Leronlimab Shows Statistically Significant Improvement in Efficacy Outcome in Mild-to-Moderate COVID-19

August 12, 2020

Leronlimab, demonstrated improvement in total clinical symptom score at day 3 in patients with mild-to-moderate symptoms from coronavirus disease 2019.

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.

In an analysis of the per-protocol population, a similar statistically significant outcome was observed at day 3 (P <.03) and at day 14 (P <.02).

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.

The safety analysis showed that adverse events (AEs) and serious AEs occurred less often in the leronlimab arm compared with the placebo arm. Those in the placebo arm were twice as likely to experience an AE or serious AE.

Expanding upon the safety findings, Jacob P. Lalezari, MD, senior science advisor to CytoDyn, stated, "Treatment with leronlimab demonstrated reductions in both serious adverse events, as well as predictors of pulmonary collapse in patients with mild-to-moderate COVID-19. We initiated the study hoping to reduce flu-like symptoms, such as fever, cough, and muscle aches. In the end, the use of leronlimab was not only correlated with improved symptom scores in patients with measurable symptoms at baseline but also provided significant and consequential benefits on far more serious end points. Demonstrating these efficacy signals in a population with mostly mild illness at study entry bodes well for leronlimab’s activity in patients with more severe illness.”

The CD10 trial is currently ongoing but has already reached its target enrollment of 86 patients. Eligible patients were those aged 18 years or older with mild or moderate COVID-19-related illness and a clinically normal resting 12-lead echocardiogram at the time of screening. Individuals with signs of acute respiratory distress, history of severe chronic respiratory disease, liver disease, kidney disease, and other conditions that may interfere with leronlimab treatment were excluded from the study.

In addition to the CD10 trial, leronlimab is also under investigation in a phase 3 clinical trial as treatment of severe-to-critically-ill patients with COVID-19. The agent is also being investigated in the treatment of patients with metastatic triple-negative breast cancer.

Reference:

CytoDyn announces clinically significant top-line results from its phase 2 trial in mild-to-moderate covid-19 patients. News release. CytoDyn, Inc. August 11, 2020. Accessed August 12, 2020. https://bit.ly/2E0N8ri