Scandinavian Biopharma has successfully completed the enrolment of the clinical Phase 1 trial in Zambia
We are proud to announce that, despite all challenges associated with the Covid-19 pandemic, all participants have now received the third and final vaccination dose in our Phase 1 trial in Zambia. The study started in 2019 and is part of the late phase development program in Africa for Scandinavian Biopharma’s vaccine candidate, ETVAX®, against Enterotoxigenic Escherichia coli (ETEC). The study is funded by the EU Research and Innovation Framework Program, Horizon 2020, through the European and Developing Countries Clinical Trials Partnership (EDCTP) organization.
The study included 246 participants and the objectives were to further establish the exact safe dose and tolerability of ETVAX® in young children, as well as to explore the potential benefits of a third booster dose. The study was conducted in 40 healthy adults (18-45 years of age), followed by 60 children 10-23 months of age and lastly 146 children 6-9 months of age.
The adult participants received ETVAX® with 10ug dmLT or placebo in a double blinded manner. All children (6-23 months of age) received two doses of placebo or 1/8 or 1/4 of the adult dose of ETVAX® together with 2,5ug of dmLT. The initial two doses were then followed by a booster dose in all children.
By now, all participants have been enrolled and the last follow-up visit will be held in September. Preliminary findings suggest promising immunogenicity results and confirm the favourable safety profile of ETVAX®. All samples from the clinical study are being analysed and the results will be presented during H1 of 2021.
A large Phase 2b trial in The Gambia including children 6-18 months of age is ready to start when the Covid-19 pandemic allows. The selected dose in the Phase 2b trial is based on the favourable safety and immunogenicity data from the study in Zambia and all other previously conducted studies of ETVAX®. The outcome of the paediatric trial in Zambia as well as in The Gambia will pave the way for the pivotal Phase 3 trial which will lead up to licensure of ETVAX® and pre-qualification by World Health Organization (WHO).
Björn Sjöstrand, CEO at Scandinavian Biopharma, says: “The completion of the enrolment in the Zambian study is another important milestone towards making a vaccine available for children in low- and middle-income countries. An ETEC-vaccine is prioritized by WHO and has the potential to save hundred thousands of lives and reduce morbidity leading to poor physical and cognitive development among infants. Furthermore, the vaccine has the potential to prevent the loss of millions of well-deserved holiday trips and negative long-term gastrointestinal syndromes due to travellers diarrhoea.”
About Scandinavian Biopharma
We are a research-based specialty biopharma company determined to give people worldwide a longer and better life. We are, together with researchers at the University of Gothenburg and the international non-profit organization PATH, developing a new oral ETEC vaccine for use in both travellers and infants and young children in LMICs who continue to be at high risk for infection and severe illness from this bacterial enteric pathogen. Currently, there is no ETEC vaccine available on the market and ETVAX® is the only ETEC vaccine candidate in late-stage development.
We also distribute a wide range of specialty biopharma products with focus on vaccines and immunoglobulins.