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The first children have been vaccinated in Scandinavian Biopharma's large Phase IIb study in The Gambia
Scandinavian Biopharma announces that the first child has been vaccinated in The Gambia with the company's ETEC vaccine candidate, ETVAX®. It is a randomised, placebo-controlled, and double-blind phase IIB study. The study will include about 5,000 children aged 6-23 months. The overall goal of the study is to investigate the protective effect against moderate to severe diarrhoea caused by ETEC over a 1- to 2-year period.
The Phase IIb study in The Gambia is co-financed by the EU Framework Programme for Research and Innovation, Horizon2020 through the organisation European and Developing Countries Clinical Trials Partnership Association (EDCTP) and the study is led by Principal Investigator Dr Hossain from MRC – Unit The Gambia at the London School of Hygiene and Tropical Medicine.
"It feels great that we are up and running. A big thanks to everyone who made this possible during the ongoing pandemic ", says Anna Hill who is Clinical Operations Manager for Scandinavian Biopharma.
Every year, more than 4 billion people in all age groups suffer from diarrhoeal disease. The worst affected are children under the age of five in low- and middle-income countries. Diarrhoeal diseases kill almost 600,000 children every year. This corresponds to about 9% of the world's total infant mortality. Although the overall mortality rate from diarrhoeal disease has decreased since 2000, the incidence remains high. Although major improvements have been made to sanitation and water quality, development is progressing slowly. In total, diarrhoea is estimated to cause 306.5 million Disability-Adjusted Life Years (DALYs).
“Now we are approaching the goal of developing a vaccine that can really make a difference. It is especially important to improve children's chances of winning the battle against life-threatening diarrhoea caused by ETEC”, says Björn Sjöstrand, CEO of Scandinavian Biopharma.
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About Scandinavian Biopharma
Scandinavian Biopharma is a research-based specialty biopharma company determined to give people all over the world a longer and better life. Together with researchers at the University of Gothenburg and the international non-profit organization PATH, Scandinavian Biopharma is developing the first vaccine against ETEC which causes diarrhoea in both travellers and endemic populations.
The development project is mainly funded by the EDCTP programme, which is supported under Horizon 2020, the European Union’s (EU) Framework Programme for Research and Innovation, as well as by PATH and the U.S. Army (USAMRAA).
Scandinavian Biopharma also acts as a distributor for a wide range of specialty biopharma products in Europe with a focus on vaccines and immunoglobulins.
About ETEC
Enterotoxigenic Escherichia coli, or ETEC, is a major cause of bacterial diarrhoeal disease.
ETEC infections are particularly common in low- and middle-income countries (LMIC). In children younger than 5 years, it has been estimated that 1.7 billion episodes of diarrhoea occur annually. ETEC represents a major cause of these episodes and accounts for approximately 400 000 deaths among children living in LMICs. In addition, diarrhoea is associated with an increased risk of stunting (i.e. impaired growth and development). Stunting affects cognitive development which might determine a child’s ability to learn, their educational attainment, and future earnings and it also puts children at risk due to other severe infectious diseases.
ETEC is also the leading cause of travellers’ diarrhoea, affecting more than 35 million travellers every year.
About ETVAX®
To date, no vaccine against ETEC exists and ETVAX® is the only ETEC vaccine candidate in late-stage development. The strong immunogenicity and safety data, as well as the promising field efficacy data, clearly distinguish ETVAX® as the lead vaccine candidate against ETEC. Successful development of this vaccine will address a huge unmet medical need for children in LMICs as well as for travellers.
