DGAP-News: AiCuris GmbH & Co. KG / Key word(s): Study results
AiCuris GmbH & Co. KG: AiCuris’ AIC649 Shows Potential to Induce Functional
Cure of Chronic Hepatitis B in Preclinical Study
05.01.2016 / 09:30
The issuer is solely responsible for the content of this announcement.
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AiCuris’ AIC649 Shows Potential to Induce Functional Cure of Chronic
Hepatitis B in Preclinical Study
– Twice weekly treatment with AIC649 showed antiviral effect similar to
twice daily treatment with Tenofovir in HBV transgenic mice
– Bi-phasic treatment response in woodchuck chronic hepatitis B model
– Data published in peer-reviewed article in PLOS ONE
Wuppertal, January 5th, 2016 – AiCuris Anti-infective Cures GmbH, a leading
company in the discovery and development of drugs against infectious
diseases, today announced the publication of results from a preclinical
study assessing the antiviral efficacy of the Company’s proprietary immune
modulator AIC649 as well as its potential to induce functional cure in
animal models for chronic hepatitis B. The peer-reviewed article titled
“AIC649 Induces a Bi-Phasic Treatment Response in the Woodchuck Model of
Chronic Hepatitis B” was published on December 14, 2015 online on PLOS ONE
(www.plosone.org).
AIC649 is an inactivated parapoxvirus ovis (iPPVO) particle preparation
with distinct immunological activities including regulated cytokine release
and activation of T-cell responses. Currently, AIC649 is investigated in a
clinical phase I study in patients with chronic hepatitis B.
To analyze the antiviral efficacy, hepatitis B transgenic mice were treated
either twice-weekly with AIC649 or twice daily with “gold standard”
Tenofovir or vehicle over a period of 29 days. Both treatment regimens
showed a significant reduction of hepatitis B virus (HBV) titer compared to
the control group. Noteworthy, the twice-weekly treatment with AIC649
showed an antiviral effect similar to the twice-daily treatment with
Tenofovir.
The potential to induce functional cure of hepatitis B was studied in
chronically woodchuck hepatitis virus (WHV) infected woodchucks. Animals
were treated twice-weekly with AIC649 or vehicle over an eight-week period
followed by an additional 16-week observation period. Hepatitis surface
antigen (WHsAg) served as a marker for functional cure.
Treatment of chronic WHV-infected woodchucks with AIC649 revealed a
bi-phasic pattern of response. WHV-DNA as well as WHsAg increased and
peaked about 2-4 weeks after treatment start to subsequently decline for
the rest of the study period. Viremia levels significantly declined between
weeks 16 and 20 and stayed at even lower levels compared to the control
group until the end of the study. The observed bi-phasic response to AIC649
treatment can be interpreted as the result of a physiologically
“concerted”, reconstituted immune response against WHV and therefore may
indicate a potential for inducing functional cure in HBV-infected patients.
“AiCuris is currently working on the research and development of several
candidates with the aim to cure viral hepatitis,” said Dr. Holger
Zimmermann, CEO of AiCuris. “The data published on PLOS ONE highlight the
potential of AIC649 to induce functional cure. In order to follow-up the
promising preclinical data from woodchuck experiments, we have initiated
the clinical development in chronic hepatitis B patients. We very much look
forward to speeding up the clinical development of this promising candidate
to provide patients suffering from this life-threatening liver infection
with a new treatment option as soon as possible and are open for partnering
opportunities.”
The publication can be downloaded from the Company’s website under
www.aicuris.com.
About hepatitis B: Hepatitis B is a potentially life-threatening liver
infection caused by the hepatitis B virus (HBV). Today the infection
represents one of the major global health problems and an important
occupational hazard especially for health workers. According the World
Health Organization (WHO) an estimated 240 million people are chronically
infected worldwide (July 2015) with more than 780,000 people dying every
year due to complications of hepatitis B, including cirrhosis and liver
cancer. Market experts estimated the HBV market to reach $3.9 billion in
2016. The medical need for new and innovative therapies to treat chronic
infection with HBV is high as – despite numerous research activities –
currently available therapies suppress the virus but provide cure of the
disease only in a slight percentage of patients.
About AIC649: AIC649 is a proprietary inactivated parapoxvirus particle
preparation. It induces a natural, self-limiting immune response, enhancing
appropriate immune responses against unrelated viruses. As a novel
biological immunomodulator, AIC649 has been conceived as curative treatment
for HBV. AIC649 has the potential to become an ideal combination partner
with standard of care for patients chronically infected with the HBV.
AiCuris is currently testing AIC649 in a clinical phase I study in chronic
HBV patients.
About AiCuris: 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 III clinical trials in
patients undergoing bone marrow transplantation.
Contact: Media Relations AiCuris Anti-infective Cures GmbH MC Services AG Katja Woestenhemke Anne Hennecke Friedrich-Ebert-Str. 475/Geb. 302 Kaiser-Friedrich-Ring 5 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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