Pipeline

Orthopedic-Implant Infection

Postoperative orthopedic infections, especially those caused by antibiotic-resistant organisms, present a significant clinical challenge for surgeons and treating physicians. These infections often involve surgically implanted orthopedic hardware, which can serve as a surface for persistent microbial biofilms to develop. Biofilm formation on implants makes infections notoriously difficult to eradicate and contributes to chronicity and increased resistance to treatment.

The standard of care for postoperative orthopedic infections typically includes surgical intervention, irrigation, debridement, and, when necessary, replacement of orthopedic hardware, combined with prolonged courses of systemic antibiotics (administered intravenously or orally). Despite these measures, outcomes are often poor and may include chronic or recurrent infections, repeated hospitalizations and surgeries, multiple courses of antibiotics, loss of function, disability, amputation, and even death. Bacteria can adhere to implanted materials almost immediately, leading to rapid biofilm formation that significantly increases bacterial resistance and infection persistence.

Antimicrobial-resistant pathogens are identified in 37.5–65.5% of postoperative orthopedic infections, further complicating management and outcomes. Staphylococcus aureus is the most common causative organism, followed by Pseudomonas aeruginosa, E. coli, and Enterobacteriaceae.

Our Solution

Locally administered pravibismane, formulated as a sterile hydrogel suspension, offers important potential advantages over current standard-of-care treatments for orthopedic infections. Applied directly to bone and exposed hardware during surgery, pravibismane’s dual antimicrobial and anti-biofilm effects are expected to enhance eradication of bacteria and biofilms at the infection site, compared to intravenous antibiotics alone. Effective local therapy may reduce the risk of treatment failure, repeat surgeries, additional systemic antibiotics, prolonged hospitalization, and increased morbidity and mortality.

Topical pravibismane has been granted Qualified Infectious Disease Product (QIDP) designation and Fast Track status by the US FDA for the adjunctive treatment of post-surgical implant infections.

MBN-101-201 Orthopedic Infection Study

A Phase 2a clinical study has been completed to assess pravibismane administered intraoperatively to osteosynthesis or osteomyelitis sites in patients with orthopedic infections, with or without implanted hardware. The primary objective was to evaluate the safety and tolerability of single escalating doses of locally administered pravibismane as an adjunct to standard antimicrobial and surgical therapy.

This randomized, single-blind, placebo-controlled, dose-escalation study evaluated a single intraoperative application of pravibismane plus standard of care versus placebo plus standard of care in 24 patients. Pravibismane was found to be safe and well-tolerated, with no pravibismane-associated Serious Adverse Events (SAEs) observed. Treatment-emergent adverse events were lower in all pravibismane-treated groups compared to placebo. Although the study was not powered to demonstrate statistical efficacy, a numerical reduction in treatment failure was observed in subjects treated with pravibismane.