Launch of a phase I clinical trial in Singapore of the Fab’entech product against H5N1 avian influenza

Fab'entech's specific anti-H5N1 polyclonal antibodies could constitute a new approach in the treatment of H5N1 avian influenza in humans.

Lyon, dated 11 October 2012:
The biopharmaceutical company Fab’entech, specialised in the development of specific polyclonal antibodies against emerging infectious diseases, is today announcing the launch of the first trial in humans of its polyclonal immunoglobulins against the H5N1 virus responsible for avian influenza. If the promising results obtained during the trials on animals are confirmed, these immunoglobulins could constitute a new and specific approach in the treatment of individuals potentially infected with the H5N1 virus.

Passive immunotherapy involves injecting the patient with specific polyclonal antibodies (immunoglobulins) that are capable of recognising in a targeted manner and neutralising the virus. Thanks to a perfectly mastered process, Fab’entech can offer industrial production of highly-purified immunoglobulins in the form of immunoglobulin fragments [F(ab’)2] needed to neutralise the virus.

“By launching a phase I clinical trial, we are taking an important step in the availability of an innovative solution to fight H5N1 viral infections in humans,” stated Dr Bertrand Lépine, founder and CEO of Fab’entech. “This trial will take place in Singapore, in a region where the risk of H5N1 viral spread is one of the highest. The availability of specific polyclonal antibodies against the H5N1 virus could therefore give immediate protection to those who have been infected or exposed to the virus. “

The tolerance and efficacy of the Fab’entech product have been extensively documented during studies conducted in collaboration with the Inserm at the Jean Mérieux BSL-4 laboratory in Lyon. The clinical trial which is starting will involve 16 healthy adult volunteers who will be followed for 5 weeks. This study will be conducted as a placebo-controlled double-blind study, in strict compliance with Good Clinical Practice (GCP).

About the H5N1 avian influenza

The H5N1 avian influenza is an infectious viral disease mainly affecting birds (particularly waterfowl, but sometimes also poultry). Avian viruses do not generally infect humans but certain subtypes of H5N1 have caused serious infections in humans, with a mortality rate sometimes reaching 60 to 80% in certain regions, especially Asia.

According to the World Health Organisation (WHO), 608 human cases of H5N1 have been reported since 2003, of which 30 during the first semester 2012. Within the scientific community, the threat of an H5N1 influenza pandemic remains very real, especially if the H5N1 virus were to mutate and become transmissible from human to human.

About Fab’entech

Fab’entech, is a biopharmaceutical company founded in Lyon and situated at the heart of the Lyonbiopole. Fab’entech offers an innovative passive immunotherapy model by developing different ranges of specific polyclonal immunoglobulins [F(ab’)2 fragments] using a recognised and proven technology established by Sanofi Pasteur, the vaccine division of Sanofi, and with the collaboration of the Inserm – Jean Mérieux BSL-4 Laboratory, in order to respond very quickly to basic public health needs in the face of growing risks of emerging diseases (such as the H5N1 avian influenza, the Crimean-Congo haemorrhagic fever (CCHF), Ebola, Nipah, Lassa, SARS, Chikungunya) or in relation to bioterrorism.

With the support of specialist partners and internationally recognised experts, Fab’entech is developing several innovative programmes of international scope supported by public and private funding, thus offering flexible solutions adapted to these public health challenges.

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Bio-production: Fab’entech presents its new industrial site

Fab’entech, a French biotech specialised in the development and production of polyclonal antibodies, presents its new industrial site located in Saint-Priest, to the south-east of Lyon. The 1,000 m2 production site is now operational and will give Fab’entech the capacity to manufacture all of its innovations (biodefense and anti-COVID-19 programme: FabenCOV®) in France. Close-up of this new site, a key asset in the development of the biotech’s activities.

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