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Investigational HIV/Breast Cancer Drug Promising for COVID-19 Treatment

The FDA has granted Emergency Investigational New Drug Status to a medication developed to treat HIV and breast cancer for use with novel coronavirus patients. The drug, leronlimab, has shown promise for mitigating cytokine storms in severe COVID-19 cases and now will be tested in clinical trials. Here is more information.

VANCOUVER, WA – A drug that previously was granted Fast Track Designation by the Food and Drug Administration for treatment of HIV and breast cancer now has gained Emergency Investigational New Drug status after some promising results with COVID-19 patients.

The drug from CytoDyn Inc, leronlimab, is an investigational CCR5 antagonist in development for the treatment of HIV infection, metastatic triple-negative breast cancer, and severe respiratory complications associated with COVID-19.

With 10 patients seriously ill with COVID-19 at a New York medical center receiving the drug under the EIND, eight showed improvement in immunologic biomarkers, including cytokines, interleukin (IL)-6, and a trend toward the normalization of the CD4/CD8 ratio three days post-treatment, according to the company. Leronlimab is administered by injection once per week in patients with COVID-19.

“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,” said Bruce Patterson, MD, CEO and founder of IncellDx, a diagnostic partner, and an advisor to CytoDyn. “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,”

A randomized, double-blind, placebo-controlled phase II study of leronlimab as treatment of COVID-19 is anticipated to soon include 75 patients from up to 10 treatment centers in the United States. In addition, CytoDyn has also filed for the initiation of a phase II/III trial for the treatment of severely ill patients with COVID-19; that double-blind trial is expected to enroll 342 patients and randomize them in a 2:1 ratio. Defined as the primary end point is 14-day mortality rate.

The drug is not designed to kill the disease but to block pro-inflammatory cytokines leading to cytokine storms in COVID-19 patients while enhancing immune response. Leronlimab is targeted as a therapy for patients who experience respiratory complications as a result of contracting SARS-CoV-2

“We are extremely pleased for the coronavirus patients under the care of the treating medical team and that the FDA is so responsive to advance our Phase 2 clinical trial,” added Nader Pourhassan, PhD, President and Chief Executive Officer of CytoDyn. “I am very hopeful that leronlimab can help to reduce the rate of mortality among COVID-19 patients with severe symptoms of ARDS and to assist our government to fight this battle.”

Earlier clinical trials of leronlimab in the treatment of HIV found that side effects might include diarrhea, headache, swollen lymph nodes, high blood pressure, and injection site reactions.