The outcomes were concluded after the release of phase III clinical trial data. Apricitabine (ATC) is an anti-HIV nucleoside reverse transcriptase inhibitor (NRTI). The company had completed the 96 week dosing for the phase IIb trials in 2008, which demonstrated that after dosing, patients with HIV levels below detectable was over 90%. The phase III trail was initiated in January 2008, in patients with NRTI resistance.
The results showed that patient have reached undetectable viral loads on ATC, however the result was not statistically significant as the trail was dropped early than estimated. It also enrolled fewer number of patient than projected. Avexa will continue to proceed the trial and expects to come-up with detailed results by the end of first quarter of 2010.
The study compared ATC to 3TC in HIV patients with drug-resistance. The patients were administered 800mg of ATC, twice daily. During the study, 53% patients showed undetectable viral load levels against the 51% of patients who showed undetectable viral load in the placebo.
Jonathan Coates, chief scientific officer of Avexa, said that the study highlighted the ability of ATC to maintain suppression of patients' viral loads, while increasing CD4+ cell numbers. He also said that the drug could be a significant addition to new class of HIV drug.
Julian Chick, chief executive officer of Avexa, expects that the phase III data will help improve clinical outcomes for patients suffering from HIV.