Patent evaluation of US2019338018 (A1) 2019-11-07 (antibody fragments for the treatment of biofilm-related disorders)

Introduction: To date, microbial infections are also difficult to eradicate due to the increasing capability of bacteria to form a biofilm. In the era of antibiotic resistance, antibody-based approaches represent great promise in curing infective pathogens. The authors of US2019338018 patent propose a method for the treatment of biofilm-related disorders by using specific antibody fragments. Areas covered: The US2019338018 patent reports antibody fragments, pharmaceutical composition that contains it, and their application for the treatment of biofilm-linked disorders. Proof concept and preclinical results show that mAb mIhfB4NTHI Fab caused robust eradication of the biofilm in the middle ear lumen of chinchillas affected by Hemophilus influenzae infection. Expert opinion: Fab fragments of the US2019338018 patent are new in a general concept to treat bacterial biofilms and biofilm-linked disorders. However, pre-clinical data are only shown for the treatment with Fab fragments of infections caused by H. influenzae in the middle ear of chinchillas. There are no clinical trials that demonstrate that the treatment with Fab fragments may induce a disruption of biofilm produced by H. influenzae or other pathogens and an anti-inflammatory response in infected patients.