ExeVir, which is developing single domain antibody therapies providing broad protection against viral infections, announces that the first patient has been treated in a Phase 1b/2 global clinical study of XVR011, its potent COVID-19 neutralizing antibody.
EXEVIR0101 is a two-part study, which will evaluate the safety and efficacy of XVR011 in neutralising the SARS-CoV-2 virus in patients hospitalized as a result of mild to moderate COVID-19, with the aim to allow a more rapid recovery. Phase 1b of the study in conjunction with the Phase 1a study in healthy volunteers, which was recently started, will inform and broaden the safety database for XVR011 as well as provide important antiviral and clinical activity data before the current study proceeds to Phase 2 which will evaluate both efficacy and safety.
The Phase 1b study will enrol up to 27 patients with mild to moderate symptoms caused by the SARS-CoV-2 coronavirus. The study will sequentially evaluate three different doses of intravenously administered XVR011 with the primary endpoint of proportion of patients with adverse events. Secondary endpoints include viral load, need for oxygen supplementation, clinical score (8-point ordinal scale) and other measures of clinical activity. Upon a positive recommendation from the independent data monitoring committee, the study will roll over into the Phase 2 part in 252 patients which will evaluate the efficacy at the dose selected from Phase 1b. Further details of the study can be found on clinicaltrials.gov under the identifier NCT04884295.
Dominique Tersago, Chief Medical Officer of ExeVir Bio, said: “Treatments for patients admitted to hospital for mild to moderate COVID-19 are still urgently needed and we are very pleased that our lead compound XVR011 is now being evaluated in this setting. XVR011 was recently demonstrated to neutralise the Delta variant in vitro, as well as all current COVID-19 variants of concern and we look forward to confirming the activity in the clinic. Our study is designed to rapidly treat eligible patients upon admission to hospital with the aim to curtail the infection and allow a faster recovery and avoid progression to more severe disease. We remain committed to bringing a next generation, single-dose treatment to patients with COVID-19.”
The XVR011 molecule was developed by VIB-Ghent University (Belgium) scientists led by Professors Xavier Saelens and Nico Callewaert. They also showed that based on epitope sequencing, the potency is not expected to be impacted by any currently circulating variant of concern or variant of interest. This has been confirmed recently in the laboratory of Professor Johan Neyts at the Rega institute (KU Leuven, Belgium) with data that show XVR011 has strong in vitro neutralization potency against the variants of concern Delta, Alpha, Beta and Gamma.
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.