French CRO Excelya has started a trial of a candidate COVID-19 treatment developed by Xenothera.
The candidate – XAV-19 – is a polyclonal neutralizing antibody therapy designed to inhibit entry and replication of SARS-CoV-2, the virus that causes COVID-19.
The Phase III clinical study – which is known as EUROXAV – is taking place at sites in Greece, Bulgaria, Romania, Spain and Turkey and will seek to recruit 722 patients with moderate disease. The first patient signed up at the end of April at a facility in Greece.
An Excelya spokeswoman told us “The study has just started recruiting 10 days ago so we’re at the beginning. We do expect this study to be easier to recruit than other studies because the potential for efficacy is high, data for tolerance is already available and promising, the polyclonal antibody strategy has great potential, so investigators are very motivated.
“We will be working with multiple countries in Europe which is another source of motivation for recruitment.”
She also confirmed trial supplies of XAV-19 are being made by a contract manufacturing organization (CMO).
Plasma collection bypass
XAV-19 is a heterologous swine glyco-humanized polyclonal antibody (GH-pAb) that targets the virus’ spike protein blocking infection of ACE-2-positive human cells.
Xenothera opted for a porcine-based product system to bypass difficulties involved in collecting plasma that the firm says “are not adapted to a broad use across all populations.”
EUROXAV builds on the Polycor trial currently being conducted at 35 hospitals across France, results from which are expected this summer.
COVID-19 research
Excelya is working with a total of five active COVID-19 studies, including the Xenothera trial.
The spokeswoman said, “We are working with Medesis Pharma in a European phase I/II clinical trial to examine the efficacy of NanoManganese administered with Medesis’ AONYS technology as a treatment for Covid-19. A
She explained that the AONYS technology allows the administration of low doses of water-soluble pharmaceutical active ingredients.
“The final product is deposited on the mucosa of the mouth and then transported by lipoproteins and delivered directly into the cytoplasm of the cells of the whole body via lipoprotein cell receptors.”
Excelya is also working on Genoscience Pharma’s Cure COVID 2019 study, which is being supported by the French Government.
“The study aims to recruit 120 patients over the next 6 months. The main objective is to evaluate the efficacy of Genoscience Pharma drug candidate in patients with COVID-19 infection versus current standard of care.
“Excelya supports Genoscience Pharma with their project management, clinical operations, data management, statistics and pharmacovigilance on this study,” the spokeswoman said.
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