Microbion is developing pravibismane for the treatment of resistant and difficult to treat infections. Pravibismane has antibacterial and anti-biofilm efficacy against a broad range of Gram-negative and Gram-positive pathogens, including multiple priority pathogens or “superbugs” as identified by the US Centers for Disease Control and Prevention (CDC). In commonly problematic drug-resistant bacteria, the antibacterial and anti-biofilm effect of pravibismane was demonstrated at equipotent concentrations.
Pravibismane is the first compound in a new class of microbial bioenergetic inhibitor agents. By disrupting energy flow in bacterial membranes, the resulting effect stops bacterial ATP production that subsequently halts all downstream biosynthetic activity such as DNA, RNA, protein, cell wall and lipid synthesis to the detriment of the offending pathogen. Pravibismane activity against pathogens is reversible and very low resistance potential has been demonstrated in multiple standard in vitro studies.
Microbion has successfully conducted three clinical studies with a topical/local suspension formulation of pravibismane, named MBN-101, in healthy volunteers and two clinical studies in patients with 1) diabetic foot ulcer infection; and 2) orthopedic implant infection. Additionally, pre-clinical 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.