Clostridium difficile antibodies: A patent evaluation (WO2013028810)

Introduction: Incidence and severity of Clostridium difficile infection (CDI) are increasing worldwide. Toxins A (TcdA) and B (TcdB) and host immune response are the major determinates of CD pathogenesis and represent a new, stimulating therapeutic target to control CDI. Areas covered: The present patent and literature on the pathogenesis and treatment of CD were critically reviewed. The patent was described and put into clinical context, highlighting possible advantages and barriers to use. It consists of a blend of monoclonal antibodies (mAbs) and antigen-binding portions that neutralize TcdA, targeting the enterocyte-binding domain. It demonstrated good efficacy in in vivo models and seems promising in clinical practice. However, recent evidence reshaped the central role of TcdA. Expert opinion: Current treatments are inadequate to control CDI and recurrence. Toxin-targeted mAbs are one of the most promising approaches for CDI, including infection by hypervirulent strains. At-risk subjects and those experiencing recurrence are the ideal targets for this second-line treatment; however CDI epidemiology is fast-changing and mAbs may represent a powerful option also for other patients. The re-evaluation of the pathogenic role of TcdA may potentially limit the use of this product; however, the possible administration in combination with other therapeutic agents may optimize its efficacy. © 2013 Informa UK, Ltd.