Covid-19: the treatment of the French company Xenothera failed by the Medicines Agency in France

It's a blow for what was certainly the most advanced French project.

The Medicines Agency (ANSM) rejected the request for authorization of synthetic antibodies against Covid-19 produced by the French company Xenothera, for lack of "therapeutic interest" proven at this stage, she indicated. Friday.

The Nantes-based laboratory had requested authorization for its drug Xav-19 in the treatment of "moderate lung damage due to Covid-19".

"At this stage, the data provided by the laboratory do not allow clinical demonstration of the therapeutic interest of polyclonal antibodies" for this indication, writes the agency, according to which it has not been proven that the benefit-risk ratio is positive. .

"Additional data will be necessary to assess the benefit of this treatment for patients with Covid-19 and to specify its tolerance profile," she said.

The treatment of the French biotech Xenothera, created in 2014, consists of synthetic antibodies, called "polyclonal antibodies".

Its product, Xav-19, is based on antibodies of porcine origin modified to be “humanized”.

Validated by the EMA in July 2021

XAV-19, from the Nantes laboratory Xenothera, was originally expecting interim results from its clinical trials at the end of September.

“The Nantes University Hospital should finally provide them to us before March 2022”, specified Parisian Odile Duvaux, president of Xenothera, who assured all the same that “the preliminary information confirms its therapeutic interest and its benign nature”.

Intended for patients with moderate Covid, this treatment aims to avoid their transfer to intensive care.

On July 8, 2021, Xenothera had however received accelerated scientific advice from the European Medicines Agency (EMA).

"The EMA has validated the approach presented by Xenothera, in particular the quality of the drug, the validity of the preclinical and toxicological analyzes, and the general approach of the clinical development plan for XAV-19", announced the biotech in a communicated.

Paxlovid available in France in February

The Medicines Agency also confirms that following the marketing authorization for Paxlovid by the European Commission, this treatment would be available in France in February under an early access authorization.

This anti-Covid pill from the manufacturer Pfizer should be given to patients within five days of the onset of symptoms.

Studies have indicated that this treatment significantly reduces hospitalizations or deaths in patients at risk of developing severe disease, and should remain effective against the Omicron variant.