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CytoDyn has submitted an investigational new drug (IND) application to the US Food and Drug Administration (FDA) to start a clinical trial with leronlimab (PRO 140) as a therapy for patients who experience respiratory complications as a result of the new coronavirus (Covid-19) infection.
The study aims to assess the safety and efficacy of leronlimab administered as weekly subcutaneous injection in subjects with coronavirus.
Leronlimab is an investigational humanised IgG4 mAb. It is claimed to block CCR5, a cellular receptor vital in HIV infection, tumour metastases, and other diseases.
CytoDyn noted that the study will have screening, treatment, and follow-up periods.
The primary outcome measures of this single-arm, open-label, multi-centre study are cited as clinical improvement based on a change in total symptom score.
The symptoms are graded on a scale of zero to three and include fever, myalgia, dyspnea and cough.
CytoDyn president and CEO Nader Pourhassan said: “Our scientists believe that our data in cancer patients indicated that leronlimab’s role in blocking Tregs and macrophages demonstrates that leronlimab modulates the inflammatory response to more effectively provide effector function.
“With leronlimab’s fast-track designation from the FDA for the treatment of HIV and mTNBC (triple-negative breast cancer), we are expediting the initiation of this trial to address the rapid spread of this disease and are eager to test this proof of concept in clinical trials as a potential treatment for coronavirus.”
The company has secured ‘fast-track’ designation from the FDA for two potential indications of leronlimab. The first as a combination therapy with HAART for HIV-infected patients and the second for mTNBC.
Nine clinical trials on the drug have been conducted so far.
Meanwhile, the Covid-19 death toll has crossed 3,800 globally. The number of cases and deaths across the world continues to increase.