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Biotechnology firm CytoDyn has submitted a second clinical trial protocol to the US Food and Drug Administration (FDA) for the use of leronlimab to treat severe illness caused by Covid-19 infection.
The second trial will fall under the investigational new drug filing approved by the FDA to perform a Phase II study of the drug in novel coronavirus patients with mild-to-moderate symptoms.
Under an emergency IND, leronlimab was given to ten severely ill patients at a medical centre in New York City, US.
Leronlimab is an investigational humanised IgG4 monoclonal antibody designed to block CCR5, a cellular receptor involved in HIV infection, tumour metastases, and other diseases.
CytoDyn president and CEO Nader Pourhassan said: “Once again, the FDA continues to be very supportive of everyone’s efforts to increase access to leronlimab in order to assess its therapeutic benefits for a broader range of Covid-19 patients.
“With a study in China indicating the mortality rate among Covid-19 patients requiring mechanical ventilator at more than 85%, the world desperately needs a therapy that can help this patient population.”
The company intends to recruit mild-to-moderately ill, as well as severely ill Covid-19 patients under the same IND approved by the US regulatory agency.
CytoDyn designed the new protocol as a double-blinded trial for around 342 severely ill patients. Participants will receive leronlimab for two weeks.
The primary endpoint of the second trial is mortality rate at 14 days.
The first trial will assess the safety and efficacy of leronlimab administered as a weekly subcutaneous injection. The primary outcome measure is clinical improvement based on a change in total symptom score.
Leronlimab obtained the FDA fast track designation to be used as a combination therapy with HAART for HIV patients and to treat metastatic triple-negative breast cancer.