AiCuris announced today that the last subject has completed their Phase-II trial "A double-blind randomized placebo controlled dose-finding trial to investigate different doses of a new antiviral drug in subjects with genital HSV Type 2 infection".
The trial has been completed two months earlier than planned. Indeed, in the later stages of the trial, enrolment had to be restricted as the number of subjects was higher than the number that was required to be enrolled according to the trial protocol. "We were surprised by the interest in our trial and the number of requests for participation that we received from people infected with herpes simplex virus" said Dr. Burkhard Timmler, Associate Director Clinical Development at AiCuris. "In spite of available therapeutic options there seems to be a great demand for a new, well tolerated and efficacious drug for people suffering from genital herpes".
AiCuris plans to have the first data available in early 2011. "We hope that the results will allow us to determine the efficacious dose of AIC316 and confirm the potential for once daily oral dosing in genital herpes. Our ultimate goal is to address the still existing unmet medical need in the field of genital herpes infections with this drug which acts by a unique mode of action", adds Prof. Rübsamen-Schaeff, CEO of AiCuris.
About Herpes
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 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.
The trial has been completed two months earlier than planned. Indeed, in the later stages of the trial, enrolment had to be restricted as the number of subjects was higher than the number that was required to be enrolled according to the trial protocol. "We were surprised by the interest in our trial and the number of requests for participation that we received from people infected with herpes simplex virus" said Dr. Burkhard Timmler, Associate Director Clinical Development at AiCuris. "In spite of available therapeutic options there seems to be a great demand for a new, well tolerated and efficacious drug for people suffering from genital herpes".
AiCuris plans to have the first data available in early 2011. "We hope that the results will allow us to determine the efficacious dose of AIC316 and confirm the potential for once daily oral dosing in genital herpes. Our ultimate goal is to address the still existing unmet medical need in the field of genital herpes infections with this drug which acts by a unique mode of action", adds Prof. Rübsamen-Schaeff, CEO of AiCuris.
About Herpes
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 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.
