Panacos’s Phase IIb bevirimat data support further dose escalation study

In this cohort, nine patients received 350mg of bevirimat solution once daily and two patients received placebo for 14 days on top of their failing background regimen. The presented data support further dose escalation in the study.

A mean viral load reduction of 0.62 log10 was seen in the nine bevirimat-treated patients on day 15, the primary endpoint of the study. Of these patients, three (33%) had greater than a 0.5 log10 reduction, all of which also had greater than a 1 log10 reduction. This compared to five of a total of eight patients with greater than a 1 log10 reduction in the 300mg cohort of the trial. Bevirimat continued to be well tolerated in this cohort, consistent with previous clinical experience. All adverse events were mild and there were no clinically relevant lab abnormalities.

Pending full analysis and FDA review of the data, the company intends to initiate a 400mg cohort in order to ensure it has fully explored the dose/response relationship.

Alan Dunton, Panacos’s CEO, said: “Based on a preliminary analysis of these and the other cohorts in this study, we believe there is a population of HIV patients that responds very well to bevirimat, with viral load change of greater than 1 log10. There is another population that does not respond as well at current dose levels. We plan to explore this further in the 400mg dose cohort. We believe we may be at, or close to, the peak of the dose response curve in the population of patients who respond very well and believe that we are on track to move expeditiously into pivotal studies in this group in 2008.”