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No Measurable Effects Reported for Veronate in Phase 3 Trial for <i>Staphylococcus Aureus </i>
"The outcome of the trial was unexpected against the background of our preclinical studies and favorable Phase II trends such that additional scrutiny is warranted," stated William D. Johnston, Ph.D., president and chief executive officer of Inhibitex. "We plan to conduct further data analyses and laboratory studies to attempt to reconcile the Phase III data with our prior results. In addition, we will convene a panel of outside experts to review all findings related to the Veronate program. Upon the completion of these assessments, we will determine the appropriate next steps for Veronate. Further, our plans for Aurexis® remain unchanged at this time, and we intend to initiate a multi-dose safety and pharmacokinetic study in patients with S. aureus bloodstream infections pending final discussions with the FDA."
The Company also reported that the observed event rate for the primary endpoint was consistent with the assumptions used to design and power the trial. Additionally, there were no significant differences in frequencies of adverse events between the treatment and placebo groups.
The pivotal Phase III trial was a multi-center, placebo controlled, double-blind study comparing the safety and efficacy of Veronate to placebo for the prevention of S. aureus bloodstream infections in premature infants. Infants with birth weights between 500 and 1,250 grams were randomized with equal probability to receive either Veronate (750 mg/kg) or placebo in a series of up to four intravenous infusions administered at intervals over the first two to three weeks of life. The trial enrolled 2,017 infants across 95 neonatal intensive care units across the United States and Canada. Infants were followed for up to 70 days, or until discharge from the hospital.
The primary endpoint of the trial was to demonstrate efficacy in the prevention of hospital-associated bloodstream infections due to S. aureus in these premature infants. Secondary endpoints included a reduction in the frequency of bloodstream infections caused by Candida species (fungi), a reduction in bloodstream infections caused by coagulase-negative staphylococci (CoNS), and a reduction in all-cause mortality.
Veronate, a novel, antibody-based investigational drug being developed to prevent hospital-associated infections in premature infants, is the Company's most advanced product candidate. Veronate has been granted both Fast Track designation and Orphan Drug status by the United States Food and Drug Administration (FDA) and Orphan Medicinal Product (OMP) designation by the European Medicines Agency (EMEA).
Source: Inhibitex, Inc.