Inhibitex's safety board recommends completion of Veronate phase 3 trial

By Angela McDaniels

Seattle, Dec. 5 - Inhibitex Inc. said its independent Data Safety Monitoring Board unanimously recommended that the company's 2,000-patient, phase 3 clinical trial of Veronate should be completed without modification.

The conclusion came from the scheduled meeting to review available data once 1,500 enrolled infants had completed their 70-day follow-up period in order to assess the safety profile of Veronate and the trial's overall design parameters, the company said.

"Until the data is unblinded, these communications from the board are our only insight into the potential outcome of this trial, so we are very encouraged with its recommendation," said William D. Johnston, Inhibitex president and chief executive officer, in a company news release.

"While we cannot predict the ultimate result of this ongoing trial, the [board's] decision further reinforces our confidence regarding our assumed rate of infection, the adequacy of the statistical design and the powering of the trial relative to its primary endpoint. We continue to expect that top line results from the trial will be available in the second quarter of 2006."

The trial's primary endpoint is to demonstrate efficacy in the prevention of hospital-associated infections in premature, very low birth-weight infants due to staphylococcus aureus. Secondary endpoints include a reduction in the frequency of hospital-associated infections due to candida species and coagulase-negative staphylococci and a reduction in the mortality rate.

Veronate, an antibody-based investigational drug, is Inhibitex's most advanced product candidate and has been granted fast track designation and orphan drug status in the United States and has been recommended for orphan medicinal product designation in Europe, the company said.

Inhibitex, headquartered in Alpharetta, Ga., is a biopharmaceutical company that develops antibody-based products for the prevention and treatment of serious, life-threatening infections.

© 2015 Prospect News.
All content on this website is protected by copyright law in the U.S. and elsewhere. For the use of the person downloading only.
Redistribution and copying are prohibited by law without written permission in advance from Prospect News.
Redistribution or copying includes e-mailing, printing multiple copies or any other form of reproduction.