Leronlimab is a novel humanized monoclonal antibody that is a CCR5 antagonist with the potential for multiple therapeutic indications, including a therapy for treating Covid-19 Patients. Leronlimab targets and binds to the CCR5 receptor and, for example, inhibits RANTES (CCL5 found in high levels in severe to critical Covid-19 patients) from binding to CCR5 and thereby preventing the formation of chemokines and cytokines that cause the “cytokine storm” which invades the lungs causing severe inflammation and reductions in blood-oxygen levels.
Cytodyn Inc., located in Vancouver, Washington, is a late-stage biotechnology company developing leronlimab.
CytoDyn’s Phase 2b/3 trial to evaluate the efficacy and safety of leronlimab for patients with severe-to-critical COVID-19 indications is a two-arm, randomized, double blind, placebo controlled, adaptive design multicenter study. Patients are randomized to receive weekly doses of 700 mg leronlimab, or placebo. Leronlimab and placebo are administered via subcutaneous injection. The study has three phases: Screening Period, Treatment Period, and Follow-Up Period. The primary outcome measured in this study is: all-cause mortality at Day 28. Secondary outcomes measured are: (1) all-cause mortality at Day 14, (2) change in clinical status of subject at Day 14, (3) change in clinical status of subject at Day 28, and (4) change from baseline in Sequential Organ Failure Assessment (SOFA) score at Day 14.
On October 20, 2020, Cytodyn announced recommendations from the independent Data Safety Monitoring Committee (DSMC) following its review of the interim analysis of the Company’s Phase 2b/3 registrational trial in patients with severe-to-critical COVID-19. The interim analysis was performed on data from the first 195 (50%) of 390 planned patients. The DSMC recommended that the trial continue without modification to achieve the primary endpoint and requests another interim analysis when enrollment reaches 75% level (or 293 patients) to review patient mortality and other clinical outcome data between the two study arms (leronlimab vs. placebo).