Canadian biotech Arch Biopartners has announced that it will put an ongoing Phase 1 safety study of its AB569 ethylenediaminetetraacetic acid (EDTA)/sodium nitrite bactericidal inhalation solution on hold and will ask the FDA for a pre-IND meeting for AB569. The study began recruiting volunteers in February 2018.
Arch Biopartners CEO Richard Muruve said, “We have decided with our clinical team that this is the best time to initiate dialogue with the FDA and complete the Phase 1 study under an open IND application. Since our ultimate goal is to obtain drug approval and treat patients who are battling antibiotic resistant bacterial infections, starting the regulatory process now will help us make the most of our resources and avoid having to repeat a Phase 1 trial for the FDA.”
The company said that it plans to re-start the Phase 1 trial after getting approval for the study from the FDA.
Read the Arch Biopartners press release.
