Membership Directory - Companies
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MICROBION CORPORATIONMICROBION CORPORATION
Microbion is a clinical stage biotechnology company dedicated to the development of its proprietary antimicrobial, anti-biofilm bismuth-thiol (BT) family of compounds as therapeutic agents for the treatment of human infections, including those caused by antibiotic-resistant bacteria. We have successfully completed three Phase 1 clinical studies to evaluate the safety of our lead topical/local formulation (MBN-101) in normal human volunteers. Microbion filed a successful Investigational New Drug (IND) application with the FDA in June 2015 and in 2016 initiated an ongoing Phase 2b multi-center clinical study to evaluate the safety and efficacy of MBN-101 for the treatment of post-surgical orthopedic device-associated infections. A second ongoing multi-center clinical study to assess safety and efficacy of MBN-101 for treatment of moderate-to-severe diabetic foot ulcer infections was initiated in 2017. The FDA has granted Qualified Infectious Disease Product (QIDP) and Fast Track designations to MBN-101 for both of these clinical indications. Upon marketing approval, QIDP provides an additional five years of market exclusivity and Microbion is currently one of only two clinical-stage QIDP companies advancing an antimicrobial drug with a new mechanism of action. We have also initiated a pre-clinical program for development of an inhaled formulation for treatment of pulmonary infections.