Production of CF Therapy Candidate AB569 for Clinical Trials to Begin

Arch Biopartners and  Catalent Inhalation, a division of Catalent Pharma Solutions, have entered agreements to start manufacturing AB569 for human trials in patients with chronic and antibiotic resistant bacterial lung infections.

Representing a large part of the group affected, patients with cystic fibrosis  (CF) stand to benefit most. AB569, invented by Daniel Hassett, PhD, professor at the University of Cincinnati College of Medicine, has been developed and tested in partnership between Hasset’s team and Arch, which has held the exclusive license of the drug since April.

Last year, AB569 received orphan drug designation in the E.U. and U.S. for the treatment of CF. Orphan status is allows the drug to pass through regulatory, review, and approval processes faster and with less constraints in order to serve small populations impacted by rare diseases. 

The drug particularly targets the bacterium pseudomonas aeruginosa of which the mucoid form is difficult to treat with traditional drugs. Arch scientists believe that the two active ingredients in AB569, acidified nitrite and EDTA, boost the actions of each other so that the final result is better than expected from the two substances separate.

The drug will be developed as an inhaled solution. Catalent is currently developing studies to assess stability and formulation — the exact mix of active substance and other compounds that make up a drug.

After the initial studies are completed, and Arch and Catalent both satisfied with the product, Catalent will begin large-scale production of the drug.

“We are pleased to support Arch Biopartners’ program from our recently expanded facility in Morrisville, North Carolina, Catalent’s Centre of Excellence in the development and manufacture of inhaled dose forms,” said Jonathan Arnold, vice president and general manager for Advanced Delivery Technologies, said in a news release.

The drug has already gone through extensive pre-clinical tests showing that it is effective against P. aeruginosa and safe in animal disease models. Arch is engaged in the toxicology studies needed to file an Investigational New Drug Application with the U.S. Food and Drug Administration (FDA) for the first human trials. The news that the production of the drug is about to start indicates that studies are approaching the finish line.