CytoDyn files new protocol with FDA for four doses of leronlimab for critically ill coronavirus patients

CytoDyn Inc (OTCQB:CYDY), a biotechnology company developing its flagship drug Vyrologix (leronlimab-PRO 140) for multiple indications, revealed Thursday that after several weeks of discussions with the US Food and Drug Administration (FDA), and analysis of CD12 trial data, it has filed a new protocol to extend treatment to four weeks. 

This decision comes after Vancouver-based CytoDyn shared positive data on Tuesday from its CD12 trial of leronlimab in severe-to-critical coronavirus (COVID-19), revealing that the drug decreases mortality by 82% after two weeks of treatment among critical patients.  

CytoDyn said it will initiate patient enrollment in multiple countries, including Brazil, where there are over 20,000 COVID-19 patients in ICU.  CytoDyn believes four weeks of leronlimab treatment to be sufficient to calm the so-called cytokine storm and to have a positive effect on survival rate at four weeks and potentially eight weeks. 

READ: CytoDyn’s leronlimab decreases mortality by 82% among critically ill coronavirus patients after two weeks in CD12 trial

In a statement, CytoDyn CEO Nader Pourhassan said: “As recently reported, our further analysis of the CD12 trial data demonstrated a statistically significant 82% reduction in mortality at 14 days for critically ill COVID-19 patients with 400% improvement in clinical outcome based on ordinal scale with discharge rate much better in leronlimab with p-value statistically significant.”

“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, it is impressive we observed a 24% survival benefit at 28 days in critically ill COVID-19 patients, which we believe is as good or better than any reported results achieved so far with any other product for the critically ill population of COVID-19. Based on these results, we believe an increased dosage regimen will result in an equal or greater mortality benefit.”

Critically ill patients are defined as those receiving invasive mechanical ventilation (IMV). The addition of leronlimab to a current standard of care (SoC) meant that patients, who received the drug were more than five times more likely to be alive at day 14 than those who received SoC only. The company saw 82% survival results over placebo after two weeks of leronlimab treatment, with “statistically significant p-value of 0.0233.”

Contact the author Uttara Choudhury at [email protected]

Follow her on Twitter: @UttaraProactive

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