WUPPERTAL, Germany I April 4, 2016 I AiCuris Anti-infective Cures GmbH, a leading company in the discovery and development of drugs against infectious diseases, today announced the start of a new clinical program using a topical formulation of pritelivir, a small molecule helicase-primase inhibitor active against herpes simplex virus type 1 (HSV-1) and type 2 (HSV-2). An ongoing phase 1 trial in the U.S. has recruited 46 volunteers who are being treated for 21 consecutive days with topical pritelivir.
The trial is designed to determine the cumulative irritation potential of topical pritelivir on normal human skin in healthy volunteers under occlusive conditions. Topical pritelivir will be delivered via a patch placed on the volunteer. Each volunteer will also receive three controls: the vehicle ointment without the drug, a positive control, a product expected to be mildly irritating, and a negative control product that should not be irritating at all. The primary end point of the trial is safety, also measured using a dermatological evaluation based on a skin irritation scoring system.
“The prevalence for HSV-1 infections is estimated to be in the range of 40% – 60% in developed countries and even up to 80% in low socioeconomic status countries. There are only few specific antivirals available and standard treatments are often not very effective, especially when administered topically. Very promising results from preclinical studies with topical pritelivir and the excellent phase 2 results with oral pritelivir in genital HSV infections showing superior efficacy over the gold standard valacyclovir encourages us to further exploit the potential of pritelivir for the topical treatment of recurrent labial herpes” said Dr. Holger Zimmermann, CEO of AiCuris Anti-infective Cures GmbH. “The pritelivir program with oral and topical treatment options will potentially open a whole HSV market to AiCuris and will help to address significant unmet medical needs.”
About Pritelivir
Pritelivir is an innovative, highly active and specific inhibitor of herpes simplex virus (HSV). As a compound derived from a novel chemical class (thiazolylamides), pritelivir is active against both types of herpes simplex virus causing labial and genital herpes, respectively, and retains activity against viruses which have become resistant to marketed drugs. Pritelivir has a mode of action that is distinct from other antiviral agents currently in use for treatment of HSV infections (i.e., the nucleoside analogues acyclovir and its prodrug valacyclovir as well as famciclovir, the prodrug of penciclovir). Whereas nucleoside analogs terminate ongoing DNA chain elongation through inhibition of viral DNA polymerase, pritelivir prevents de novo synthesis of virus DNA through inhibition of the helicase-primase complex. In addition, it does not require activation within an HSV infected cell by viral thymidine kinase and therefore, is also protective to uninfected cells.
Currently the Company runs two clinical development programs with pritelivir. The most advanced, pritelivir (oral), showed superiority against standard treatment valacyclovir in a clinical phase 2 trial. Pritelivir (topical), designed for the treatment of recurrent labial herpes (mainly HSV-1), just entered into phase 1 clinical testing.
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). Infections lead to lifelong persistence of the virus, with frequent and sometimes painful recurrences. While HSV-1 predominantly causes oral lesions (cold sores), HSV-2 manifests in the genital region and is mainly sexually transmitted. In immunocompromised patients, HSV can lead to serious complications. In the immune competent, the negative stigma associated with genital herpes and visible facial lesions might cause psychological distress.
According to the WHO an estimated 3.7 billion people worldwide under the age of 50, or 67% of the population, were infected with HSV-1 in 2012. Prevalence of the infection was estimated highest in Africa (87%) and lowest in the Americas (40-50%).
About AiCuris Anti-infective Cures GmbH:
AiCuris was founded in 2006 as a spin-off from Bayer and focuses on the discovery and development of drugs against infectious diseases. Majority investor is the family office of the Dres. Strüngmann. The company is generating drugs against viruses such as human cytomegalovirus (HCMV), herpes simplex virus and hepatitis B virus (HBV). With respect to bacteria, AiCuris is concentrating on the search for innovative treatment options against life-threatening (multi)resistant nosocomial pathogens. In 2012 AiCuris signed a license agreement with Merck & Co (MSD), which attracted significant attention being one of the largest agreements of this kind in the European biotech industry. The agreement covers the development of novel drug candidates against HCMV. Letermovir, the most advanced compound, is currently in phase 3 clinical trials in patients undergoing bone marrow transplantation.
