AB569, Arch Biopartners’ lead therapy candidate, has received a U.S. patent for the treatment of chronic lung infections in patients with chronic obstructive pulmonary disease (COPD) or cystic fibrosis.
Patent 9,925,206 was issued by the U.S. Patent and Trademark Office to the University of Cincinnati, which previously granted an exclusive commercial license to Arch Biopartners on all patents related to AB569. Titled “Compositions and Methods for Treating Bacterial Infection,” the patent protects the therapy’s composition and methods of use as an antibacterial agent.
“This patent issuance gives Arch a stronger commercial position to pursue treating not just CF patients, but also the millions of other patients that have chronic antibiotic resistant lung infections including those with COPD,” Richard Muruve, CEO of Arch, said in a press release. “It also opens the door for Arch to develop treatments for many other indications where antibiotic resistance is a problem, such as urinary tract infections and wound care.”
AB569 is composed of acidified sodium nitrite and EDTA, which, when combined, have shown increased potential to kill several types of antibiotic-resistant bacteria that can cause lung infections.
“AB569 has two active ingredients that produce a dramatic and synergistic effect at killing many antibiotic resistant bacteria including Pseudomonas aeruginosa (P. aeruginosa), which commonly causes severe chronic infections in the lungs of cystic fibrosis (CF) and chronic obstructive pulmonary disease (COPD) patients. AB569 has the potential to make a significant medical impact on treating infection where traditional antibiotics fail,” said the therapy’s inventor, Daniel Hassett, MD, PhD, a professor at the UC College of Medicine and a researcher at Arch.
The safety and tolerability of a single administration of nebulized AB569 is currently being tested in a Phase 1 clinical trial in up to 25 healthy volunteers. The study is being conducted at the Cincinnati Veterans Affairs Medical Center (CVAMC) in collaboration with Arch, under the supervision of Ralph Panos, MD, chief of medicine at CVAMC and world-renowned COPD expert.
Following the successful completion of this study, researchers are planning to start a Phase 2 trial to continue to evaluate AB569. It will be conducted at CVAMC in collaboration with the University of Cincinnati College of Medicine, and will assess AB569’s potential to treat lung infections caused by P. aeruginosa and other bacteria in COPD and/or cystic fibrosis patients.
AB569 has been granted orphan drug status by the U.S. Food and Drug Administration to treat P. aeruginosa infections in cystic fibrosis patients. It also received orphan medicinal product designation by the European Medicines Agency for the general treatment of the disease.