Leronlimab (PRO 140) is a CCR5 antagonist with the potential for multiple therapeutic indications, such as HIV, cancer, and unwelcome immune reactions .
The cytokine storm observed in patients with COVID-19 promotes the development of acute respiratory distress syndrome (ARDS). A distinctive feature of ARDS is the accumulation of neutrophils within the lungs. Leronlimab (PRO 140) can potentially inhibit the migration of regulatory T cells into the damaged tissue, which can modulate the innate immune response against pathogens and, most importantly, mitigate the migration of macrophages and the release of pro-inflammatory cytokines into the lungs. Following compassionate care treatment of critically ill COVID-19 patients with the CCR5-blocking antibody leronlimab, complete CCR5 receptor occupancy on macrophage and T cells, rapid reduction of plasma IL-6, restoration of the CD4/CD8 ratio, and a significant decrease in SARS-CoV-2 plasma viremia were observed .
CytoDyn Inc. has initiated a Phase 2, two-arm, randomized, double-blind, placebo-controlled multicenter study to evaluate the safety and efficacy of leronlimab (PRO 140) in 75 patients with mild-to-moderate symptoms of respiratory illness caused by coronavirus 2019 infection. The estimated primary completion date is December 4, 2020, while full results are expected in April 2021 .
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- Disruption of the CCL5/RANTES-CCR5 Pathway Restores Immune Homeostasis and Reduces Plasma Viral Load in Critical COVID-19 (preprint)