AiCuris: No Resistant Herpes Simplex Virus (HSV) Observed in Phase II Trial with Herpes Drug AIC316
Published: Sep 06, 2011
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.
"The fact that no potentially resistance mediating mutations were detected under AIC316 treatment is very encouraging" says Professor Helga Ruebsamen-Schaeff, CEO of AiCuris, "As we saw a clear dose-response within our trial, this result also means that even under a suboptimal therapy at the lower dose, which allowed some viral growth, no resistant mutants escaped."
Herpes simplex viruses (HSV) 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 newborns infected with HSV are at risk of developing a very dangerous herpes encephalitis. Unlike most of the current herpes drugs, which inhibit a specific viral enzyme, the DNA polymerase, AIC316 acts by a unique mechanism of viral inhibition. Currently available therapies share the same mode of action and are therefore similar in their efficacy, whilst in addition exhibiting possible cross-resistance. Based on its unique mode of action AIC316 not only is highly potent but it also is active against viruses, which have become resistant to existing drugs.
AiCuris GmbH & Co KG, a spin-out from Bayer HealthCare, is a privately held company located in Wuppertal, Germany . It is devoted to research and clinical development of novel, resistance-breaking drugs for the treatment of HCMV, Herpes, Hepatitis B, HIV and Hepatitis C as well as resistant Gram positive and Gram negative bacterial infections in hospitals. Furthermore, the portfolio comprises two immune modulators. One of these projects addresses auto-immune diseases, the other Hepatitis C.
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