A Phase 1 clinical trial testing Arch Biopartners’ AB569 for the treatment of antibiotic-resistant bacterial infections is now enrolling healthy volunteers. The therapy candidate could be a new help for patients with cystic fibrosis (CF), chronic obstructive pulmonary disease (COPD), and other respiratory conditions.
The trial will evaluate the safety and pharmacological profile of a single administration of nebulized AB569 in up to 25 healthy volunteers.
AB569 is made of ethylenediaminetetraacetic acid (EDTA) and sodium nitrite, two compounds approved by the U.S. Food and Drug Administration (FDA) for human use. AB569 was designed as a monotherapy, or to be used in combination with other compounds, to treat patients with reduced lung function due to multi-drug-resistant bacterial infections.
Specifically, the research team will evaluate the pharmacokinetics of exhaled nitric oxide — a naturally produced vasodilator — plasma nitrite and nitrate metabolites (produced by oxidation of nitric oxide), and circulating hemoglobin, which drives this oxidation and transports oxygen in the body. Pharmacokinetics refers to how a drug is absorbed, distributed, metabolized and expelled by the body.
The study also aims to assess the tolerance of nebulized AB569 in three increasing doses.
Arch Biopartners is now recruiting participants after delivering AB569 inhalation drug kits at the Cincinnati Veterans Affairs Medical Center (CVAMC), where the research will be conducted.
“[The study] is an important first step to establish AB569 as a non-antibiotic drug candidate for treating drug resistant bacterial infections in the lung,” Ralph Panos, MD, the trial’s lead investigator and chief of medicine at CVAMC, said in a press release. “AB569’s clinical impact in subsequent Phase 2 trials will depend on AB569’s safety profile in this first-in-human study at CVAMC.”
Pre-clinical studies showed that AB569 is able to kill drug-resistant bacteria like Pseudomonas aeruginosa and other pathogens associated with chronic lung infections. Infection with P. aeruginosa is common among CF, COPD, and pneumonia patients.
In order to speed up its development, the FDA granted AB569 orphan drug status in November 2015 as a treatment candidate for P. aeruginosa lung infections in CF patients.