Microbion is developing MBN-101 as the company’s first product for the treatment of resistant and difficult to treat infections. MBN-101 has antibacterial efficacy against a broad range of Gram-positive and Gram-negative pathogens, including multiple priority pathogens or “superbugs” as identified by the US Centers for Disease Control and Prevention (CDC). Microbion has two Phase 2 clinical programs ongoing. Additionally, preclinical programs are under development for multiple therapeutic indications, including the treatment of serious respiratory infections.
MBN-101 has been granted Qualified Infectious Disease Product (QIDP) designation and Fast Track designation by the US FDA for: (1) adjunctive treatment of moderate and severe diabetic foot ulcer infection; and (2) treatment of post-surgical orthopedic implant infections. The QIDP designation provides five years of market exclusivity in addition to Hatch-Waxman exclusivity and allows MBN-101 to be eligible for additional incentives for product approval and marketing including priority review. Fast Track designation may expedite the NDA (New Drug Application) submission and review process.