BOOOOM! Leronlimab Decreased Mortality at 14 Days

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Leronlimab Decreased Mortality at 14 Days by 82% With Statistically Significant P-Value of 0.0233 Amongst Critically Ill COVID-19 Patients

Download as PDFMarch 30, 2021 6:00am EDT
Clinical outcome improvement (based on ordinal scale) with leronlimab at day 14 was 400% better than placebo arm with p-value of 0.021

VANCOUVER, Washington, March 30, 2021 (GLOBE NEWSWIRE) -- CytoDyn Inc. (OTC.QB: CYDY), ("CytoDyn" or the "Company", a late-stage biotechnology company developing Vyrologix™ (leronlimab-PRO 140), a CCR5 antagonist with the potential for multiple therapeutic indications, is pleased to announce further results from its CD12 trial of severe-to-critically ill patients with COVID-19.

Upon further statistical analysis of the critically ill population (hospitalized patients receiving invasive mechanical ventilation (IMV) or ECMO), it was revealed that when leronlimab was added to standard of care (“SoC”), leronlimab decreased mortality at 14 days by 82% (p=.0233, N=62). Patients who received leronlimab were over five times more likely to be alive at day 14 than those who received SoC only.

Furthermore, leronlimab administration was associated with a 400% improvement in the ranking on the 7-point ordinal scale at 14 days when given in conjunction with SoC (p=.021, N=62) in the critically ill population, which provides direct evidence of tangible patient improvement.

The Company believes this data provides an opportunity to expound upon the advice and expertise of our Key Opinion Leaders to optimize the dosing of leronlimab for further clinical benefit.

This analysis builds upon the previously released information from the Company’s mITT analysis of CD12 showing:

A clear benefit when leronlimab was used in addition to “commonly used COVID-19 treatments,” in the primary endpoint of all-cause mortality at day 28 with an absolute risk reduction of death of 6.5% and a relative risk reduction of death of 28.1% (N=309, p=.0319).
A clear benefit when leronlimab was used in combination with dexamethasone, in the primary endpoint of all-cause mortality at day 28 with an absolute risk reduction of death of 5.7% and a relative risk reduction of 26.0% (N=233, p=.0552).
Length in hospital stay decreased by 5.5 days in the critically ill population (N=62, p=.005).
A clear trend toward mortality benefit at day 28 with an absolute risk reduction of death of 20.9% and a relative risk reduction of death of 73% when leronlimab was used in addition to “commonly used COVID-19 treatments” in the critically ill population with an age ≤ 65 years old.
A clear trend toward mortality benefit at day 28 with an absolute risk reduction of death of 16.3% and a relative risk reduction of death of 73.5% when leronlimab was used in addition to dexamethasone in the critically ill population ≤ 65 years old.
Nader Pourhassan, Ph.D., President and Chief Executive Officer of CytoDyn, commented, “We will expediently submit an update with the above 14-day benefit to the U.S. FDA, Health Canada, and MHRA and will work closely with regulators in other countries. The Company believes this new information bolsters the case for immediate use of leronlimab for critically ill patients. Furthermore, we believe these results suggest that to see maximum effect of leronlimab at day 28, we must use three to four doses of leronlimab and not just two doses, as was the case with CD12 (day zero and day 7 only).”

The Company will provide further updates next week in an investment community webcast.

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