Microbion Corporation (“Microbion”) of Bozeman, MT, USA and Microbion Pharma Corp. of Vancouver, BC, Canada, specializing in the treatment of hard to treat and antibiotic-resistant infections, announced that the U.S. FDA has granted MBN-101 Fast Track designation for adjunctive treatment of mild and moderate diabetic foot ulcer infections.
The Fast Track programs, under the Food and Drug Administration Modernization Act of 1997 (FDAMA), mandates the FDA to facilitate the development, and to expedite review of drugs and biologics intended to treat serious or life-threatening conditions that demonstrate the potential to address unmet medical needs.
The FDA granted this designation to MBN-101 following its review of data from the MBN-101 development program. The FDA assessed the product’s potential for the treatment of moderate and severe diabetic foot ulcer infections, and similarly, assessed MBN-101’s ability to qualify for Fast Track by addressing an unmet medical need in a serious or life-threatening condition. Earlier this year, the FDA had already granted Qualified Infectious Disease Product (QIDP) Designation to MBN-101 for this clinical indication.
“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.”
