Early phase trial results progress GSK's investigational CCR5 antagonist to next phase
Results from an early phase clinical trial evaluating a new class of AIDS therapy under development by GlaxoSmithKline (GSK) in healthy volunteers were presented at the 11th Conference on Retroviruses and Opportunistic Infections (CROI). The therapy, known as a cellular chemokine receptor (CCR5) antagonist also demonstrated preliminary data for receptor binding that may support once-daily or twice-daily dosing. These data support moving the compound identified in the GSK pipeline as 873140, into studies in HIV-infected individuals. 873140 (ONO-4128) was licensed by Ono Pharmaceuticals to GSK for worldwide commercialization. The CCR5 receptor is believed to be the predominant co-receptor used by HIV to enter and infect vital immune cells, called CD4 cells. Blocking the CCR5 receptor with an antagonist may provide an alternative mechanism for inhibiting HIV infection of CD4 cells.
In the double blind, randomized, placebo-controlled, single- and multiple-dose escalation study of 70 subjects presented at CROI, no serious adverse events, grade 3 or 4 adverse events or incidences of QTc prolongation were reported.
"Of the HIV-infected individuals in the world who have received treatment, a large proportion has developed viral resistance to currently available medicines, making resistance a growing issue in the field of HIV that will need to be addressed," said Joseph Eron, Jr., associate professor of medicine, University of North Carolina Chapel Hill. "We recognize the need for new anti-HIV drugs in existing and new pharmacologic classes. Our aim is to meet this need with continued research and development of HIV therapies," said Ken Batchelor, senior vice president, Center of Excellence for Drug Discovery-Metabolic and Viral Diseases, GSK.
To achieve these goals, in addition to CCR5 receptors, GSK has active research programs on a variety of HIV targets including non-nucleoside reverse transcriptase inhibitors, integrase inhibitors, protease inhibitors and nucleoside reverse transcriptase inhibitors.