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news.Incyte Corporation has initiated a phase I clinical trial of its HIV drug candidate INCB9471, an orally available CCR5 antagonist.
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CCR5 antagonists are a new class of antiretroviral compound 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.
Because these compounds act through a different mechanism, they are active against strains of the virus that are resistant to currently used HIV treatments.
The phase I trial is a placebo-controlled, single rising dose study designed to assess the safety and pharmacokinetics of the drug in healthy volunteers. A phase I multiple dose study, also in healthy volunteers, is expected to begin in July, and a phase IIa trial involving HIV patients is scheduled to begin later this year.
In preclinical studies the drug has shown potent anti-viral activity as well as excellent pharmacokinetic properties that are consistent with convenient once-daily dosing as part of a HAART regimen.