3 August 2016 - Microbion today announced that the U.S. FDA has granted MBN-101 fast track designation for adjunctive treatment of mild and moderate diabetic foot ulcer infections.
"Microbion is very pleased to have received fast track designation from the FDA for adjunctive treatment of moderate to severe diabetic foot ulcer infections," said Karim Lalji, Chairman and CEO of Microbion Pharma Corp. "We believe that faster review time and increased communication with the FDA on our development program will better serve the interests of patients in a disease area with high unmet medical need. It is our view that MBN-101, with its broad spectrum antibacterial profile and the ability to eradicate bacterial biofilms, will provide a much needed, novel approach to treating patients with diabetic foot ulcer infections. We are looking forward to initiating a safety and efficacy study of MBN-101 in moderate to severe diabetic foot ulcer infections in Q4-2016."