OSIVAX Announces Completion of Enrolment in its Phase 2a Clinical Trial of OVX836 Universal Influenza Vaccine Candidate
— Top line results expected by the first quarter of 2021 —Lyon, France – April 09, 2020 – OSIVAX, a clinical stage biopharmaceutical company currently focusing on the development of a universal influenza vaccine candidate, announced today that it completed the enrolment of the 300 subjects in the Phase 2a trial of OVX836 on the 9th March 2020. The study is designed to evaluate the immunogenicity and safety of OVX836 Universal Influenza Vaccine Candidate.
The single-centre, randomized, double-blind, controlled Phase 2a study (NCT04192500) runs at the Center for Vaccinology (CEVAC) at the Ghent University Hospital (Ghent, Belgium), under US IND. The 300 healthy volunteers from 18 to 65 years old were enrolled and had blood samples taken at Day 0 and Day 7, securing the primary objective of the study (immunogenicity at 7 days after vaccination). The evaluation of the short-term immunogenicity, which is the Primary Endpoint of the study, is therefore secured without any detrimental impacts from the current COVID-19 pandemic.
Top line results from this Phase 2a clinical trial are expected by the first quarter of 2021.
“We are delighted to announce that all subjects have been enrolled in line with the planning, and that the Primary Objective of the study is secured without any impact of the ongoing COVID-19 pandemic. We are now focused on pursuing the study and expect “last subject last visit” in Q3 this year,” stated Alexandre Le Vert, CEO and co-founder of OSIVAX. “We are very optimistic about the clinical trial results as we truly believe OVX836 universal influenza vaccine candidate has the potential to revolutionize flu prevention.”
“We would like to thank the study participants and the site staff for their continued support in these difficult times, that allowed to continue the study with minimal impact of the ongoing outbreak. We are looking forward to the availability of the full set of results.” said Dr Isabel Leroux-Roels, principal investigator of the clinical trial.
About the Center of Vaccinology
The Center for Vaccinology of the Ghent University and Ghent University Hospital (CEVAC) has a large track record in conducting vaccine trials for numerous infectious diseases: hepatitis B, combined hepatitis A-B, influenza, HPV, HSV, VZV, RSV, CMV, HIV, tuberculosis, malaria, for a wide number of sponsors. CEVAC has developed a large portfolio of assays to measure humoral and cellular immune responses following rapid blood sample on-site processing.
OSIVAX’s mission is to revolutionize influenza prevention with a universal flu vaccine for both current and future influenza infections by leveraging its unique oligoDOM® technology platform. The OVX836 universal flu vaccine candidate is in Phase 2a clinical development. OSIVAX is focused on providing proof-of-concept in influenza firstly to save lives and secondly to apply the oligoDOM® platform to other infectious and immune system-associated diseases. For further information: www.osivax.com/
|This project has received funding from the European Union’s Horizon 2020 research and innovation programme under grant agreement No 961112