XVR011 is being observed in a randomized, double-blind, single-center, and placebo-controlled study to evaluate its pharmacokinetic activity and safety profile.
ExeVir Bio, the Belgium-based clinical stage biotechnology firm, has announced that the participants of its Phase I study on a potential treatment for COVID-19 have been dosed.
XVR011, ExeVir’s llama-derived antibody, is being observed in a randomized, double-blind, single-center, and placebo-controlled study to evaluate its pharmacokinetic activity and safety profile. It is given intravenously via IV infusion to healthy participants. The research is expected to test three ascending doses in sequential order on up to three groups of 10 adult subjects who are in good health.
In a statement, the company said that the XVR011 has been optimized for safety, stability, and broad neutralizing capability. It is also easy to manufacture. It was developed by VIB-Ghent University scientists led by Professors Xavier Saelens and Nico Callewaert.
The component works by deactivating SARS-CoV-2 spike proteins and blocking spike binding to ACE2. This prevents the virus from getting into a human cell, thereby halting viral replication. It also supports the patient’s immune system responses, especially at a time when these are either inadequate or slow to react.
What is particularly interesting is that XVR011 has also shown itself to be effective against the COVID-19 Delta variant, among a range of other virus versions.
“This is a major milestone for ExeVir, and we are very pleased that our lead compound XVR011 is now in clinical development. Importantly, XVR011 was recently demonstrated to neutralize the Delta variant, first as an IV infusion, and then to be rapidly followed by a formulation for subcutaneous injection. We are making significant progress as we work to avert the evolution and spread of existing and new coronaviral disease with next generation treatments,” said Dominique Tersago, chief medical officer at ExeVir Bio.
New data generated from the ongoing lab trials showed that XVR011 exhibited strongly in vitro neutralization potency against different Corona variations, including Delta (B.1.617.2) and Gamma (P.1). The findings also indicate that its potency is not expected to be affected by any currently circulating COVID-19 variants.
The paper containing evaluation results for XVR011 is currently undergoing peer review and was published in the scientific journal BioRxiv.
ExeVir is a clinical stage firm that uses its VHH technology platform to create antiviral therapies. Last month, it entered into a manufacturing collaboration deal with Mithra Pharmaceuticals to use ExeVir’s fill and finish capabilities for innovative treatments at the Mithra CDMO, Mithra’s R&D and manufacturing platform. Mithra CDMO’s solutions cover a wide gamut of biopharma capabilities, from early drug development, clinical studies, and commercial manufacturing.
