Phase II results for AiCuris' novel non-nucleosidic herpes simplex virus (HSV) inhibitor AIC316 reveal safety and efficacy in persons with genital herpes.
A total of 156 HSV-2 positive participants (105 women and 51 men) were randomized between May 2010 and October 2010 at seven sites in the U.S. The goal was to compare the efficacy of four different doses of AIC316 (5mg, 25mg, and 75mg once daily, or 400mg once weekly) and placebo with respect to the suppression of HSV shedding. All participants received the study drug or placebo daily or weekly for four weeks.
AIC316 was safe and well tolerated at all doses administered and led to a significant reduction of viral shedding in a dose dependent manner. The strongest treatment effect was seen in the 400mg once-weekly and the 75mg once-daily dosing groups. Moreover, AIC316 led to a significant reduction of the amount of HSV found. This highly suppressive effect of AIC316 on viral replication also correlated with a significant clinical benefit: the proportion of days with reported genital lesions was reduced from 13.7 % to 1.1 %; the number of recurrences was substantially reduced as well.