Date: 2011-09-06
Type of information:
phase: 2
Announcement: results
Company: AiCuris (Germany)
Product: AIC316
Action mechanism:
Disease: genital herpes
Therapeutic area: Infectious diseases
Country:
Trial details: In the trial 156 HSV-2 positive subjects were randomized to either one of four AIC316 treatment groups or to placebo. Objective of the trial was to compare the efficacy of different doses of AIC316 (5, 25, and 75 mg once daily and 400 mg once weekly) and placebo with respect to the suppression of HSV mucocutaneous shedding under treatment. Trial participants provided daily swabs of their genital area that were analyzed for HSV DNA.
Latest
news: Aicuris has announced the results of the resistance analysis from the recently completed phase II clinical trial with AIC316. The compound was tested in patients with genital herpes (herpes simplex virus type 2, HSV-2). Treatment with AIC316 was safe and well tolerated. A significant and dose dependent reduction of both viral DNA and days with HSV lesions could be demonstrated.
Positive swabs were subjected to DNA sequence analysis and sequence data of relevant regions in the viral UL5 helicase and UL52 primase genes (the molecular targets of AIC316) were compared with the HSV-2 reference sequence. It could be shown that under treatment with AIC316 in this phase II trial there was no emergence of viruses with any of the recognized resistance mutations.
These results have been presented at the 51st Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC) in USA, Chicago, 17 - 20 September, 2011 (Session 112, 18th September 2011 at 11:15 am, Presentation V-941b)..
