SelectImmune Pharma reported that the Phase II trial of the IL-1 receptor antagonist (IL-1RA) in patients with recurrent acute cystitis has started. The clinical trial is led by Professor Wagenlehner, an international key opinion leader in the field of urinary tract infection therapy and antibiotic resistance at the center for such studies in Giessen, Germany, in collaboration with scientists at Lund University and SelectImmune. The formal clinical trial preparations to obtain permission for the study from the German regulatory authorities and ethical committee have been completed and the study organization finalized, including preparations for patient enrolment and laboratory analyses. The initiation procedure, involving physicians, monitors, other clinical staff and laboratory staff, is required to start a clinical trial was recently completed. The aim of the study is to evaluate the efficacy of IL-1RA treatment in patients with recurrent episodes of acute cystitis. The study is based on the scientific discovery that acute cystitis is an interleukin-1ß hyper-activation disorder, triggered byinfection of the bladder. Characteristic symptoms include urgency, frequency of urination and pain. The therapeutic efficacy of IL-1 receptor inhibition, first demonstrated in susceptible mice, is now tested in the clinic. Since IL-1RA is registered for other clinical indications, SelectImmune Pharma has the permission to perform a Phase II trial. Acute cystitis is one of the most common bacterial infections and increasingly difficult to treat, due to antibiotic resistance. Targeted immunotherapy offers an important new molecular strategy to treat these infections, with the potential of reaching very large patient groups. Importantly, immunotherapy has shown effects against both antibiotic sensitive and antibiotic resistant bacteria in an animal model.