CYDY - CytoDyn files new protocol with FDA for 4 doses of leronlimab for critical COVID-19

After several weeks of discussions with the FDA and analysis of CD12 trial data, CytoDyn (CYDY) has filed a new protocol for leronlimab to extend treatment to four weeks.The Company believes four weeks of leronlimab treatment to be sufficient to calm the cytokine storm and to have a positive effect on survival rate at four weeks and potentially eight weeks.In recent analysis, leronlimab reduced mortality rate by 82% at 14 days with 400% improvement in clinical outcome and much better discharge rate.These results were achieved with just two doses of leronlimab, one dose at day 0 and a second dose at day 7.The half-life of leronlimab is 10 days and with only 2 doses, 24% survival benefit was observed at 28 days in critically ill COVID-19 patients.Based on these results, CYDY believes an increased dosage regimen will result in an equal or greater mortality benefit.

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CytoDyn files new protocol with FDA for 4 doses of leronlimab for critical COVID-19