Tobira Reports Phase I Pharmacokinetic Data For TBR-652

Tobira Therapeutics (Tobira) has reported pharmacokinetic data and results from a double-blind, placebo-controlled, multiple-dose randomised study of TBR-652 in sixty healthy volunteers.

TBR-652, a CCR5 antagonist under investigation for the treatment of HIV, was evaluated at doses ranging from 25mg once daily (QD) to 200mg QD after a high fat meal.

Reportedly, pharmacokinetic parameters were measured on Days 1 and 10, while safety and tolerability were evaluated throughout the 10 day study. The results of the study demonstrate TBR-652 was well tolerated in all groups.

The company said that TBR-652 reached maximum plasma exposure 3-6 hours post dose on Days 1 and 10. Mean plasma half-life ranged from 40 to 45 hours, supporting once daily dosing. Exposure pharmacokinetic measures were greater than the therapeutic level projected from in vitro studies of TBR-652.

James Sapirstein, CEO at Tobira, said: “This phase I study provides further clinical support for the continued development of TBR-652 in the treatment of HIV. We are very encouraged by the excellent exposure results from the study and look forward to results from ongoing trials.”