Arch Biopartners Inc (Arch), recently announced that its drug candidate AB569, which is being developed as treatment for pulmonary Pseudomonas aeruginosa infections, has successfully concluded pre-clinical in vivo and in vitro validation trials. The news is significant to the CF community due to the prevalence of P. aeruginosa in those with the disease, and the need to constantly and effectively treat the infection.
In all of the company’s pre-clinical trials, the drug was found to be effective against P. aeruginosa. These results also include a recent trial in a pulmonary infection mouse model.
The company believes that these new pre-clinical findings provide scientific evidence to initiate a study in humans to assess the efficacy and safety of AB569 in patients with Cystic Fibrosis infected with P. aeruginosa. Arch is now assessing the appropriate regulatory and toxicology methodology for the first human clinical trial for AB569. More details about these studies’ results will be disclosed in the coming months in an academic publication.
P. aeruginosa is a cause of bacterial respiratory infections in patients with CF, pneumonia or chronic obstructive pulmonary disease (COPD, and there is an urgent, ongoing need for new treatments. In the US, there are about 40,000 patients diagnosed with CF and about 14 million individuals have a diagnosis of COPD. Estimates indicate that every year 2 to 3 million individuals in the US are diagnosed with pneumonia.
The mucoid form of P. aeruginosa, frequently found in patients with CF, is a complex and challenging infection to treat because it has a high resistance to antibiotics and phagocyte-mediated killing. There is a rapid lung function decline and poor prognosis in patients with the mucoid form of P. aeruginosa.
Arch indicates that it is vital to find a clinical solution, and to develop new effective treatments for these patients. AB569 is a novel potential drug agent that works as treatment for mucoid and nonmucoid P. aeruginosa infections that are resistant to traditional antibiotics. If human clinical trials continue to reveal the therapy safety and efficacy, it could someday be a viable treatment for P. aeruginosa in cystic fibrosis.