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

CytoDyn Inc (OTCQB:CYDY) announced additional results Tuesday from its CD12 trial of Vyrologix (leronlimab-PRO 140) in severe-to-critical coronavirus (COVID-19), revealing that the drug decreases mortality by 82% after two weeks of treatment among critical patients.  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 said.  Additionally, leronlimab administration was associated with a 400% improvement in ranking on the 7-point ordinal scale used to measure clinical status when used in conjunction with SoC in the critically ill population, which the company said provides direct evidence of tangible patient improvement.  READ: CytoDyn says the Philippines FDA approves the use of leronlimab to treat a COVID-19 patient This analysis builds upon the previously released information from the company’s mITT analysis of the CD12 trial, which showed a clear benefit when leronlimab was used in addition to “commonly used COVID-19 treatments,” in the primary endpoint of all-cause mortality after four weeks. Absolute risk reduction of death was 6.5% and relative risk reduction of death was 28.1%. The analysis also found a clear benefit when leronlimab was used in combination with dexamethasone, with an absolute risk reduction of death of 5.7% and a relative risk reduction of 26.0% after four weeks. Length in hospital stay decreased by 5.5 days in the critically ill population. Narrowing the focus even farther, there was 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 at or above the age of 65. With dexamethasone, leronlimab led to an absolute risk reduction of death of 16.3% and a relative risk reduction of death of 73.5% in the same subset.  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 US FDA, Health Canada, and MHRA [in the UK] and will work closely with regulators in other countries,” CEO Nader Pourhassan said in a statement.  “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).” Contact Andrew Kessel at andrew.kessel@proactiveinvestors.com Follow him on Twitter @andrew_kessel