The FDA has provided clearance for the initiation of, and immediate enrollment for, a new phase II trial to explore the use of the investigational oncologic agent leronlimab in treating patients with coronavirus disease 2019 (COVID-19) who experience mild to moderate respiratory complications.1

CytoDyn, the developer of leronlimab, had filed an Investigational New Drug (IND) application and protocol with the FDA at the beginning of March for the initiation of the trial.2Two weeks later, the FDA cleared an emergency IND to allow for the treatment of 2 patients with COVID-19 in New York with leronlimab therapy.3Already a total of 10 severely ill patients have been treated with the CCR5 antagonist.

CytoDyn, developer of leronlimab announced in a press release that after 3 days of treatment with leronlimab, 8 patients with COVID-19 who are seriously ill have shown an improvement in several important immunologic biomarkers, including cytokines, interleukin (IL)-6, and a trend toward the normalization of the CD4/CD8 ratio.5

“We are very pleased with our most recent laboratory data for patients treated with leronlimab for COVID-19 infection. We continue to see increases in the profoundly decreased CD8 T-lymphocyte percentages by Day 3, normalization of CD4/CD8 ratios, and resolving cytokine production including reduced IL-6 correlating with patient improvement. The current data suggests a trend toward the restoration of immune function and mitigation of the cytokine storm. This is consistent with prior laboratory results in the first four patients treated for COVID-19 with leronlimab,” Bruce Patterson, MD, CEO and founder of IncellDx, a partner of CytoDyn’s, said in a statement.5

The randomized, double-blind, placebo-controlled phase II study of leronlimab as treatment of COVID-19 is expected to include 75 patients from up to 10 treatment centers in the United States. CytoDyn has also filed for the initiation of a phase II/III trial for the treatment of severely ill patients with COVID-19. This double-blind trial is expected to enroll 342 patients and randomize them in a 2:1 ratio. The primary end point of this trial is the mortality rate at 14 days.6

COVID-19 or SARS-CoV-2 was first identified as a respiratory illness that broke out in Wuhan, China. However, the exact origin of the novel disease is uncertain.4Currently, there are very limited treatment options for patients with COVID-19. Although leronlimab does not kill the disease, it is a CCR5 antagonist that block pro-inflammatory cytokines to prevents cytokine storms that can occur with COVID-19.3

Leronlimab is administered by injection once per week in patients with COVID-19. The efficacy and safety of the drug had been shown in prior clinical trials, predominantly as treatment of patients with cancer,including metastatic triple-negative breast cancer. However, leronlimab is also under investigation for the treatment of patients with human immunodeficiency virus.

“We remain encouraged and hopeful that leronlimab will help patients from this devastating and relentless disease. We will aggressively pursue treatment for COVID-19 patients, and to explore leronlimab’s role in helping to alleviate the impending burden of supply chain and institutional capacity issues, said Nader Pourhassan, PhD, president, and chief executive officer, CytoDyn, in a statement.3

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