Inhibitex says infection treatment Veronate fails to meet endpoints in phase 3 trial

By E. Janene Geiss

Philadelphia, April 3 - Inhibitex, Inc. announced Sunday that Veronate failed to meet its primary endpoint in the company's phase 3 clinical trial for the prevention of hospital-associated infections due to Staphylococcus 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, according to a company news release.

"The outcome of the trial was unexpected against the background of our preclinical studies and favorable phase 2 trends such that additional scrutiny is warranted," William D. Johnston, president and chief executive officer of Inhibitex, said in the release.

The company said it plans to conduct further data analyses and laboratory studies to attempt to reconcile the phase 3 data with its prior results.

The company also said it will convene a panel of outside experts to review all findings related to the Veronate program.

Upon the completion of these assessments, the company said it will determine the appropriate next steps for Veronate.

Officials added that the company's plans for Aurexis remain unchanged at this time and it intends to begin a multi-dose safety and pharmacokinetic study in patients with S. aureus bloodstream infections pending final discussions with the Food and Drug Administration.

The pivotal phase 3 trial was a multi-center, placebo controlled, double-blind study comparing the safety and efficacy of Veronate to a 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 or a 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, a reduction in bloodstream infections caused by coagulase-negative staphylococci 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 FDA and Orphan Medicinal Product designation by the European Medicines Agency.

Inhibitex is an Alpharetta, Ga., biopharmaceutical company focused on the discovery, development and commercialization of antibody-based products for the prevention and treatment of serious, life-threatening infections.

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