Inhibitex says last patient enrolled in phase 3 trial for Veronate to prevent infections in premature infants

By E. Janene Geiss

Philadelphia, Nov. 16 - Inhibitex, Inc. said Wednesday that it completed enrollment of its 2,000-patient phase 3 clinical trial of Veronate for the prevention of hospital-associated infections in premature, very low birth weight infants.

Enrollment in the trial, which began in May 2004, was completed in less than 18 months and was conducted at 95 neonatal intensive care units (NICU) in the United States and Canada. No single NICU accounted for more than 4.5% of the total number of infants enrolled in the study, according to a company news release.

"To the best of our knowledge, this is the largest adequately powered, well-controlled phase 3 clinical trial conducted in the neonatal intensive care setting in nearly 15 years. We believe the large number and broad range of participating NICUs will strengthen the applicability of the results," said Seth Hetherington, vice president of clinical development and chief medical officer of Inhibitex, in a statement.

"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."

Veronate is a novel antibody-based investigational drug being developed to prevent hospital-associated infections in premature, very low birth weight infants.

The primary endpoint of the phase 3 trial is to demonstrate efficacy in the prevention of hospital-associated infections due to Staphylococcus aureus. Secondary endpoints include reduction in the frequency of hospital-associated infections due to Candida species (fungus) and Coagulase-negative staphylococci, and reduction in the mortality rate among these high-risk infants, officials said.

Veronate was granted both Fast Track designation and Orphan Drug status by the U.S. Food and Drug Administration. The company said it retained all rights to the drug and if approved, anticipates commercializing it independently in the United States.

Inhibitex, based in Alpharetta, Ga., is a biopharmaceutical company focused on discovery of antibody-based products for prevention and treatment of infections.

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