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news.US-based biopharmaceutical company Idenix Pharmaceuticals has completed the proof-of-concept study evaluating IDX899, a non-nucleoside reverse transcriptase inhibitor being developed for the treatment of HIV-1.
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Data from the study demonstrate that the 100mg/day cohort achieved a mean plasma viral load reduction of 1.87 log10 after seven days of treatment, similar to the potency observed with the other evaluated doses of 800mg, 400mg and 200mg/day in this study. As with the other cohorts, no treatment-related serious adverse events were reported for any of the patients receiving 100mg/day of IDX899 and no patients discontinued the study.
The Phase I/II clinical trial was designed to evaluate the safety, tolerability, antiviral activity and pharmacokinetics of IDX899. Four cohorts of 800mg/day, 400mg/day, 200mg/day and 100mg/day were completed with 10 HIV-1-infected treatment-naive patients randomized 8:2 in each cohort to receive oral once-daily IDX899 or matching placebo, respectively, for seven days.
Patients (n=32) receiving once-daily oral administration of 800mg, 400mg, 200mg and 100mg of IDX899 achieved mean viral load reductions of 1.78, 1.78, 1.84 and 1.87 log10, respectively, after seven days of treatment as tested with the Roche Amplicor 1.5 assay. Patients (n=8) receiving placebo achieved a mean plasma viral load increase of 0.10 log10.
Two additional studies were also completed that evaluated the potential for a pharmacokinetic drug-drug interaction between IDX899 and other drugs for the treatment of HIV-1, as well as the safety and tolerability of IDX899 when administered in combination with those drugs. These separate studies were conducted using Reyataz and Truvada in combination with IDX899 and concluded that the study drugs were well tolerated and there were no clinically relevant drug-drug interactions.
Douglas Mayers, Idenix’s chief medical officer, said: “We are pleased that HIV-1-infected patients receiving IDX899 in this trial achieved potent viral suppression at all doses tested. With the promising antiviral activity and safety profile seen to date, especially at low doses, we believe that IDX899 could become an important part of combination antiretroviral therapy.”