FDAnews
www.fdanews.com/articles/86724-incyte-begins-study-of-new-hiv-drug

INCYTE BEGINS STUDY OF NEW HIV DRUG

May 10, 2006

Incyte has initiated a Phase I clinical trial of INCB9471, a new orally available CCR5 antagonist that is being developed as a treatment for patients infected with human immunodeficiency virus (HIV-1). CCR5 antagonists are a new class of antiretroviral compounds that have been shown to block entry of the HIV virus into the cell, unlike nearly all of the existing HIV drugs that prevent viral replication within the cell.

The trial is a double-blind, placebo-controlled, single-rising-dose study designed to assess the safety and pharmacokinetics of INCB9471 in healthy volunteers. A Phase I multiple dose study, also in healthy volunteers, is expected to begin in July. A Phase IIa trial involving HIV patients is scheduled to initiate later this year.