Arch Biopartners said that it has begun manufacturing clinical trial supplies for a Phase 1 study of its AB569 sodium nitrite/ethylenediaminetetraacetic acid (EDTA) inhalation solution for the treatment of antibiotic-resistant bacterial lung infections, and the trial will begin as soon as the supplies are available.
The study will evaluate PK and safety data of nebulized AB569 administered to healthy volunteers.
In October 2016, Arch announced that the Cincinnati Veterans Affairs Medical Center (CVAMC) will conduct both Phase 1 and Phase 2 studies of AB569, with CVAMC Chief of Medicine Ralph Panos as lead investigator.
Pano commented, “This is an important trial to show clinicians that AB569 is safe for use in humans. Once we establish that, we look forward to transitioning the AB569 program into a Phase 2 trial at CVAMC where we can test the drug’s efficacy in treating antibiotic resistant infections in the lungs of patients with COPD. Greater than 40% of patients at the CVAMC have COPD and AB569 has the potential to solve a major clinical challenge we currently face.”
According to the company, pre-clinical testing has shown that AB569 is effective against numerous gram-negative and gram-positive bacteria collected from hospital patients and does not harm human cells.
Arch board member Claude Allary said, “At a time where new treatments are urgently needed to kill highly problematic, antibiotic-resistant bacteria, moving AB569 into a Phase I human trial at CVAMC is a major milestone for the program and the development of Arch Biopartners.”
Read the Arch Biopartners press release.