CytoDyn Inc (OTCQB:CYDY) announced Monday that study results have been unblinded from the CD12 trial of its drug Vyrologix (leronlimab or PRO-140) in coronavirus (COVID-19) patients, and the company will reveal them once discussions with regulators are complete.
The Phase 2b/3 trial enrolled 394 severe-to-critical COVID-19 patients, who were randomized to receive either 700 milligrams of Vyrologix or a placebo once a week by injection.
The primary outcome measured is linked to mortality at day 28, the company has said previously. There are secondary outcomes measured by mortality at day 14, change in clinical status at day 14, change in clinical status of the subject at day 28, and change from baseline in Sequential Organ Failure Assessment (SOFA) score at day 14.
READ: CytoDyn partners with Chiral Pharma to register Vyrologix in the Philippines
“We are eager to reach [a] conclusion in our discussions with all the regulatory agencies for the path going forward and will release the details of our data and the results of our discussions with regulatory agencies in the coming weeks,” CEO Nader Pourhassan said in a statement.
CytoDyn previously completed a Phase 2 clinical trial for COVID-19, a double-blinded, clinical trial for mild-to-moderate patients in the US, which produced statistically significant results using the National Early Warning Score (NEWS2) degree of illness metric.
Aside from COVID-19 , the US Food and 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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