CytoDyn Inc has announced that Brazil’s regulatory authority Agência Nacional de Vigilância Sanitária (ANVISA) has approved its previously submitted clinical trial protocol for its flagship drug candidate leronlimab to start patient enrollment in the CD17 trial for severe coronavirus (COVID-19) patients.
The Vancouver, Washington-based late-stage biotechnology company said the academic research organization (ARO) Albert Einstein Israelite Hospital (AEIH), in Brazil will conduct the trial.
The trial is intended to provide ANVISA with the requisite data to consider advancing the availability of leronlimab to Brazilians infected with COVID-19, said the company. The Phase 3 trial will be conducted in up to 35 clinical sites with 612 patients who are hospitalized and in need of oxygenation support.
READ: CytoDyn advances to Phase 2 trial with leronlimab for mTNBC metastatic breast cancer treatment
“The trial aims to prevent the disease from evolving into a more severe case, requiring invasive mechanical ventilation,” said the company. In addition, ANVISA is reviewing another protocol submitted for a second clinical trial for 316 critically ill COVID-19 patients.
The Phase 3 trial for severe COVID-19 patients has built-in an interim analysis to be conducted after 245, or 40% of the patients have been enrolled and the last-enrolled patient has completed 28 days of treatment with leronlimab.
As of July this year, Brazil had the highest number of confirmed cases of COVID-19 in Latin America and ranked third highest in the world.
In a statement, CytoDyn chief operating officer and head of Clinical Development, Dr Chris Recknor commented: “The CD17 trial was designed in collaboration with our partners at Einstein ARO and BIOMM to have an adequately powered interim analysis after 40% of the patients have been enrolled and completed 28 days of treatment with leronlimab.”
“Given that average weekly cases currently are over 35,000 we anticipate that the results of the interim analysis may be available in the next three to four months using the endpoints we refined from CD12,” he added.
Meanwhile, CytoDyn CEO Nader Pourhassan said the company is “very grateful” to ANVISA and for “the hard work of all involved including ARO, BIOMM, and CytoDyn.”
“It has been a challenging road, but we are pleased to be in the position to potentially have results from two COVID-19 trials in Brazil and potentially one COVID-19 long hauler trial in the US,” added Pourhassan. “We truly believe our CD12 data has been crucial for us in designing these new trials in Brazil to give leronlimab the best chance at success.”
Aside from COVID-19, the US Food & Drug Administration (FDA) has granted Fast Track designation to CytoDyn for two potential indications of leronlimab for critical illnesses. The first is a combination therapy with HAART for HIV-infected patients and the second is for metastatic triple-negative breast cancer.
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