Eveliqure announces regulatory approval to commence first clinical studies with its combined Shigella and ETEC vaccine
Vienna, 2nd June 2020
Eveliqure Biotechnologies today announces that the Hungarian regulatory agency OGYÈI has approved the clinical trial for its vaccine program to prevent diarrhoeal diseases caused by Shigella and Enterotoxigenic E. coli (ETEC).
Diarrhoeal diseases are the most common illnesses in the world today, with an estimated 1.7B cases annually. Affecting 30-50% of travellers visiting developing countries, this is typically considered a non-life-threatening inconvenience, but diarrhoeal diseases kill over 2000 children every day in low- and middle- income countries. Vaccines have been successfully developed for diarrhoeal disease caused by cholera, typhoid and rotavirus. Shigella and Enterotoxigenic E. coli (ETEC) accounts for up to 50% of all diarrhoea cases, but no effective vaccines exist. In response to this, Eveliqure has developed ShigETEC, the only vaccine close to clinical testing that targets both these major bacterial pathogens.
“It is fantastic that we have reached this important milestone and transitioned into a clinical stage company. Obtaining the approval for the first-in-human study of our experimental vaccine is a significant step towards our goal to prevent Shigella and ETEC diarrhoea in children living in disease endemic regions and to protect travellers. The significant public funding we have obtained from Horizon2020 and The Wellcome Trust combined with support from our investors will enable us to move forward with the clinical development of ShigETEC” - said Gábor Somogyi, MD, MBA, Chief Executive Officer of Eveliqure.
“This regulatory approval validates the approach Eveliqure is taking with the ShigETEC vaccine. We look forward to establishing safety and immunogenicity data in our Phase 1 study of adult volunteers in defining a safe, well tolerated, and effective schedule of dosing that will prepare ShigETEC for efficacy studies”. – commented Frank Malinoski MD, PhD, Chief Medical Officer of Eveliqure.
The Phase 1 regulatory approval from OGYÈI is conditional on the lifting of COVID-19 restrictions. The study will be performed in Hungary and will be initiated as soon as restrictions are lifted.
Eveliqure Biotechnologies is an Austrian-based biotech company that is the game-changer amongst vaccine companies, championing novel technologies to make the world safe from diarrhoea. Eveliqure is passionate about improving the quality of life for both the poor and the privileged by providing innovative medical solutions that fight diarrhoeal diseases.
Sophie Zettl, PhD
Head of Business Development
Eveliqure Biotechnologies GmbH
+ 43 676 3731595