Pipeline

About Pravibismane

Microbion is developing pravibismane to address resistant and difficult-to-treat infections, as well as chronic or dysfunctional inflammation. These conditions often occur together, making effective treatment especially challenging. Pravibismane’s unique capabilities enable the simultaneous treatment of both infection and aberrant inflammation with a single, locally administered agent, without the systemic risks commonly associated with many systemically administered drugs. 

Pravibismane demonstrates potent antibacterial and anti-biofilm activity against a broad spectrum of Gram-negative and Gram-positive pathogens, including multiple priority “superbugs” identified by the US Centers for Disease Control and Prevention (CDC). Its antibacterial and anti-biofilm efficacy has been shown at equipotent concentrations in drug-resistant bacteria, and it has exhibited extremely low potential for the development of resistance in numerous in vitro studies. 

Pravibismane is the first compound in a new class of microbial bioenergetic inhibitors. By disrupting energy flow in bacterial membranes, pravibismane halts ATP production, thereby stopping all downstream biosynthetic activities—such as DNA, RNA, protein, cell wall, and lipid synthesis—leading to rapid bacterial death.

Pravibismane has also demonstrated potent activity against antibiotic-resistant and multidrug-resistant pathogens, including those encountered in human clinical studies. Its unprecedented ability to prevent and eradicate biofilms addresses a major factor in chronic and persistent infections.

Microbion has completed six clinical studies with a topical/local suspension formulation of pravibismane, including studies in healthy volunteers, two clinical trials in patients with diabetic foot ulcer infections, and one in patients with orthopedic implant infections. Additionally, preclinical programs are complete for multiple therapeutic indications, including serious respiratory infections. (In early studies, pravibismane was referred to as MBN-101.)

Pravibismane has been granted Qualified Infectious Disease Product (QIDP) and Fast Track designations 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.  QIDP designation provides five years of additional market exclusivity beyond Hatch-Waxman exclusivity and makes pravibismane eligible for further incentives, including priority review. Fast Track designation may expedite the New Drug Application (NDA) submission and review process. Pravibismane has also received Orphan Drug designations for the management of cystic fibrosis-related lung infections and for nontuberculous mycobacterial infections, including all infection locations such as the lung and soft tissue.