Avexa: Viral load ‘undetectable’
Nick Evans
Thursday, 13 March 2008
AVEXA has returned more excellent results from the company’s much anticipated 48-week data on the Phase 2 trial of HIV drug apricitabine (ATC). The company said that more than 90% of the patients taking the drug had undetectable levels of the virus at the 48-week stage, and patients who switched to ATC from existing treatment 3TC also showed measurable improvement.
The study has also continued to show that the patients' own immune systems recovered strongly due to the treatments. CD4 – also called "helper T-cells" – counts of patients taking the drug improved substantially over the trial, including those patients who switched from 3TC to ATC at the 24-week point.
Dr Ben McCaw from eG Capital said the summary results were a very positive sign for the company.
He said the 48-week results would help alleviate some of the uncertainty over the long-term safety and efficacy of the drug.
“Notably, the tolerability profile of ATC showed no signs of deterioration between weeks 24 and 48 (a key risk that we highlighted earlier), and there were no reported signs of emergence of viral resistance to ATC,” he said.
“Although summary in nature, the 48-week data set further reinforces our view that ATC is positioned well with respect to 3TC from an efficacy perspective, and goes some way to alleviating uncertainty concerning longer-term safety and viral resistance issues.
“Additionally, we view the data as further aiding the prospect of Avexa striking a collaborative deal with a larger pharmaceutical player, something we are confident that management is working hard to achieve.”
McCaw said it was a good sign that the shift from 3TC to ATC also accelerated the increase in patient CD4 cell counts, and that CD4 counts of patients in the original 800mg ATC arm continued to increase, although at a lower rate than observed between 24 and 48 weeks, as expected.
“Moreover, we are encouraged by decrease in viral loads reported for patients with three or more thymidine analogue mutations (TAMs), as this group typically fares poorly when managed with prevailing therapy algorithms,” he said.
Avexa chief executive Dr Julian Chick said the results demonstrated the benefits of the drug as a treatment.
“These exciting results indicate that the clinical and immunological benefit of ATC continues to increase with long-term treatment out to 48 weeks,” he said.
“This is compelling evidence of the improvements that can be obtained when patients switch to ATC from 3TC.
“These 48-week results clearly define ATC as a drug with huge potential both for drug-resistant patients in need of potent and safe new HIV therapies and for patients whose regimen currently contains 3TC.”
The announcement failed to shift Avexa shares much, with the company’s stock rising only 1c to 44c on the news.
The gain appears to have been already built into the company’s current price, however, with Avexa shares making substantial gains in recent weeks as traders speculated on the outcome of the data.
Avexa shares began March trading at 36c, and rose as high as 49.5c last Friday, before dropping back to the current levels.
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