The Orphan Drug Designation has been granted for the combination of two active ingredients of AB569: sodium nitrite and ethylenediaminetetraacetic acid. AB569 is to be administered to patients as a nebulized (inhaled) solution. AB569 was invented at the University of Cincinnati in the lab of Dr. Daniel Hassett.
Arch Biopartners CEO Richard Muruve said: "This Orphan Drug Designation from the FDA supports our effort to advance AB569 as a potential treatment for P. aeruginosa lung infections in patients with cystic fibrosis.
"The designation also complements a strong patent position for this new biocide drug treatment. We are currently finalizing the manufacturing and toxicology requirements for AB569 in order to prepare an Investigational New Drug application."
The FDA Office of Orphan Products Development grants Orphan Drug Designation to drugs and biologics to encourage the development of new medicines for the safe and effective treatment of underserved, rare diseases or disorders that affect less than 200,000 patients in the U.S.
The Orphan Drug Designation qualifies Arch for a seven-year term of market exclusivity to sell AB569 in the U.S. following FDA approval of the drug. Additionally, as Arch takes AB569 through the regulatory and human trial process, the Orphan Drug Designation provides an accelerated review and approval process, potential grant funding, tax benefits and an exemption from certain user fees.
"AB569 has a dramatic and synergistic effect at killing P. aeruginosa both in vitro and in vivo, including antibiotic-resistant strains," said Dr. Hassett.
"The individual active ingredients of the drug have been approved as safe for use in humans in the past. Our team at the University of Cincinnati looks forward to working with Arch to advance AB569 into clinical trials for cystic fibrosis patients who urgently need more effective treatments for their P. aeruginosarespiratory infections."