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news.An independent data safety monitoring board reviewing Inhibitex's pivotal phase III clinical trial of Veronate, a treatment for the prevention of hospital-associated infections in premature infants, has recommended that the trial should be completed without modification.
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The data safety monitoring board (DSMB) made its recommendation in a meeting with the company, the purpose of which was 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.
“While we cannot predict the ultimate result of this ongoing trial, the DSMB 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,” Dr William Johnston, president and CEO of Inhibitex. “We continue to expect that top line results from the trial will be available in the second quarter of 2006.”