The study was designed to assess the safety of a single treatment with efficacy parameters recorded as secondary variables. AM-Pharma is developing a unique therapy against sepsis, based on detoxification of the bacterial endotoxin LPS. This is an early mediator in the sepsis cascade, and one of the highest possible upstream targets, and therefore a promising approach for the development of a successful therapy.
Dr Bruno Giannetti, president chief executive of AM-Pharma said: “These are very promising data, although obtained in relatively small patient numbers, particularly when considering the fact that the dose and the treatment schedule still needs to be optimized. We are now in the process of planning a dose finding pivotal trial to optimize the dosing regime and demonstrate the efficacy of the drug.”
The treatment was well tolerated. The primary aim of the study was to assess safety of the treatment. Next to serious adverse events, 28 and 90 days survival rates were recorded. No drug-related serious adverse events were reported in the Verum group. The reduction of the mortality risk due to sepsis is represented by the calculated absolute and relative risk reduction. After 28 days, the Verum group showed 12.4% absolute risk reduction and 34% relative risk reduction. After 90 days absolute risk reduction was 17.5% and relative risk reduction was 38.4%.