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December 22, 2021updated 07 Jan 2022 7:23am

FDA provides positive response to begin CytoDyn’s Covid-19 antibody trial

The Phase III trial will assess the safety of leronlimab plus SOC in critically ill Covid-19 patients with pneumonia.

The US Food and Drug Administration (FDA) has provided a positive response to CytoDyn for commencing a Phase III clinical trial of its antibody, leronlimab for Covid-19.

An experimental humanised IgG4 monoclonal antibody, leronlimab attaches to chemokine receptor 5 (CCR5).

A cellular receptor, CCR5 is vital in HIV infection, tumour metastases and various other ailments.

The double-blind, randomised, placebo-controlled trial will analyse the efficacy and safety of leronlimab plus standard of care (SOC) treatment for critically ill Covid-19 patients with pneumonia.

It will enrol subjects who require invasive mechanical ventilation or extracorporeal membrane oxygenation.

Trial subjects will be categorised in a 1:1 ratio and receive up to four intravenous doses of 700mg leronlimab plus SOC or placebo plus SOC.

Earlier this month, the company filed the Phase III trial protocol with the FDA.

CytoDyn president and CEO Nader Pourhassan said: “As Covid-19 cases continue to surge in the US, we are grateful for the opportunity to move forward with the Phase III trial of leronlimab as a treatment option for critically ill Covid-19 patients.

“There continues to be an immense need for therapeutic options to support this population, and we are optimistic that Phase III will show promising results.”

According to subgroup analyses data from a Phase III CD12 trial that enrolled 62 severe-to-critically ill subjects with Covid-19, two doses of leronlimab showed a survival benefit of 82% at day 14 versus SOC in combination with placebo.

In October this year, the company treated the first subject in the Phase III CD16 trial of leronlimab in critically ill Covid-19 patients in Brazil.

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