ExeVir, which is developing single domain antibody therapies providing broad protection against viral infections, today announces that the first subjects have been dosed in a Phase I clinical study of XVR011, its llama-derived antibody for the treatment and prevention of COVID-19.

Image Credit: ExeVir Bio

The randomized, double-blinded, single-center, placebo-controlled Phase I clinical study will evaluate the safety profile and pharmacokinetics of XVR011 administered as an IV infusion in healthy subjects. The study will sequentially test three ascending doses of intravenously administered XVR011 in a maximum of three groups of 10 healthy adult subjects.

This is a major milestone for ExeVir. Following the creation of ExeVir a year ago, we are very pleased that our lead compound XVR011 is now in clinical development. Importantly, XVR011 was recently demonstrated to neutralize the Delta variant, as well as all current COVID-19 variants of concern. 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. We are making significant progress as we work to avert evolution and spread of existing and new coronaviral disease with next generation treatments. We would like to thank our investors, our team at ExeVir, VIB and our many collaborators for their exceptional work and steadfast support.”

Dominique Tersago, Chief Medical Officer, ExeVir Bio

ExeVir recently announced that novel data generated in the laboratory of Professor Johan Neyts at the Rega institute (KU Leuven, Belgium) show that XVR011 demonstrated strong in vitro neutralization potency against the Variants of Concern Delta (B.1.617.2) and Gamma (P.1). Additionally, results from Professors Xavier Saelens and Nico Callewaert based on epitope sequencing indicate that the potency is not expected to be impacted by any currently circulating variant of concern or variant of interest. This is of particular relevance for the further clinical development and broad applicability.

The XVR011 molecule was developed by VIB-Ghent University (Belgium) scientists led by Professors Xavier Saelens and Nico Callewaert. The Belgian-based global biopharmaceutical company UCB helped design and optimize the therapeutic properties of XVR011 and manufactured the antibody at large scale for the clinical trial. The development work is presently undergoing peer review and was recently pre-printed in BioRxiv, demonstrating highly potent and broad neutralizing activity and infection protection in both hamster and mouse models against SARS-CoV-2.