Scandinavian Biopharma officially starts their late phase development program in Africa funded by EDCTP

The Permanent Secretary at Ministry of Health Dr Kennedy Malama together with the Swedish Ambassador Henrik Cederin, Dr Izukanji Sikazwe CEO at Centre for Infectious Disease Research in Zambia (CIDRZ) and Dr Godfrey Biemba CEO at National Health Research Authority (NHRA) in Zambia officially announced April 17^th the start of Scandinavian Biopharma’s late phase paediatric development program for their vaccine candidate ETVAX^® in Africa. 

The vaccine is tailor-designed to protect against Enterotoxigenic Escherichia coli (ETEC) - a common pathogen that causes dehydrating diarrhoea, and thus will contribute to reduced morbidity and mortality among young children living in ETEC-endemic areas and prevent travellers’ diarrhoea (TD) caused by the same pathogen. The program has received EUR 7.3 million funding from the European & Developing Countries Clinical Trials Partnership (EDCTP).

The EDCTP funded program starts with a Phase I age-descending trial, as a sequel to the already successful age descending phase I/II trial in 500 Bangladeshi participants down to 6 months of age. This trial will further establish the exact safe and immunogenic dose of the vaccine in young children (6-23 months of age) as well as to explore the potential benefits of a third booster dose. The study will be initiated in healthy adults and followed by young children (6-23 months of age) in Zambia starting from May 2019. The study will be led by Dr Roma Chilengi, Chief Scientific officer at CIDRZ in Zambia.

The Zambian study will immediately be followed by a Phase IIb study in approximately 5,000 children 6-18 months of age in The Gambia. The objective of this study is to investigate the protective efficacy of the vaccine over a 1-2-year period against moderate to severe diarrhoea caused by ETEC.

“We have shown ETEC to be among leading causes of diarrhoea in Zambia. An ETEC vaccine would have a huge positive impact to public health especially in the rural areas” emphasizes Dr Roma Chilengi.

The global diarrhoeal disease burden remains high, with approximately four billion cases estimated to occur annually in all age groups, with the highest incidence among infants and young children under five years of age resulting in nearly 600,000 deaths each year, comprising approximately 9 percent of global infant mortality and an enormous physical and economic toll in low resource countries.

Diarrhoea can also be a triggering event for death from other causes, particularly pneumonia. Despite encouraging declines in overall diarrhoea associated mortality since year 2000, incidence rates remain high and have changed very little, even with incremental improvements in sanitation and water quality. Diarrhoea is estimated to account for 306.5 million Disability-Adjusted Life Years (DALYs), primarily among children below five years of age. The link between a high diarrhoeal disease burden and poor physical and cognitive development among infants and young children in low and middle income countries is so strong that many experts are considering diarrhoea a form of acute malnutrition.

Among the primary infectious causes of diarrhoeal disease, ETEC is one of the most important pathogens for which there is currently no licensed vaccine. ETEC is also the leading cause of traveller’s diarrhoea that is affecting 35 million travellers to (sub) tropical destinations every year.

The outcome from the planned program in Africa funded by EDCTP will pave the way for investments in a phase III program and a licensure of ETVAX^® and pre-qualification by World Health Organization (WHO) “Let us all hope we are successful in developing the first vaccine to help combat diarrhoea caused by ETEC” concludes Björn Sjöstrand, CEO of Scandinavian Biopharma.