Enrollment in the trial, which began in late May 2004, was completed in less than 18 months. The trial is being conducted at 95 neonatal intensive care units in the US and Canada.
The primary endpoint of the pivotal phase III trial is to demonstrate efficacy in the prevention of hospital-associated infections due to staphylococcus aureus. Secondary endpoints include a reduction in the frequency of hospital-associated infections due to candida species (fungus) and coagulase- negative staphylococci, and a reduction in the mortality rate among these high-risk infants.
“We are very pleased to have completed enrollment ahead of our initial time estimate,” stated Dr Seth Hetherington, chief medical officer of Inhibitex. “Based on the 70-day follow up period for the last baby enrolled, we continue to expect to be able to report top line data from this trial in the second quarter of 2006.”
The FDA has granted Veronate both Fast Track designation and Orphan Drug status.