Date: 2013-01-29
Type of information:
phase: 2
Announcement: 50% patient enrollment
Company: Aicuris (Germany)
Product: pritelivir (AIC316)
Action
mechanism: Pritelivir is an specific inhibitor of herpes simplex virus (HSV) addressing a novel target (the viral helicase-primase complex). It also stems from a novel chemical class (thiazolylamides). It is active against both labial and genital herpes virus strains.
Based on this new mode of action, pritelivir does not require activation by viral thymidine kinase and therefore, is active – and protective – in uninfected cells. Similarly, due to its different mode of action, it also retains full activity against viruses that are resistant to marketed drugs.
Disease: genital herpes
Therapeutic area: Infectious diseases
Country: USA
Trial details:
Latest
news: * On January 29, 2013, AiCuris has announced that it has achieved over 50% patient enrollment in the second clinical efficacy trial with its novel anti-herpes simplex virus (HSV) drug pritelivir (formerly known as AIC316). Trial AIC316-01-II-02 (NCT01658826, compares the potency of pritelivir in reducing genital HSV shedding with valacyclovir.
The 53 enrolled subjects (over 50% of the required cohort of 90) have been randomized and have started the first 28 day treatment period. In two consecutive treatment periods, both for 28 days, each participant will receive a blinded daily dose of either pritelivir or valacyclovir before switching to the other treatment (so-called crossover design). The primary endpoint is the proportion of genital swabs positive for HSV during each treatment period. Further endpoints are the amount of viral DNA in these swabs, the number of days with genital lesions and duration of pain.
* On November 27, 2012, AiCuris has announced that it has started the second clinical efficacy trial with pritelivir (AIC316), its novel anti-herpes simplex virus (HSV) drug in development. After the first trial showed a high efficacy of pritelivir against genital herpes, the present trial AIC316-01-II-02 (NCT01658826) is designed to prove superiority of pritelivir vs. valacyclovir in reducing genital HSV shedding.
