Scandinavian Biopharma meddelar att de fullständiga resultaten från bolagets fas 2b-studie av ETVAX®, bolagets ledande orala vaccinkandidat mot enterotoxinbildande Escherichia coli (ETEC), har publicerats i The Lancet Infectious Diseases – en av världens mest ansedda medicinska tidskrifter. EMA bekräftar att ETVAX® är redo för fas 3.
Scandinavian Biopharma today announces that the comprehensive results from its Phase 2b trial of ETVAX®, the lead oral vaccine candidate against enterotoxigenic Escherichia coli (ETEC), have been published in The Lancet Infectious Diseases. ETVAX® is considered Phase 3 ready for the prevention of moderate-to-severe ETEC diarrhoea in infants and young children in low- and middle-income countries.
Scandinavian Biopharma is pleased to announce the successful completion of its large pediatric Phase IIb trial for ETVAX®, a promising vaccine candidate against enterotoxigenic Escherichia coli (ETEC), commonly called traveler’s diarrhea, conducted in The Gambia.
It is with great pleasure that we present another really good year of growth. The figures for the full year 2022 add up to an increase in sales equivalent to 30% in organic growth. In total, sales amount to approximately SEK 122 million. Our ETEC vaccine candidate, ETVAX, is about to enter phase 3.
All participants have received the third and final vaccination dose in our large randomized, placebo-controlled, and double-blind phase 2b study in The Gambia. The study includes 4 936 children aged 6-18 months. The overall goal of the study is to investigate the efficacy against moderate to severe diarrhea caused by ETEC.
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.
In record time we completed a phase IIB randomized, double-blind, placebo-controlled trial in Finnish travellers going to West Africa. In total 743 travellers 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 and estimate the protective efficacy in a naive population.
