Arch Biopartners has announced that Dr. Ralph Panos of the Cincinnati Veterans Affairs Medical Center (CVAMC) will prepare a protocol for human trials of the company’s AB569 inhaled bactericide and will subsequently prepare an application to conduct the trials.
The company expects that the application will be submitted to the IRB of the CVAMC by December 2016, with approval and a Phase 1 trial planned for January 2017. Arch added that it plans to initiate a Phase 2 study in COPD patients immediately following successful completion of the Phase 1 study,
Arch CEO Richard Muruve commented, “We are excited to support Dr. Panos and his team to prepare an application to perform the first human trials for AB569, which we believe will validate the clinical potential of AB569 and may provide an accelerated route toward a New Drug Application with the FDA.”
The company, which previously announced that Catalent Pharma Solutions will manufacture clinical trial supplies of AB569, says that preparations by Catalent are expected to be completed in time for initiation of the first trial in January 2017.
Read the Arch Biopartners press release.