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Better Prevention of Transmission and Lesion Development of Genital Herpes Predicted for AiCuris Drug AIC316
Data showing stronger reduction of clinically relevant viral shedding in comparison with nucleosides to be presented at upcoming conferences
(PresseBox) (Wuppertal, Germany, )
AiCuris announced today that in depth analysis of data from the AIC316 Phase 2 trial in patients with genital herpes will be disclosed at several international meetings. This information adds to the very favourable efficacy data meeting the primary endpoint of the trial which have already been announced. It further highlights the superiority of AIC316 in the treatment of genital herpes.
The reduction of shedding of genital herpes simplex virus (HSV) by AIC316 in the recent Phase 2 trial will be compared with data from clinical trials with nucleoside analogues. AIC316, a HSV inhibitor with a novel mode of action and much improved half-life, shows superior reduction of shedding events associated with high viral load, which is regarded as clinically relevant for HSV lesion development and transmission.
AiCuris project leader Dr. Alexander Birkmann will present the data at the International Conference on Antiviral Research (ICAR) meeting in Sapporo, Japan, on 19th April 2012. Furthermore, Professor Helga Rübsamen-Schaeff, CEO of AiCuris, will give an invited talk on AIC316 discussing this topic at the International Herpesvirus Workshop in Calgary, Canada, 4th-9th August 2012.
"Encouraged by this data the planning and preparation of the Phase 3 program is now underway with high priority" comments Dr. Marie Paule Richard, CMO of AiCuris.
About AIC316
AIC316 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). AIC316 is active against both labial and genital herpes virus strains.
Based on this new mode of action - and in contrast to nucleoside analogues - AIC316 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, AIC316 also retains full activity against viruses that are resistant to marketed drugs. The favorably long plasma half-life of AIC316 on the one hand protects cells for extended periods of time against infection by the virus, on the other hand it is 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).
About HSV
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 newborns infected with HSV are at risk of developing very dangerous, potentially life-threatening herpes encephalitis.
The reduction of shedding of genital herpes simplex virus (HSV) by AIC316 in the recent Phase 2 trial will be compared with data from clinical trials with nucleoside analogues. AIC316, a HSV inhibitor with a novel mode of action and much improved half-life, shows superior reduction of shedding events associated with high viral load, which is regarded as clinically relevant for HSV lesion development and transmission.
AiCuris project leader Dr. Alexander Birkmann will present the data at the International Conference on Antiviral Research (ICAR) meeting in Sapporo, Japan, on 19th April 2012. Furthermore, Professor Helga Rübsamen-Schaeff, CEO of AiCuris, will give an invited talk on AIC316 discussing this topic at the International Herpesvirus Workshop in Calgary, Canada, 4th-9th August 2012.
"Encouraged by this data the planning and preparation of the Phase 3 program is now underway with high priority" comments Dr. Marie Paule Richard, CMO of AiCuris.
About AIC316
AIC316 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). AIC316 is active against both labial and genital herpes virus strains.
Based on this new mode of action - and in contrast to nucleoside analogues - AIC316 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, AIC316 also retains full activity against viruses that are resistant to marketed drugs. The favorably long plasma half-life of AIC316 on the one hand protects cells for extended periods of time against infection by the virus, on the other hand it is 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).
About HSV
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 newborns infected with HSV are at risk of developing very dangerous, potentially life-threatening herpes encephalitis.
Über AiCuris GmbH & Co. KG
AiCuris GmbH & Co KG is a privately held biopharmaceutical company located in Wuppertal, Germany and specializes in infectious diseases. Its activities comprise research and clinical development of innovative and resistance-breaking drugs against HCMV, HSV, Hepatitis B, HIV and Hepatitis C as well as resistant Gram positive and Gram negative bacterial infections in hospitals. Furthermore, AiCuris' portfolio comprises two immune modulators.
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