BOZEMAN, MT, and VANCOUVER, BC--(Marketwired - August 04, 2016) - 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, 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.
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. Fast Track expedites the review of drugs and makes available the possibility of a "rolling review" of a drug application in addition to potential other advantages. An important feature of Fast Track is that it emphasizes and enables early and more frequent communications between the FDA and the Fast Track sponsor pharmaceutical company, to improve the efficiency of product development. 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."
About Microbion Corporation
Microbion is a clinical-stage biopharmaceutical company. Microbion is developing MBN-101 as the first product in a new class for the treatment of antibiotic-resistant and difficult to treat infections. MBN-101 has broad spectrum, antibacterial efficacy against a broad range of pathogens, including multiple priority pathogens or "superbugs". In addition to antibacterial efficacy, MBN-101 has also demonstrated the ability to eradicate microbial biofilms. This dual antimicrobial action from this first-in-class product provides a novel clinical approach to treating infections. Microbion filed an IND in the United States for MBN-101 in 2015. The company initiated its first Phase 2a study in 2016. MBN-101 has been granted Qualified Infectious Disease Product (QIDP) designation by the FDA for treatment of post-surgical orthopedic implant infections and was also granted Fast Track status for this indication by the FDA in 2015. The company has also been granted QIDP and Fast Track Designations by the FDA for adjunctive treatment of moderate and severe diabetic foot infections.
About Chronic Wound Infections, Including Diabetic Foot Ulcer Infections
Chronic wounds are wounds which have failed to heal effectively and in a timely manner. Chronic wounds affect approximately six million patients in the United States on an annual basis. The most common risk factors for developing chronic wounds include diabetes, vascular disease, and obesity. Bacterial infection and microbial biofilms are considered one of the main causes of impaired healing in chronic wounds. The most common chronic wound types are diabetic foot ulcers, venous leg ulcers and pressure ulcers. Chronic wounds represent a significant burden to patients, healthcare professionals and the U.S. healthcare system, costing an estimated $25 billion dollars annually. There are over 70,000 amputations annually on diabetic patients in the United States and 80% of diabetic amputations are preceded by an ulcer. There are over 100,000 hospitalizations in the U.S. annually for diabetic foot ulcers.
About Orthopedic Device Related Infections
There were over 2 million device-related orthopedic surgeries in the United States in 2015. There are also approximately 1 million traumatic fractures, in the United States annually. The infection rate related to the above conditions/surgeries can reach up to 20% in patients with risk factors including obesity, diabetes, and smoking, with significant patient morbidity and economic burden to the healthcare system. The cost of infected hip and knee replacements alone is projected to be over $1 billion annually in the United States.
Safe Harbor Statement
Certain of the statements made in this press release are forward-looking, such as those, among others, relating to the success of clinical development of MBN-101 and preparation for potential commercialization. These statements are subject to risks and uncertainties that could cause actual results and events to differ materially from those anticipated, including, but not limited to, risks and uncertainties related to: our ability to enroll patients in our clinical trials at the pace that we project; the size and growth of the potential markets for MBN-101 or any future product candidates and our ability to serve those markets; our ability to obtain and maintain regulatory approval of MBN-101 or any future product candidates; and our expectations regarding the potential safety, efficacy or clinical utility of MBN-101 or any future product candidates. Actual results or developments may differ materially from those projected or implied in these forward-looking statements. Microbion Corporation disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.