Leronlimab (PRO 140), demonstrated improvement in total clinical symptom score at day 3 in patients with mild-to-moderate symptoms from coronavirus disease 2019 (COVID-19). The humanized igG4 monoclonal antibody also induced a statistically significant improvement in the National Early Warning Score 2 scale, a key secondary end point of a phase 2 CD10 clinical trial, CytoDyn, Inc announced in a press release.
“The results demonstrate that CCR5 blockade by leronlimab given as a weekly subcutaneous injection in mild-to-moderate COVID-19 patients is reasonably safe and associated with rapid improvement in viral symptoms with fewer adverse events than when compared to placebo,” lead principal investigator Harish Seethamraju, MD, of the Montefiore Medical Center in New York, said in a statement.
CD10 is a randomized, double-blind, placebo-controlled study that is evaluating the efficacy and safety of leronlimab in patients with mild-to-moderate symptoms from COVID-19. Additional key secondary end points of the study include time to clinical resolution, change from baseline in oxygen saturation, and change from baseline in health status on a 7-category scale.
In terms of the National Early Warning Score, an objective scale for identifying patients who are at risk for rapid health deterioration and in need of critical care, the likeliness that patients in the leronlimab arm would have a beneficial improvement in scores was 50% versus 20% for patients in the placebo arm (P = .0223), at the end of treatment, or at day 14.
Among patients who received leronlimab in the study, 90% had an improvement in total clinical symptom score versus 71% in the placebo group. This improvement was observed in patients who had a baseline total clinical symptom score of ≥4. An even greater treatment impact from leronlimab versus placebo was seen in subgroups of patients who had more baseline symptoms than others.