The study compared Aurexis plus antibiotic therapy to antibiotic therapy alone. Favorable results were observed in the primary composite endpoint of mortality, relapse rate and infection-related complications, and a number of secondary endpoints, including the progression in the severity of sepsis and days in the intensive care unit.
More specifically, there were four deaths in the group that received antibiotics alone, while in the group that also received Aurexis, there was one death and one relapse of infection.
Comparison of adverse events and laboratory values between the groups demonstrated that Aurexis was generally safe and well tolerated in this patient population. Two serious adverse events were considered possibly related to Aurexis by study investigators, but a review by an independent data safety monitoring board found no serious safety issues.
Based on the results of this 60-patient trial, Inhibitex intends to advance Aurexis into an appropriately powered, follow-on phase II trial in this indication.
“New treatment options are critically needed to manage increasingly aggressive and drug-resistant staph infections. The data from this clinical trial show that additional studies of Aurexis as a potential treatment are warranted,” stated Dr John Weems, an infection disease specialist at the Greenville Hospital System and principal investigator of the phase II trial.