You are here

No Measurable Effects Reported for Veronate in Phase 3 Trial for <i>Staphylococcus Aureus </i>

ATLANTA, April 3 /PRNewswire-FirstCall/ -- Inhibitex, Inc. (Nasdaq: INHX - News) today announced that Veronate® failed to meet its primary endpoint in the Company's Phase III clinical trial for the prevention of hospital-associated infections due to Staphylococcus aureus (S. aureus) in premature infants weighing between 500 and 1,250 grams at birth. The Company further reported that there were no measurable effects or trends in favor of Veronate for the primary or any of the secondary endpoints.

"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.

About Veronate
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.

Recent Headlines

WHO to meet tomorrow to decide on international public heath emergency declaration
Study of posted prices finds wild variations and missing data
Potential contamination could lead to supply chain disruptions
Despite older, sicker patients, mortality rate fell by a third in 10 years
Study finds fewer than half of trials followed the law
Declining lung cancer mortality helped fuel the progress
Kinase inhibitor targets tumors with a PDGFRA exon 18 mutation
Delayed surgery reduces benefits; premature surgery raises risks
Mortality nearly doubled when patients stopped using their drugs