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New drug may offer potent antiviral activity against human cytomegalovirus
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Promising preliminary data for AIC246, a novel treatment for human cytomegalovirus, were reported by Holger Zimmermann, MD, of AiCuris GmbH & Co.KG, at the 49th Annual Interscience Conference on Antimicrobial Agents and Chemotherapy.
Several researchers in Germany evaluated the anti-cytomegalovirus of AIC246 in vitro using laboratory strains and clinical isolates, including drug-resistant virus.
Phase 1 trials of the drug were conducted in more than 200 healthy participants, and a phase 2a trial involved 27 transplant recipients who participated in a 14-day pre-emptive treatment strategy. The researchers used DNA polymerase chain reaction as a biomarker for human cytomegalovirus.
The study drug demonstrated significant inhibitory activity against cytomegalovirus, including strains that were resistant to ganciclovir. The study drug also was well-tolerated.
Phase 2 trial results demonstrated that the reduction in viral markers was similar across all treatment groups.
“We administered twice-daily and once-daily doses,” Zimmerman said. “Regarding pharmacokinetic activity, there was no difference between the twice daily and once daily does, so this will make us move forward with the once-daily dose.”
DNA polymerase chain reaction in a transplant patient who had developed a multi-drug resistant strain of cytomegalovirus to the point of detection was reduced by AIC246, according to the results.
Zimmermann H. #V-1256b. Presented at: the 49th Annual Interscience Conference on Antimicrobial Agents and Chemotherapy; San Francisco; Sept. 11-15, 2009.