Nantes biotech Xenothera is conducting a clinical trial in twenty hospitals to test the therapeutic efficacy of a treatment anti-Covid-19. This is based on polyclonal antibodies and is intended for patients at the start of hospitalization. In recent months, these are the experiments based on monoclonal antibodies that raised a lot of hope. And that right up to the Elysée Palace.
In total, 67 patients treated in 21 French hospitals are currently concerned on Wednesday by this new trial called “Polycor” and whose phase 2B, authorized by the National Medicines Safety Agency (ANSM) began at the end of December. “Xav-19 is a polyclonal antibody directed against the Sars-CoV-2 virus. When you are attacked by a virus, you can neutralize it with antibodies but you do not always have the right antibodies and in the right quantity ”, explained Odile Duvaux, the president of Xenothora about the treatment called“ Xav-19 “.
The “Polycor” trial, promoted by the Nantes University Hospital, should ultimately involve 400 patients in more than 40 hospitals to “measure precisely and statistically the effectiveness of Xav-19”, she continued. If the efficacy is proven, the ANSM may issue an ATU (temporary authorization for use) to be able to administer Xav-19 to patients who need it, without waiting for a company to submit an MA file (authorization for marketing).
“Antibodies of porcine origin”
The Polycor trial is part of 15 clinical studies which were labeled at the end of December as a “national research priority” by Capnet (National Steering Committee for Therapeutic Trials and Other Research on Covid-19), charged by the Ministry of Health to “prioritize studies with high potential in order to accelerate them”.
The Xav-19 antibodies are “glyco-humanized antibodies, that is to say that they are antibodies, originally porcine, but which have been modified to be like human antibodies”, detailed Odile Duvaux , explaining that “the pig has been a supplier of medicines for an extremely long time […] because it has a phylogenetic proximity to man ”.
Xenothera assured in early February that Xav-19 was effective against the various variants currently circulating, given the polyclonal nature of the product. “A monoclonal antibody can lose all effectiveness due to a single mutation of the virus” while “the polyclonal is completely different, it attacks the virus from many sides”, explained Odile Duvaux. Xenothera said it is in discussions with the Ministry of Health for “an option on doses of Xav-19” and the company is preparing “for large-scale production” of batches of its treatment.