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Clinical Trials

Date: 2011-07-18

Type of information:

phase: 2

Announcement: results

Company: AiCuris (Germany)

Product: AIC316

Action mechanism:

Disease: genital herpes

Therapeutic area: Infectious diseases

Country: USA

Trial details: 156 HSV-2 positive participants (105 women and 51 men) were randomized between May 2010 and October 2010 at seven sites in the US . The goal of the trial was to compare the efficacy of four different doses of AIC316 (5, 25, and 75 mg once daily, or 400 mg once weekly) and placebo with respect to the suppression of HSV shedding. All participants received the study drug or placebo daily or weekly for 4 weeks.

Latest news: Phase II results for AiCuris\' novel non-nucleosidic herpes simplex virus (HSV) inhibitor AIC316 reveal safety and efficacy in persons with genital herpes. The data were presented at the 19th ISSTDR Meeting (International Society for Sexually Transmitted Diseases Research) in Quebec , Canada , by the coordinating investigator of the trial, Professor Anna Wald from the University of Washington and Fred Hutchinson Cancer Research Center in Seattle , USA.
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 400 mg once weekly and the 75 mg 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. These data confirm an excellent antiviral efficacy in humans, a clear dose response and an overall good safety profile.

Is general: Yes