Tobira Therapeutics Presents TBR-652 Phase II Trial Data

TBR-652 Phase II trial demonstrated that a 10-day course of once-daily TBR-652 monotherapy produced a median nadir decline from baseline in HIV viral load of up to 1.8 log10copies/ml.

The study revealed dose-dependent changes in concentrations of monocyte chemoattractant protein-1 (MCP-1), the primary ligand for the CCR2 chemokine receptor and a potent chemoattractant for monocytes and macrophages, which provides further evidence of TBR-652’s dual action on CCR5 and CCR2, suggesting a potential anti-inflammatory benefit of the compound.

David Martin, senior vice president of drug development and regulatory affairs at Tobira Therapeutics, has presented data from study 652-2-201, a double-blind, placebo-controlled, dose-escalation trial in which patients were randomised four-to-one to receive doses of TBR-652 of 25mg, 50mg, 75mg, 100mg, 150mg and placebo.

All patients were HIV treatment-experienced, though none had previously been treated with a CCR5 antagonist.

Dr Martin said: “This study of TBR-652 showed a dose-dependent effect on MCP-1 levels, an important biomarker for CCR2 activity. The anti-inflammatory benefits of this dual CCR5/CCR2 antagonist are expected to be further investigated in a series of Phase IIb sub-studies to evaluate the effects of TBR-652 on immunologic and inflammatory parameters, including cardiovascular and metabolic endpoints.

“Our dual CCR5/CCR2 investigational drug may provide a new strategy that would complement the well-established benefits of currently available virus-suppressing treatments for HIV.”