Arch Biopartners to Seek Regulatory Guidance From the U.S FDA for AB569

ARch Biopartners (TSXV:ARCH) has announced it will seek regulatory guidance from the US Food and Drug Administration in a pre investigational new drug application meeting for AB569, its drug candidate for treating antibiotic resistant bacterial infections in the lungs, wounds and urinary tract.

As quoted in the press release:

Arch began sponsoring an investigator initiated phase I study testing the safety of inhaled AB569 at the Cincinnati Veterans Affairs Medical Center (CVAMC) earlier this year. “We have decided with our clinical team that this is the best time to initiate dialogue with the FDA and complete the phase I 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 I trial for the FDA,” said Richard Muruve, CEO of Arch Biopartners.

The investigator-initiated phase I safety trial will thus be on hold and will resume again after the IND application is opened and the FDA approves the phase I study. So far, the data accumulated from the investigator initiated study at the CVAMC are insufficient at this time to make a reliable disclosure regarding the safety of AB569.

Click here to read the full press release.