News

Scandinavian Biopharma announces the last follow up visit in the phase IIB clinical trial with ETVAX® in Finnish travellers to Benin

In record time Scandinavian Biopharma completed a phase IIB randomized, double-blind, placebo-controlled trial in Finnish travellers going to Benin in West Africa. All participants have now been enrolled and the last travellers left Benin in March 2019. The last follow up visit was conducted just before Easter. In total 743 healthy travellers, between the ages of 18 to 65 years, have spent a fortnight in Benin. Half of the group were given the ETEC vaccine candidate, ETVAX®, and the other half placebo. The aim of the study was to evaluate safety, new diagnostic methodology and estimate the protective efficacy of the vaccine against ETEC caused travellers’ diarrhoea (TD) in a naive population.

The trial is a successful collaboration between the University of Helsinki, University of Gothenburg and Scandinavian Biopharma. Other partners include the Aava travel clinic, United Medix Laboratories Ltd, Medfiles Ltd and University of Virginia. The study was funded by Scandinavian Biopharma, European Research and Innovation Program Horizon 2020 (SME), the international health organisation PATH and Bill & Melinda Gates Foundation.

The Finnish-African cultural centre Villa Karo in Benin and Finland has been responsible for taking care of all participants during the trip. To proceed with the study, Scandinavian Biopharma built a fully equipped laboratory at the local site in Grand Popo, Benin. The study enrolment has been very successful with the inclusion of 743 participants. Primary results show that the incidence of TD is very high; ETEC is the most common pathogen; the vaccine has been safe and well tolerated and the vaccine coverage is as high as almost 90%. All samples from the clinical trial are now being analysed and later this year the study will be unblinded and presented.

The most common illness that affects travellers visiting sub/tropical regions is TD. It is estimated that up to 30-40% of travellers can experience TD during a two-week stay. ETEC is the most common cause of travellers’ diarrhoea affecting 35 million travellers to (sub) tropical destinations every year. Recent data also strongly suggest that ETEC infections in travellers also can increase the risk of subsequent functional bowel disorders. In fact, 10-14 % of travellers convalescing from ETEC-associated TD may go on to develop irritable bowel syndrome, thus further highlighting the importance of disease prevention and the potential benefit of having effective vaccines.

Björn Sjöstrand, CEO at Scandinavian Biopharma, says: “Our vaccine can make a big difference by saving millions of well-deserved holiday trips and prevent negative long-term gastrointestinal syndromes. Positive results will accelerate the development of our tailor-maid presentation for infants in Low- and Middle-Income Countries where ETVAX® could have the potential to save hundred thousands of lives and reduce morbidity leading to poor physical and cognitive development among infants.”

For more information, please contact:
Björn Sjöstrand, CEO: +46 727-125 120, bjorn.sjostrand@scandinavianbiopharma.se