CytoDyn Inc (OTCQB:CYDY) plans to submit the topline results of its CD12 Phase 3 clinical trial of Vyrologix (leronlimab-PRO 140) for severe to critically ill COVID-19 patients to regulatory agencies, including those in India and the Philippines.
Patients in the CD12 trial were administered two doses of leronlimab, the first on day zero and another on day seven. Results showed that over that initial span, critically ill patients receiving leronlimab on day zero experienced a mortality rate 78% lower than patients receiving placebo. Further, patients receiving the second dose of leronlimab on day seven achieved a peak benefit of 82% lower mortality, the company said.
That said, the effects diminished from day 14 to day 21 and from day 21 to day 28, as the mortality rate decreased to 50% and 31%, respectively, which the company attributed to patients not receiving leronlimab after day 7.
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“We are very thankful for the opportunity to be able to conduct two very crucial clinical trials in Brazil for severe and critically ill COVID-19 patients, which we believe could result in a statistically significant p-value of our primary endpoint leading the way to a potential approval,” CEO Nader Pourhassan said in a statement. “Although we did not meet our primary endpoint in our CD12 clinical trial in the mITT population, we were still very pleased that we did meet almost all of our secondary endpoints in the critically ill subpopulation of COVID-19 patients.”
Pourhassan remains confident that leronlimab can earn regulatory approval in 2021, given its secondary success.
“To the best of our knowledge, we are unaware of another drug or therapeutic, which has reported results in the critically ill population, in a randomized controlled trial, remotely close to what we reported for the CD12 trial,” Pourhassan said. “We are very excited for the opportunity to receive our first approval in multiple countries in great need of leronlimab. We are very confident this approval will happen this year.”
In COVID-19 patients, leronlimab works by mitigating what is known as the cytokine storm, a hyperactive immune response that can cause inflammation, fatigue, and in severe cases, organ failure.
Aside from COVID-19, the US Food & Drug Administration (FDA) has granted Fast Track designation to CytoDyn for two potential indications of leronlimab for critical illnesses. The first is a combination therapy with HAART for HIV-infected patients and the second is for metastatic triple-negative breast cancer.
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