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news.Tobira Therapeutics, a clinical stage biotechnology company, has initiated a proof-of-concept study for TAK-652, a CCR5 antagonist, in HIV-infected, antiretroviral therapy-experienced, CCR5-naive patients. The study is being conducted under an investigational new drug application filed with the FDA.
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This Phase IIa randomized, double-blind, placebo-controlled study will evaluate the antiviral activity, safety and pharmacokinetics of TAK-652 by enrolling 40 therapy-experienced, CCR5-naive HIV-1-infected patients into one of four escalating dose groups ranging from 25mg to 100 once daily, administered for 10 days.
Each dose group of the study will enroll 10 patients, eight receiving TAK-652 and two receiving placebo. Approximately 13 sites in Argentina and the US will conduct this clinical trial.
James Sapirstein, CEO of Tobira, said: “Initiating the proof-of-concept study for TAK-652 is an important step for Tobira Therapeutics and we are very pleased with this progress. Our commitment to the development of new medicines for infectious diseases, and HIV in particular, remain a focus for Tobira Therapeutics.”