DGAP-News: AiCuris Anti-infective Cures GmbH / Key word(s): Study/Study
results
AiCuris Topical Pritelivir, a Highly Active Inhibitor for the Treatment of
Herpes Simplex Virus, Achieves Primary Endpoint in Clinical Phase I Study
23.08.2016 / 09:30
The issuer is solely responsible for the content of this announcement.
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AiCuris Topical Pritelivir, a Highly Active Inhibitor for the Treatment of
Herpes Simplex Virus, Achieves Primary Endpoint in Clinical Phase I Study
Wuppertal, August 23rd, 2016 – AiCuris Anti-infective Cures GmbH, a leading
company in the discovery and development of drugs against infectious
diseases, today announced that pritelivir (one of its lead compounds), a
small molecule helicase-primase inhibitor active against herpes simplex
virus type 1 (HSV-1) and type 2 (HSV-2), achieved the primary endpoint in a
phase I trial for topical treatment of recurrent labial herpes (cold
sores). In this trial with healthy volunteers, pritelivir 5% ointment did
not show any cumulative irritation potential. This phase I trial is part of
a second development program for pritelivir, after it has already shown
superiority against standard treatment valacyclovir in a clinical phase II
trial in patients with genital HSV-2 infection with oral treatment.
The randomized, single-center, controlled, within-subject comparison phase
I trial (AIC316-02-I-01), conducted in the U.S., was designed to determine
the local cumulative irritation potential of topical pritelivir on normal
human skin in 46 male and female healthy volunteers under occlusive
conditions. Each volunteer received daily pritelivir 5% ointment and in
parallel three controls for 21 days on the back. The controls were: the
vehicle ointment without pritelivir, saline as a negative control and 0.2%
sodium lauryl sulfate (SLS) as a positive control. Application sites were
assessed daily in a blinded manner by evaluators for dermal reactions using
a visual skin irritation scoring system to rate the degree of erythema,
edema and other signs of skin irritation. The trial showed that pritelivir
5% ointment had no cumulative irritation potential; as expected, the
positive control SLS caused local irritation in all subjects.
“These phase I results, coupled with the preclinical results we have seen
with topical pritelivir, are highly promising and strongly support the
further development of topical pritelivir for recurrent labial herpes,”
said Dr. Holger Zimmermann, CEO of AiCuris Anti-infective Cures GmbH.
“There remains a major unmet medical need to treat HSV-1 infections, such
as labial herpes, as there are very few specific antivirals available and
available topical treatments are often ineffective. Topical pritelivir, if
proven safe and effective in further clinical testing, could be an
important new treatment option for this very painful condition. We are
looking forward to continued progress with this innovative approach and
expect to start a clinical phase II proof of concept study in the U.S.
later this year.”
About Pritelivir
Pritelivir is an innovative, highly active and specific inhibitor of herpes
simplex virus (HSV). Derived from a novel chemical class (thiazolylamides),
pritelivir is active against both types of herpes simplex virus (HSV-1 and
HSV-2), 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 treating HSV infections (i.e., the nucleoside
analogues acyclovir and its prodrug valacyclovir as well as famciclovir,
the prodrug of penciclovir). While 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 is therefore also protective to
uninfected cells.
Currently the company runs two clinical development programs with
pritelivir. The most advanced program, pritelivir (oral), showed
superiority against standard treatment valacyclovir in a clinical phase II
trial in patients with genital HSV-2 infection. Pritelivir (topical),
designed for the treatment of recurrent labial herpes (mainly HSV-1), has
reported successful phase I clinical results.
About HSV
Herpes simplex viruses (HSV) are widespread (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. The
negative stigma associated with genital herpes and visible facial lesions
may 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. The
company’s majority investor is SANTO Holding. The company is developing
drugs for the treatment of viruses such as human cytomegalovirus (HCMV),
herpes simplex virus (HSV), hepatitis B virus (HBV), and adenoviruses. In
the field of antibacterials, AiCuris seeks to develop innovative treatment
options for life-threatening, multi-resistant hospital-treated pathogens.
In 2012, AiCuris signed a license agreement with Merck & Co (MSD), one of
the largest agreements of its kind in the European biotech industry. The
agreement covers the development of novel drug candidates against HCMV.
Letermovir, the most advanced compound under this agreement, is currently
in phase III clinical trials in patients undergoing bone marrow
transplantation.
Contact:
Media Relations
AiCuris Anti-infective Cures MC Services AG
GmbH
Katja Woestenhemke Anne Hennecke
Friedrich-Ebert-Str. 475/Geb. Kaiser-Friedrich-Ring 5
302
42117 Wuppertal 40545 Düsseldorf
Phone +49 202 317 63 0 Phone +49 211 529 252 22
Fax +49 202 317 63 1601 Fax +49 211 529 252 29
Email business@aicuris.com Email anne.hennecke@mc-services.eu
Web www.aicuris.com Web www.mc-services.eu
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23.08.2016 Dissemination of a Corporate News, transmitted by DGAP – a
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