CytoDyn Inc (OTCQB:CYDY), which is developing Vyrologix (leronlimab-PRO 140) for multiple indications, has said that its Brazilian distribution partner Biomm SA (BVMF:BIOM3) plans to submit an authorization request to the Brazilian National Health Surveillance Agency (ANVISA), to conduct two Phase 3 clinical trials of leronlimab in Brazil for coronavirus (COVID-19) patients.
The Vancouver, Washington-based late-stage biotech said the request will be submitted to ANVISA “in the next few days” to conduct two Phase 3 trials for a batch of critically ill COVID-19 patients, and another severely ill population. Once approved by ANVISA, the Phase 3 trials will be conducted by the Albert Einstein Israelite Hospital, an academic research organization in Brazil.
The trials in Brazil are intended to provide ANVISA with the requisite data to consider advancing the availability of leronlimab to thousands of Brazilians infected with COVID-19. These two Phase 3 trials will be conducted in up to 45 clinical sites, said the company.
“The critically ill protocol is for 306 patients while the severe protocol is for 594 patients, and interim analysis for both populations will be conducted when enrollment reaches about 40% of the total number for each trial,” said the company.
In a statement, CytoDyn CEO Nader Pourhassan said: “We continue to be grateful to Mr Marchezini and his team at Biomm for expediting our efforts to advance the availability of leronlimab for all patients who might benefit from this immune modulator product.”
“We look forward to continuing to identify partnerships in other countries experiencing a surge in COVID-19 cases similar to Brazil, the Philippines and India where leronlimab could potentially save lives.”
Biomm is principally engaged in the development and licensing of technology for the production of human insulin and other recombinant proteins. The firm’s plant in Nova Lima has the capacity to produce 20 million doses of insulin a year.
In COVID-19 patients, leronlimab works by mitigating what is known as the cytokine storm, a hyperactive immune response that can cause inflammation, fatigue, and in severe cases, organ failure.
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.
Contact the author Uttara Choudhury at firstname.lastname@example.org
Follow her on Twitter: @UttaraProactive