Dalton, Arch Plan Joint Production of AB569 for Clinical Trials Involving Treatment-resistant Lung Infections

Dalton and Arch Biopartners are partnering to manufacture AB569 for clinical trials involving cystic fibrosis (CF) patients with chronic, antibiotic-resistant bacterial lung infections.

Under the agreement, the two will divide manufacturing tasks, including formulating the compound, putting it in containers safely, and doing quality-control testing.

The drug will be the key component of clinical kits required for a Phase 1 trial at the Cincinnati Veterans Affairs Medical Center (CVAMC). The study will evaluate AB569’s safety and pharmacokinetics, or how the drug behaves in the body.

Antibiotic resistance is one of the greatest threats to global health today. While some innovative antibiotics are under development, none seems to be effective against the most threatening forms of antibiotic-resistant bacteria.

AB569 is an inhaled treatment for mucoid and non-mucoid Pseudomonas aeruginosa pulmonary infections that are resistant to conventional antibiotics. It is a combination of two compounds, sodium nitrite and ethylenediaminetetraacetic acid.

Cystic fibrosis and chronic obstructive pulmonary disease (COPD) patients often development antibiotic-resistant bacterial lung infections. AB569 has proven effective against P. aeruginosa in preclinical-trail studies in labs and living organisms.

AB569 received orphan drug designation from the U.S. Food and Drug Administration in 2015 for treating P. aeruginosa lung infections in CF. Orphan drug status accelerates the FDA’s approval process so a therapy can serve populations with rare diseases.

The European Medicines Agency has also given AB569 its form of orphan drug status — orphan medicinal product designation — as a treatment for lung infections in CF.

“Dalton is privileged to be supporting this critical GMP campaign, and to play an important role in the development of this innovative antibiotic for the treatment of lung infections that affect millions of patients,” Peter Pekos, the company’s president and CEO, said in a press release. “The need for a new, effective treatment is very great; some pulmonary bacterial infections are resistant to all 26 antibiotics approved in the United States.”