Microbion Corporation Announces FDA Has Granted Fast Track Designation to MBN-101 for the Adjunctive Treatment of Moderate and Severe Diabetic Foot Ulcer Infections
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 […]
BOZEMAN, MT, and VANCOUVER, BC–(Marketwired – June 16, 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 James Krieg, M.D., of Thomas Jefferson Hospital in Philadelphia, Pennsylvania, has enrolled the first patient in the […]
Microbion Granted Qualified Infectious Disease Product (QIDP) Designation for Adjunctive Treatment of Moderate and Severe Diabetic Foot Infections From U.S. FDA for MBN-101
BOZEMAN, MT and VANCOUVER, BC–(Marketwired – May 26, 2016) – Microbion Corporation (“Microbion”) of Bozeman, MT, USA and Microbion Pharma Corp. of Vancouver, BC, Canada, today announced that the U.S. Food & Drug Administration (FDA) has granted MBN-101, Microbion’s lead compound, Qualified Infectious Disease Product (QIDP) designation for the adjunctive treatment of moderate and severe diabetic foot infections. The QIDP designation program was established by the U.S. Congress in 2012 as part of the Generating Antibiotic Incentives Now (GAIN) Act in order to provide incentives to drug manufacturers to develop new antibiotics for serious, antibiotic-resistant, bacterial and fungal infections.[….]
Microbion Corporation is dedicated to safeguarding human health by overcoming infections, antibiotic resistance, and microbial biofilms with safe, effective anti-infective products.
Microbion is a clinical stage biopharmaceutical company. Microbion is developing MBN-101 as the first product in the bismuth-thiol class for the treatment of resistant and difficult to treat infections. MBN-101 has broad spectrum, anti-bacterial efficacy against a broad range of pathogens, including multiple priority pathogens or “superbugs”. In addition to anti-bacterial efficacy, MBN-101 also has highly advantageous and product-differentiating capability to prevent and eradicate microbial biofilms. The dual action from this first in class product provides a novel clinical approach to treating infections. Their effectiveness against MRSA, MDR TB, CRE, VRE, and other antibiotic resistant pathogens highlights their potential to provide solutions to the dramatic and alarming increase in global antibiotic resistance.
- Microbion filed an IND in the United States for MBN-101 in 2015.
The company initiated its first Phase 2a study directed at treatment of serious, life or limb threatening infections associated with orthopedic implants and chronic wounds in 2016.
- MBN-101 has been granted FDA Qualified Infectious Disease Product (QIDP) status for orthopedic device-related infections and was also granted Fast Track status for this indication in 2015 – – a designation that is anticipated to facilitate regulatory development and extend market exclusivity.
- Pre-clinical studies directed at the development of new antimicrobial/antibiofilm therapies for serious lung infections, systemic infections and for biodefense are underway or in the planning stages.