SOURCE: AiCuris
Post Views: 164
WUPPERTAL, Germany I April 4, 2016 I AiCuris Anti-infective Cures GmbH, a leading company in the discovery and development of drugs against infectious diseases, today announced the start of a new clinical program using a topical formulation of pritelivir, a small molecule helicase-primase inhibitor active against herpes simplex virus type 1 (HSV-1) and type 2 (HSV-2). An ongoing phase 1 trial in the U.S. has recruited 46 volunteers who are being treated for 21 consecutive days with topical pritelivir.
The trial is designed to determine the cumulative irritation potential of topical pritelivir on normal human skin in healthy volunteers under occlusive conditions. Topical pritelivir will be delivered via a patch placed on the volunteer. Each volunteer will also receive three controls: the vehicle ointment without the drug, a positive control, a product expected to be mildly irritating, and a negative control product that should not be irritating at all. The primary end point of the trial is safety, also measured using a dermatological evaluation based on a skin irritation scoring system.
“The prevalence for HSV-1 infections is estimated to be in the range of 40% – 60% in developed countries and even up to 80% in low socioeconomic status countries. There are only few specific antivirals available and standard treatments are often not very effective, especially when administered topically. Very promising results from preclinical studies with topical pritelivir and the excellent phase 2 results with oral pritelivir in genital HSV infections showing superior efficacy over the gold standard valacyclovir encourages us to further exploit the potential of pritelivir for the topical treatment of recurrent labial herpes” said Dr. Holger Zimmermann, CEO of AiCuris Anti-infective Cures GmbH. “The pritelivir program with oral and topical treatment options will potentially open a whole HSV market to AiCuris and will help to address significant unmet medical needs.”
About Pritelivir
Pritelivir is an innovative, highly active and specific inhibitor of herpes simplex virus (HSV). As a compound derived from a novel chemical class (thiazolylamides), pritelivir is active against both types of herpes simplex virus causing labial and genital herpes, respectively, and retains activity against viruses which have become resistant to marketed drugs. Pritelivir has a mode of action that is distinct from other antiviral agents currently in use for treatment of HSV infections (i.e., the nucleoside analogues acyclovir and its prodrug valacyclovir as well as famciclovir, the prodrug of penciclovir). Whereas nucleoside analogs terminate ongoing DNA chain elongation through inhibition of viral DNA polymerase, pritelivir prevents de novo synthesis of virus DNA through inhibition of the helicase-primase complex. In addition, it does not require activation within an HSV infected cell by viral thymidine kinase and therefore, is also protective to uninfected cells.
Currently the Company runs two clinical development programs with pritelivir. The most advanced, pritelivir (oral), showed superiority against standard treatment valacyclovir in a clinical phase 2 trial. Pritelivir (topical), designed for the treatment of recurrent labial herpes (mainly HSV-1), just entered into phase 1 clinical testing.
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). Infections lead to lifelong persistence of the virus, with frequent and sometimes painful recurrences. While HSV-1 predominantly causes oral lesions (cold sores), HSV-2 manifests in the genital region and is mainly sexually transmitted. In immunocompromised patients, HSV can lead to serious complications. In the immune competent, the negative stigma associated with genital herpes and visible facial lesions might cause psychological distress.
According to the WHO an estimated 3.7 billion people worldwide under the age of 50, or 67% of the population, were infected with HSV-1 in 2012. Prevalence of the infection was estimated highest in Africa (87%) and lowest in the Americas (40-50%).
About AiCuris Anti-infective Cures GmbH:
AiCuris was founded in 2006 as a spin-off from Bayer and focuses on the discovery and development of drugs against infectious diseases. Majority investor is the family office of the Dres. Strüngmann. The company is generating drugs against viruses such as human cytomegalovirus (HCMV), herpes simplex virus and hepatitis B virus (HBV). With respect to bacteria, AiCuris is concentrating on the search for innovative treatment options against life-threatening (multi)resistant nosocomial pathogens. In 2012 AiCuris signed a license agreement with Merck & Co (MSD), which attracted significant attention being one of the largest agreements of this kind in the European biotech industry. The agreement covers the development of novel drug candidates against HCMV. Letermovir, the most advanced compound, is currently in phase 3 clinical trials in patients undergoing bone marrow transplantation.
SOURCE: AiCuris
Post Views: 164
