CytoDyn’s COVID-19 treatment shows positive results in Phase III trial

pharmafile | March 9, 2021 | News story | Manufacturing and Production cytodyn, phase 3 trial, vyrologix 

Biotechnology company CytoDyn has shown positive results in its Phase III CD12 trial of Vyrologix, its treatment for COVID-19 patients with severe or critical symptoms as a result of the illness.

The study showed a 24% reduction in mortality in patients given Vyrologix, versus those given a placebo. The treatment was also shown to reduce hospital stay by six days in those who received it with standard care.

The trial’s data has been reported to the FDA, the MHRA, and Health Canada, with CytoDyn in discussions with each to determine the best path forward for approval of Vyrologix, known generically as leronlimab, for treatment of COVID-19 in the critically ill population.

Studies are ongoing, with CytoDyn also enrolling a further 45 patients to gather further data, as only 62 of the 384 patients in the initial study were classed as critically ill.

Leronlimab has been the subject of nine clinical trials previously, each of which demonstrating that the treatment could significantly reduce or control HIV viral load in humans.

COVID-19 has so far caused around 2.6 million deaths worldwide, despite the global vaccination effort that is now well underway to limit its future impact.

Nader Pourhassan PhD, President and CEO of CytoDyn, said: “Today, there are no approved drugs to effectively address the unmet medical need for critically ill COVID-19 patients. Our CD12 study demonstrates leronlimab is particularly effective in treating this patient population. We believe these results are the best results ever achieved for this population in a Phase III clinical trial. 

“A recently approved IL-6 blocker, used to treat severe to critical hospitalised COVID-19 patients requiring mechanical ventilation, reduced mortality by 2% compared to the placebo group. In contrast, leronlimab demonstrated a reduction of 24% in mortality compared to the standard of care treated group, which is 12 times better in reducing all-cause mortality for critically ill COVID-19 patients.”

Jack Goddard

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