ATLANTA, Georgia. – November 24, 2003 – Inhibitex, Inc. announced today that it has completed enrollment of its Phase II clinical trial of Veronate®, an investigational drug being developed for the prevention of hospital-acquired staphylococcal infections in very low birth weight infants. A total of 512 infants, weighing between 500 and 1,250 grams at birth, have been enrolled into the trial at 46 participating neonatal intensive care units in the United States. The principal objectives of the study are to select an appropriate dose to advance into a Phase III trial, and obtain estimates of (i) the incidence of hospital-acquired infections in the very low birth weight infant population and (ii) the efficacy of Veronate® in preventing these infections, particularly staphylococcal infections. The company also indicated it has scheduled a meeting with the FDA in December to discuss data from this study and its strategy for advancing Veronate® into a Phase III trial early next year.
Veronate® is a novel, antibody-based investigational drug being developed to prevent both Staphylococcus aureus (S. aureus) and Staphylococcus epidermidis (S. epidermidis) infections in very low birth weight infants. While in the neonatal intensive care unit, approximately one-third of these infants will acquire an infection, the majority of which are caused by staphylococcal organisms. In addition to increasing the mortality rate among these infants, hospital-acquired infections have also been shown to extend their already lengthy stay in the neonatal intensive care unit by an average of almost three weeks. Veronate® has been both designated as a Fast Track product and has been granted Orphan Drug status by the FDA.
Source: Inhibitex, Inc.