ExeVir Bio has dosed the first participants in Phase I clinical trial of its llama-derived antibody, XVR011(VHH72-Fc), for Covid-19 prevention and treatment.
Developed by scientists at the VIB-Ghent University in Belgium, XVR011 is a single domain-based anti-SARS-CoV-2 antibody enhanced for stability, safety, wide neutralising ability and greater manufacturability.
The molecule can potentially disable SARS-CoV-2 spike proteins and sterically hinder spike attachment to angiotensin-converting enzyme 2 (ACE2), thereby stopping the virus entry to a human cell and further viral replication.
ExeVir noted that the antibody acts on a peculiar epitope in the conserved region, offering a broad spectrum of binding to spike receptor-binding domains across various sarbecoviruses.
Furthermore, the single-domain antibodies obtained from llamas are smaller than human antibodies and can bind to parts of a virus that are hard for the human immune system to access.
The randomised, double-blinded, single-centre, placebo-controlled Phase I trial will analyse the safety and pharmacokinetics of intravenous (IV) doses of XVR011 in healthy participants.
In addition, the trial will test three ascending doses of the antibody consecutively in a total of three groups of ten healthy adult participants.
ExeVir Bio chief medical officer Dominique Tersago said: “Following the creation of ExeVir a year ago, we are very pleased that our lead compound XVR011 is now in clinical development.
“We are excited by the prospect of bringing a single-dose treatment for patients with Covid-19 to the clinic, first as an IV infusion, which will be rapidly followed by a formulation for subcutaneous injection.”
Furthermore, the researchers found that the antibody’s potency is unlikely to be affected by any presently circulating SAR-CoV-2 variant of concern or interest.
Belgian-based biopharmaceutical company UCB designed and streamlined the therapeutic abilities of XVR011 and produced the drug required for the trial at scale.
In separate hamster and mouse models against SARS-CoV-2, the drug showed significant potent, extensive neutralising activity and protection from infection.