ATLANTA -- Inhibitex, Inc. today reported top-line findings from its Phase II clinical trial of Aurexis for the adjunctive treatment of serious, life threatening Staphylococcus
aureus (S. aureus) bloodstream infections in combination with antibiotics.
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 (ICU). The study compared Aurexis plus antibiotic therapy to antibiotic therapy alone. Based on the results of this 60-patient trial, the company intends to advance Aurexis into an appropriately powered, follow-on Phase II trial in this indication.
The patient group that also received Aurexis experienced a lower incidence of mortality or other severe complications, as measured by the primary endpoint. Four patients in the group that received antibiotics alone met the primary composite endpoint, compared with two in the group that also received Aurexis. More specifically, there were four deaths in the group that received antibiotics alone; in the group that also received Aurexis there was one death and one relapse of infection. The other primary objectives of the study were pharmacokinetics (PK) and safety. The PK profile indicated that the plasma levels of Aurexis were lower than those observed in healthy subjects in an earlier Phase I trial. 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; however a review by an independent data safety monitoring board found no serious safety issues. Among the secondary endpoints, progression in severity of sepsis was
observed in four patients in the group that received antibiotics alone and none in the group that also received Aurexis. Total hospital days were similar for both groups of patients; however of those patients admitted to the ICU, the median duration of stay in the ICU was seven days for patients who received antibiotics alone compared to three days for patients who also received Aurexis.
Although not prospectively described in the study endpoints, the company also reported that of the patients who received antibiotics alone, nine experienced a candida infection, compared to three among those who also received Aurexis. In addition, fewer patients receiving Aurexis plus antibiotics were nasally colonized with S. aureus at the end of the study compared to patients who received antibiotics alone.
"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. J. John Weems, an infection disease specialist at the Greenville Hospital System and principal investigator of the Phase II trial.
"The results of this trial are highly encouraging to us and our clinical
investigators on a number of fronts, and in our opinion, further validate the
utility of our MSCRAMM protein platform in preventing and treating serious,
life-threatening bacterial and fungal infections," stated William D. Johnston,
CEO and president of Inhibitex, Inc. "The trial accomplished its objective
for us. The top-line data is positive and provides the information we need to
move forward and design a larger, well-powered Phase II clinical trial for
Aurexis in S. aureus bloodstream infections. We believe reducing mortality
and the progression of sepsis in patients with these serious infections are
meaningful clinical endpoints, and that decreasing the number of days these
patients spend in the ICU can provide a significant pharmacoeconomic benefit
to our hospitals and healthcare system. The lower rate of candida infections
in patients that also received Aurexis in this trial is also of great interest
to us, as we saw a similar trend in the prevention of candida infections in
our Phase II trial of Veronate in very low birth weight neonates."
Source: Inhibitex, Inc.