AM-PHARMA ANNOUNCES POSITIVE RESULTS FROM SEPSIS TRIAL

AM-Pharma has announced the first positive results observed in its multicenter, double-blind, placebo-controlled pilot study in the treatment of sepsis with its patented alkaline phosphatase (AP) drug, Verum. The study was conceived as a pilot clinical study to assess safety of a single treatment with AP in patients suffering from severe sepsis. At the same time efficacy parameters were recorded as secondary variables.

AM-Pharma is developing a unique therapy for 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, according to the company.

A total of 36 patients admitted to intensive care units with the diagnosis of severe sepsis were included in the study. The treatment consisted in a bolus of 67.5 U/kg infusion in the first 10 minutes followed by a nearly 24-hour infusion of 132.5 U/kg.

The primary aim of the study was to assess safety of the treatment. Adverse events and 28- and 90-day survival rates were recorded. The treatment was well-tolerated. 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 percent absolute risk reduction and 34 percent relative risk reduction. After 90 days, absolute risk reduction was 17.5 percent and relative risk reduction was 38.4 percent.