Johnson and Johnson announces TMC278 phase IIb study results

Tibotec Pharmaceuticals, a Johnson & Johnson company, has announced the publication of the results of a phase IIb dose-finding study of investigational compound TMC278.

Presented at the Conference on Retroviruses and Opportunistic Infections, the compound was studied in antiretroviral (ARV)-naive patients with HIV. As a result of the 48-week study, a 75 mg dose of the drug has been selected for phase III clinical trials.

In the trial, once daily doses of 25 mg, 75 mg and 150 mg of TMC278 and efavirenz were administered to patients in conjunction with Combivir or Truvada, as selected by the investigator.

TMC278 is a next-generation non-nucleoside reverse transcriptase inhibitor (NNRTI) and is the second NNRTI in clinical development from Tibotec.

Dr Anton Pozniak, at Chelsea and Westminster Hospital, said: “The results from the phase IIb study, suggest that TMC278 may provide an important alternative in the treatment of ARV-naive patients.”

He added that the study of the compound would now be continued at phase III.

Last month, Tibotec Pharmaceuticals announced the first results of a study investigating a combination of its TMC114 and TMC125 investigational compounds.

The study investigated the use of the compounds on patients that have exhibited significant resistance to NNRTIs and protease inhibitors, with the company reporting “encouraging” preliminary results.