Veronate® failed its 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). This news was announced recently by Veronate®'s maker, Inhibitex, Inc.
Veronate® is Inhibitex, Inc.’s novel antibody-based investigational drug being developed to prevent hospital-associated infections in premature infants which has been granted both Fast Track designation and Orphan Drug status by the USFDA and Orphan Medicinal Product (OMP) designation by the European Medicines Agency (EMEA).
"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®.
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