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September 2, 2021

ExeVir enrols first subject in Phase Ib/II trial of Covid antiviral therapy

The Phase Ib part will have up to 27 participants to assess three different doses of XVR011 given intravenously.

ExeVir has enrolled and treated the first subject in an international Phase Ib/II clinical trial of its potent Covid-19 neutralising antibody, XVR011.

The XVR011 molecule was created by researchers at the VIB-Ghent University in Belgium.

Biopharmaceutical company UCB aided in designing and streamlining the therapeutic properties of XVR011, as well as produced the antibody required for the clinical trial at a large scale.

XVR011 showed increased potency and extensive neutralising activity and protection from infection in hamster and mouse models against SARS-CoV-2.

The two-part Phase Ib/II trial will assess the safety and efficacy of XVR011 in neutralising SARS-CoV-2 in mild to moderate Covid-19 patients who are in hospital.

It is intended to offer a quicker recovery in these patients, ExeVir noted.

The Phase Ib part will enrol up to 27 subjects and analyse three different intravenous doses of XVR011, consecutively.

The proportion of subjects with adverse events will be the Phase Ib primary goal.

Viral load, supplemental oxygen requirements, clinical score on an eight-point ordinal scale and additional clinical activity measures will be analysed as secondary goals.

Along with the Phase Ia trial in healthy subjects that has already started, the Phase Ib part will expand the safety database for XVR011, the company added.

It will also offer vital antiviral and clinical activity data before progressing to Phase II.

On obtaining a positive recommendation from the independent data monitoring committee, the trial will advance into Phase II, which will enrol 252 subjects.

The Phase II segment will assess the efficacy and safety of the drug dose chosen from the Phase Ib part.

ExeVir Bio chief medical officer Dominique Tersago said: “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.”

Based on epitope sequencing, the VIB-Ghent University scientists noted that the antibody’s potency is not estimated to be affected by any presently circulating SARS-Cov-2 variant of concern or variant of interest.

This potency was established in the laboratory at the Rega institute of KU Leuven, Belgium with data demonstrating XVR011’s robust in vitro neutralisation activity against the Delta, Alpha, Beta and Gamma variants.

Last month, ExeVir Bio dosed the first participants in the Phase I trial of its llama-derived antibody, XVR011 (VHH72-Fc), for Covid-19 prevention and treatment.

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