Description du projet
Le premier vaccin oral contre l’E.coli entérotoxinogène
Les bactéries Escherichia coli entérotoxinogènes (ETEC) sont responsable de la diarrhée du voyageur (DV), qui touche particulièrement les habitants des pays en voie de développement. L’ETEC se transmet par le biais d’aliments ou d’eau contaminés et il n’existe actuellement aucun vaccin approuvé pour sa prévention. L’entreprise Biopharma, en Suède, travail au développement d’un vaccin oral contre la DV associée à l’ETEC. L’entreprise collabore avec les plus grands experts mondiaux de la recherche sur les vaccins liés à l’ETEC. Le projet ETVAX, financé par l’UE, mènera une étude de phase II sur le vaccin afin de permettre à l’entreprise Biopharma de prendre les mesures nécessaires à la commercialisation. L’introduction du vaccin réduira le nombre de cas de DV parmi les voyageurs et les patients souffrant du syndrome du côlon irritable ou d’autres maladies chroniques associées à la DV.
Objectif
This project will perform a Phase II study of ETVAX – an oral vaccine against traveller’s diarrhoea (TD) caused by enterotoxigenic E. coli bacteria (ETEC). ETVAX has a strong potential to be the first vaccine with a full ETEC indication. TD caused by enterotoxigenic E. coli bacteria is the most common illness that affects travellers traveling in the developing
regions. Currently, there is no approved method for preventing TD.
Travellers are recommended to use off-label antibiotics such as Rifaximin or the cholera vaccine Dukoral to prevent TD. In business terms, there exists a strong business opportunity in developing and commercializing an effective and safe ETEC vaccine. Scandinavian Biopharma is the first SME positioned to capture this opportunity. The envisaged Phase II study will
allow Scandinavian Biopharma take the key step towards the commercialization of ETVAX.
The targeted users of are travellers visiting tropical and subtropical countries. Their number is forecasted to reach 190 million by 2020. Their key need is to prevent TD which can ruin a significant part of a vacation or a business trip. ETVAX will meet this needs by being safe, efficient and easy to use.
The project delivers an ultimate EU added value by offering the first ETEC vaccine with proven immunogenicity, safety and efficacy. From the scientific perspective, this means that the project fills the gap in the vaccine research on the EU and global level as no other efficient methods for prevention of TD have been proposed on the market to date. The introduction of ETVAX will ultimately decrease number of TD cases among travellers, decrease number of patients with irritable bowel syndrome or other chronic diseases connected to TD, as well as decrease healthcare costs and productivity losses on the EU level.
If successfully validated and accepted by regulatory bodies, ETVAX will take Scandinavian Biopharma to a new level of
competitiveness and growth.
Champ scientifique
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SME-2 - SME instrument phase 2Coordinateur
171 48 Solna
Suède
L’entreprise s’est définie comme une PME (petite et moyenne entreprise) au moment de la signature de la convention de subvention.