Gram-negative bacteria release lipopolysaccharide (endotoxin) that causes sepsis and septic shock. Monoclonal antibodies against endotoxins have been proposed as a treatment of sepsis. One such antibody, nebacumab (HA-1A), was released onto the market in some European countries and its approval in the USA was recommended.
However, doubts raised by the lack of reproducible preclinical data, and by an independent reanalysis of the results of the first clinical trial, led to a further clinical trial. This second trial revealed an increase in mortality in nebacumabtreated patients. The trial was stopped and the drug withdrawn from the market.
To avoid such disappointments, the marketing of new biotechnology products should be based on critical scientific analysis, free from commercial pressures, of thorough, reproducible and consistent preclinical and clinical studies.