Descrizione del progetto
Il primo vaccino orale contro l’E.coli enterotossigeno
I batteri Escherichia coli enterotossigeni (ETEC) sono la causa della diarrea del viaggiatore (DV), che colpisce soprattutto le persone nei Paesi in via di sviluppo. L’ETEC si trasmette attraverso alimenti o acqua contaminati e attualmente non esiste un vaccino approvato per la sua prevenzione. Biopharma, in Svezia, sta sviluppando un vaccino orale contro la DV associata ai batteri ETEC. L’azienda collabora con i maggiori esperti mondiali nella ricerca sui vaccini contro gli ETEC. Il progetto ETVAX, finanziato dall’UE, condurrà uno studio sul vaccino di fase II per consentire a Biopharma di compiere i passi necessari alla commercializzazione. Il successo dell’introduzione del vaccino ridurrà il numero di casi di DV tra i viaggiatori colpiti e i pazienti con sindrome dell’intestino irritabile o altre malattie croniche associate alla DV.
Obiettivo
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.
Campo scientifico
Parole chiave
Programma(i)
Argomento(i)
Invito a presentare proposte
Vedi altri progetti per questo bandoBando secondario
H2020-SMEINST-2-2016-2017
Meccanismo di finanziamento
SME-2 - SME instrument phase 2Coordinatore
171 48 Solna
Svezia
L’organizzazione si è definita una PMI (piccola e media impresa) al momento della firma dell’accordo di sovvenzione.