Cytodyn Inc (CYDY)

[Monroe1]

Albert Einstein Israelite Hospital in Sao Paulo Brazil to Lead two Large Brazilian Phase 3 Trials Investigating Leronlimab for COVID-19

[This enrollment will go much faster. They are well experienced in conducting trials.]

The investigational product known as leronlimab (Vyrologix or PRO 140), a CCR5 antagonist, has evidenced the potential for multiple therapeutic indications, including COVID-19. Recently, the commercial sponsor behind the therapy, CytoDyn Inc. (OTC.QB: CYDY), inked a deal with an Academic Research Organization (ARO) called Albert Einstein Israelite Hospital (AEIH) in São Paulo, Brazil, for two COVID-19 clinical trials to be conducted in the South American nation. These two Phase 3 clinical trials are designed to provide ANVISA, the Brazilian regulatory authority, with the requisite data to consider advancing the availability of leronlimab to thousands of Brazilians infected with COVID-19. With AEIH in the lead, the studies will involve up to 45 trial sites in Brazil. These large studies represent a fundamental milestone for the biotech sponsor; leronlimab’s challenge in meeting primary endpoints in its U.S. study delayed any emergency use authorization (EUA) as more data is now necessary. Will the drug deliver the results in Brazil, which is one of the world’s worst COVID-19 hotspots?