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| | New Data on Tibotec Pharmaceuticals Ltd. HIV AIDS Investigational Product Portfolio |
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date: Feb 17th 2006 14:11
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Data presented by Tibotec Pharmaceuticals Ltd. at the 13th Conference on Retroviruses and Opportunistic Infections (CROI) in Denver, CO, last week reinforced the breadth of its research and development portfolio in HIV AIDS.
Since CROI last year, further progress has been made in the development of its investigational antiretrovirals, TMC114, a protease inhibitor (PI), and TMC125, a non-nucleoside reverse transcriptase inhibitor (NNRTI). Both TMC114 and TMC125 are currently in phase 3 clinical trials. The TMC114 file was recently submitted to both the FDA and EMEA. Both submissions are based on the efficacy and safety results of the 24-week dose-finding phase of two randomized controlled studies, known as POWER 1 and POWER 2, and supportive data from a non-randomized open label trial, POWER 3.
Tibotec Pharmaceuticals Ltd. research is focused on the identification and development of innovative compounds which may reduce viral loads to undetectable levels.
First results of TMC114 and TMC125 in Combination
The first clinical results of virologic response to TMC114 and TMC125 investigational compounds in combination were shown in a late-breaker poster at CROI (Boffito et al). In this pharmacokinetic (PK) study in HIV-1 infected patients (N=10) with substantial PI and NNRTI resistance, it was observed that eight out of the 10 patients achieved an undetectable viral load (<40 copies per ml HIV-RNA) by week 12 and all patient attained at least 2 log10 decrease in HIV-RNA at 12 weeks. In addition to TMC125 and TMC114 boosted with low-dose ritonavir, patients received two or more NRTIs two patients used enfuvirtide for the first time. No significant PK interaction was observed. These preliminary results are encouraging and suggest that the combination of these two investigational antiretrovirals may provide a new treatment option in heavily treatment-experienced patients such as these, said Marta Boffito, M.D., Ph.D., Chelsea and Westminster Hospital, London.
TMC125 is being studied in combination with TMC114 in the placebo-controlled phase 3 studies, DUET 1 and 2, which are currently enrolling in the U.S., Europe and other countries.
Understanding the factors predicting virologic response with TMC114
Following on from the primary results presented at IAS in July 2005 and ICAAC in December 2005, the results of resistance analyses of POWER 1, 2 and 3 showed that the TMC114 baseline fold change in EC50 (FC) was the strongest predictor of antiviral activity with TMC114 (De Meyer et al). A diminished TMC114 response was observed in the presence of multiple baseline PI-resistance-associated mutations (>10) together with one or more specific mutations nonetheless this response was still greater than that observed in the control groups in POWER 1 and 2. Conclusions regarding the relevance of particular mutations or mutational patterns are subject to additional data from long-term studies. Additionally the 24-week pharmacokinetic/pharmacodynamic analyses of the POWER 1 and 2 studies confirmed that baseline TMC114 FC rather than exposure influenced the virologic response to TMC114 (Sekar et al).
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