AB569 is an investigational treatment that is in early-stage of development by Arch Biopartners for the treatment of respiratory infections caused by the bacteria Pseudomonas aeruginosa in patients with cystic fibrosis (CF) and chronic obstructive pulmonary disease (COPD).

CF is associated with abnormal mucus production in the lungs and airways, making the patients more prone to bacterial infections that result in a rapid decline in lung function. The lung infection in CF patients is related mostly to the mucoid form of the bacteria Pseudomonas aeruginosa, which is resistant to both antibiotics and immune attack.

In November 2015, the U.S. Food and Drug Administration (FDA) granted AB569 orphan drug designation for treating antibiotic-resistant Pseudomonas aeruginosa pulmonary infections in patients with CF. In April 2016, the treatment also received a positive opinion from the European Medicines Agency (EMA) for orphan designation as a treatment for lung infections in CF.

How AB569 works

AB569 works through a novel mechanism of action that is different from antibiotics. It consists of two primary active ingredients, sodium nitrite and ethylenediaminetetraacetic acid (EDTA), that boost each other’s action, resulting in the potent and synergistic killing of bacteria.

This two-component drug has the potential to kill both the mucoid and non-mucoid forms of Pseudomonas infections that are resistant to antibiotics. AB569 also has the potential to treat drug-resistant bacterial infections that develop due to other conditions, such as urinary tract infections.

It is administered as a nebulized solution, which means it is inhaled.

AB569 in clinical trials

Preclinical studies, both in vitro and in vivo, demonstrated the effectiveness of the components of AB569 against antibiotic-resistant bacteria such as Pseudomonas aeruginosa, Staphylococcus aureus, and Burkholderia cepacia that commonly infect the lungs of patients with CF. In these studies, AB569 killed bacteria without causing any harm to human cells. In addition, these bacteria were unable to develop resistance against AB569.

Arch Biopartners plans to initiate a Phase 1 study to evaluate the safety and pharmacokinetic profile (movement in the body) of AB569. It has partnered with Dalton Pharma Services to produce three dose formulations of AB569 for the study, which aims to determine the safety and tolerability of nebulized AB569 in three escalating doses of acidified sodium nitrite and EDTA in healthy individuals. The study also will evaluate the pharmacokinetics of plasma nitrite and nitrate metabolites, exhaled nitric oxide, and circulating hemoglobin. It will be conducted at the Cincinnati Veterans Affairs Medical Center.

If the results from this Phase 1 trial are positive, they may lead to a Phase 2 trial that will evaluate the effectiveness of AB569 in patients with COPD who have P. aeruginosa infections.

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