and the utility of existing aminoglycosides, like other classes of antibacterials, is declining rapidly due to the rapid spread of resistant bacterial strains – one of the most critical and worrisome issues facing healthcare today.
Achaogen is an emerging biopharmaceutical company focused on the discovery and development of innovative, broad-spectrum antibiotics to treat multi-drug resistant bacterial infections. Resistance to available antibacterial therapies continues to rise at an alarming rate, and Achaogen is poised to meet the evolving needs of this market by applying its anticipatory science to develop drugs today that will combat tomorrow’s resistant pathogens. This scientific strategy represents a novel approach to addressing the global bacterial resistance crisis. Achaogen is creating new medicines that anticipate the next wave of anti-bacterial infections, including agents for the underserved Gram-negative infectious disease market and methicillin-resistant Staphylococcus aureus (MRSA), including its portfolio of next-generation aminoglycosides, the neoglycosides. South San Francisco-based Achaogen is backed by top-tier venture investors and has received substantial non-dilutive funding from NIH, the US Department of Defense, and other sources. Venture capital investors include 5 AM Ventures, ARCH Venture Partners, Domain Associates, Venrock Associates and Versant Ventures. For more information, please visit the company’s website at www.achaogen.com.
Sondra Newman, Pure Communications