Inhibitex has completed enrollment of its Phase II clinical trial of Veronate, an investigational drug for hospital-acquired staph infections in 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.
Inhibitex says the principal objectives of the study are to select an appropriate dose to advance into a Phase III trial, and obtain estimates of the incidence of hospital-acquired infections in the low birth weight infant population and the efficacy of Veronate in preventing these infections, particularly staphylococcal infections.
The Atlanta-based 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.
Inhibitex: www.inhibitex.com
