Wuppertal, 29th January 2013 - AiCuris announced today 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, www.clinicaltrials.gov) 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.
Pritelivir is a potent inhibitor of HSV replication. It has a new mode of action (inhibition of the viral helicase-primase enzyme complex) and a favorably long plasma half-life. In a previous trial pritelivir treatment led to a highly significant and dose dependent reduction of viral shedding, the amount of virus shed, and of clinical lesions.
“It is encouraging to see that recruitment is going so well, despite the ongoing commitment required from participants in this trial, including numerous visits to the trial site and other activities which have to be fitted into the daily routine” commented Dr. Burkhard Timmler, Medical Director at AiCuris.
“This high motivation of patients appears to indicate their dissatisfaction with present therapies. We are looking forward to the opportunity to demonstrate the superior efficacy of pritelivir and to change the therapeutic options for patients suffering from herpes” added AiCuris´ CEO Prof. Helga Rübsamen-Schaeff.
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About pritelivir (AIC316)
Pritelivir is an innovative, highly active and 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). Pritelivir is active against both labial and genital herpes virus strains.
Based on this new mode of action – and in contrast to nucleoside analogues - pritelivir does not require activation by viral thymidine kinase in an infected cell and therefore, is active in – and protective for –uninfected cells. Similarly, due to its different mode of action, pritelivir also retains full activity against viruses that are resistant to marketed drugs. The favorably long plasma half-life of pritelivir on the one hand protects cells for extended periods of time against infection by the virus, on the other hand it offers very convenient dosing regimens for patients (expected: one pill per episode for treatment of a herpes episode, once weekly treatment for suppression of genital herpes).
Herpes simplex viruses are widespread in the human population (seroprevalence up to 100%, depending on geographic area and subpopulation), and are divided into herpes simplex virus type 1 (HSV-1) and type 2 (HSV-2). While HSV-1 predominantly causes oral lesions (cold sores), HSV-2 manifests in the genital region and is mainly transmitted sexually. However, the past decade has seen an increase in HSV-1 genital infections, which now account for at least half of first episodes of genital herpes in some countries. Both labial and genital herpes are generally self-limiting but can recur frequently. HSV infections have also been associated with a three-fold increase in the risk of sexually acquired HIV. In immune compromised individuals large and painful ulcerations may result, and new-borns infected with HSV are at risk of developing very dangerous, potentially life-threatening herpes encephalitis.
AiCuris GmbH & Co KG is a privately held biopharmaceutical company located in Wuppertal, Germany and specializes in research and clinical development of drugs against infectious diseases. Its portfolio comprises innovative and resistance-breaking drugs against the Human Cytomegalovirus (HCMV, licensed to Merck & Co), Herpes Simplex Virus (HSV), Human Immunodeficiency Virus (HIV) as well as against resistant Gram positive and Gram negative bacterial infections in hospitals. Furthermore, two immune modulators complement AiCuris´ portfolio. One of these is directed against viral hepatitis (hepatitis B and C) and fibrosis, the other against autoimmune diseases.