The COVID-19 treatment XAV-19, developed by French biotech company XENOTHERA, has started a European clinical trial in partnership with Contract Research Organisation (CRO) Excelya.
The study, called EUROXAV, is sponsored by the Nantes laboratory and will be conducted by Excelya, a leading European CRO specialized in clinical research. The companies announced the recruitment of the first patient in the EUROXAV clinical trial on Monday.
XAV-19 developed by XENOTHERA is a novel polyclonal humanized anti-SARS-CoV2 antibody administered intravenously. Polyclonal neutralizing antibodies have numerous advantages, such as providing immediate immunity, consequently blunting an early pro-inflammatory pathogenic endogenous antibody response, as well as no drug-drug interactions. By acheiving immediate immunity and inhibiting entry into cells, neutralizing antibody treatment is a is thought to be a promising therapeutic approach.
About the EUROXAV Phase III clinical trial
EUROXAV is a multi-center, double-blind phase III study that will take place in Greece, Bulgaria, Romania, Spain and Turkey enrolling 722 patients with moderate COVID-19 who will be either hospitalized or remotely monitored. The trial’s first patient was enrolled on April 28th at Professor Poulakou’s (GR04) center in Greece. Further 398 patients in 35 French hospitals have been enrolled in the POLYCOR study. The clinical study is held under the sponsorship of Nantes University Hospital which just finished its recruitment phase and whose findings are due in the Summer of 2021.
Alan Morgan, CEO of Excelya stated:
“Excelya is very proud to support XENOTHERA in the development of XAV19, which holds great promise in the battle against COVID19. After taking several months to develop the EUROXAV project, the inclusion of this first patient represents an important milestone. We hope to work quickly to make results available and initiate the next steps to benefit patients and caregivers”.
Odile Duvaux, co-founder and president of XENOTHERA commented:
“This milestone marks the start of the EUROXAV trial, the results of which are awaited with great interest. The aim of the trial is to evaluate the efficacy of XAV-19 in hospitalized and ambulatory patients, which will allow us to analyze the medical value of XAV-19 in clinical situations where there is currently no satisfactory therapeutic solution.”
About XAV-19 – polyclonal humanized anti-SARS-CoV2 antibodies
XENOTHERA creates novel therapeutic modes in numerous domains from immunomodulation to infectious diseases. The companies XAV-19 is a heterologous swine glyco-humanized polyclonal antibody (GH-pAb) raised against the spike protein of SARS-CoV-2, blocking infection of ACE-2-positive human cells with SARS-CoV-2.