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CytoDyn has started dosing patients in a Phase IIb/III clinical trial of leronlimab for the treatment of severe and critical Covid-19 indications.
The double-blinded trial, which recently secured US Food and Drug Administration (FDA) clearance, is set to enrol approximately 390 patients.
Participants will receive leronlimab for two weeks. The primary endpoint of the study is the mortality rate at 28 days, while a secondary endpoint is the mortality rate at 14 days.
Interim analysis will be conducted on the trial results from 50 patients.
CytoDyn president and CEO Nader Pourhassan said: “We continue to support the medical community’s increasing demand for leronlimab and are pleased for the severely ill patients now enrolling in our Phase IIb/III trial.
“We are hopeful that they will experience like therapeutic benefits demonstrated by many similar patients treated under EINDs.”
The company is also conducting a Phase IIb trial of the drug to treat mild-to-moderate Covid-19 coronavirus infection.
This study will evaluate the safety and efficacy of leronlimab given as a weekly subcutaneous injection. The primary outcome measure is clinical improvement based on a change in total symptom score.
Both Covid-19 trials fall under the same investigational new drug application submitted to the FDA.
The drug has also been given to approximately 30 patients as part of emergency investigational new drug (EIND) authorisations.
Leronlimab is an investigational humanised IgG4 monoclonal antibody designed to block CCR5, a cellular receptor involved in HIV infection, tumour metastases, and other diseases.
The drug obtained FDA fast track designation to be used as a combination therapy with HAART for HIV patients and to treat metastatic triple-negative breast cancer. It has completed nine trials in a total of more than 800 people.