
Biosynexus has three lead product candidates that use proprietary antibody, enzyme and peptide technologies. These products are focused on the prevention and treatment of multi-drug resistant staphylococcal infections.

Pagibaximab is a monoclonal antibody directed against lipotechoic acid (LTA), a key constituent of the cell wall of staphylococci. This candidate has shown promising results in preventing staphylococcal infections in a small phase 2 study in very low birth weight infants in the neonatal intensive care unit (Abstract). The company is currently enrolling in a large Phase 2b/3 study to confirm these results and to develop safety data that will be necessary to obtain regulatory approval (Clinical Trials).

Lysostaphin is a recombinant bacterial derived enzyme which destroys certain key chemical links in the cell walls of staphylococci, leading to rapid killing of both actively growing and quiescent bacteria. It is highly active against antibiotic sensitive as well as antibiotic resistant Staphylococcus aureus. Since lysostaphin kills staphylococci immediately upon contact it is unlikely that resistance development will become a limiting clinical problem. Furthermore, when lysostaphin is used together with a beta-lactam antibiotic, resistance to either lysostaphin or the antibiotic is precluded and their combined anti infective activity is enhanced. Unlike conventional antibiotics, lysostaphin retains it ability to kill staphylococci in the presence of a biofilm and completely disrupts staphylococcal associated bio-films.

Biosynexus has developed a topical antibiotic with nisin as one of the active components. Skin infection models in both mice and pigs demonstrate that this topical antibiotic has superior efficacy when compared to all other topical anti-infective formulations. In the pig model, which is widely regarded as the best comparator to human skin, the combination formula completely eradicated staphylococcal skin infections within one day whereas the individual components significantly reduced, but did not eradicate, infection by Day 5. Emergence of resistance to this product is expected to be rare because of the use of two agents with different mechanisms of action and because of the multi anti-bacterial actions of nisin.
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