Tibotec's HIV drug TMC125 effective in Ph IIb trials

In a presentation to the recent Interscience Conference on Antimicrobial Agents and Chemotherapy, held in Washington DC, USA, Ireland-based Tibotec Pharmaceuticals, a subsidiary of Johnson & Johnson, reported the results with TMC125, a non-nucleoside reverse transcriptase inhibitor in HIV-1 patients with drug resistance.

TMC125 was assessed in a Phase IIb dose-ranging, randomized, partially-blinded examination in 199 HIV-1 patients with substantial treatment exposure. The mean change from baseline in viral load was -1.04, -1.18 and -0.19 log10 copies/ml in the 400mg, 800mg and active control groups, respectively. In these patients, the viral load reduction was significantly greater than in the active control group after 24-weeks, the firm noted. Commonly reported adverse events were diarrhea and rash, seen in 20% of TMC125-treated subjects.

Tibotec has recently began two Phase III randomized, placebo-controlled trials of TMC125, and added that it hoped to enroll around 600 patients in 18 countries.