CytoDyn strikes agreement with AEIH in Brazil to run two coronavirus trials using its flagship drug leronlimab

CytoDyn Inc (OTCQB:CYDY) announced that it has struck an agreement to partner with the Academic Research Organization (ARO) - Albert Einstein Israelite Hospital (AEIH), in São Paulo, Brazil to run two trials with its flagship drug leronlimab (Vyrologix or PRO 140) on a small batch of critically ill coronavirus (COVID-19) patients, and a larger severely ill population. The Vancouver, Washington-based late-stage biotechnology company said the COVID-19 trials in Brazil are intended to provide the Brazilian regulatory authority, ANVISA, with “the requisite data” to consider making leronlimab available 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. In a statement, CytoDyn chief operating officer Chris Recknor said: “We are pleased to partner with one of the best hospitals in Latin America, the Albert Einstein Israelite Hospital and their affiliated academic research organization network. ARO has conducted multiple large-scale COVID trials for many pharmaceutical companies.” READ: CytoDyn submits manufacturing section of interim order application for leronlimab as coronavirus treatment to Health Canada “CytoDyn is utilizing their extensive experience to develop and conduct our CD16 and CD17 COVID-19 trials. With approximately 1,500 patients in total for both trials, we anticipate having adequate power in each trial to achieve a significant p-value for our endpoints and will be performing an interim analysis after 40% of the critically ill patients are enrolled,” he added. Recknor noted that in Brazil, the P1 COVID variant is fueling a second wave worse than the initial outbreak. “In April, more than 78,000 people lost their lives from COVID and ICU capacity in 15 of Brazil’s 26 states, is at or above 90% full,” he pointed out. “Vyrologix is variant agnostic. We expect an interim analysis will be conducted in October-November of this year. We look forward to accelerating these trials for the benefit of the Brazilian people.” Meanwhile, CytoDyn CEO Nader Pourhassan said the agreement represents the “relentless effort” of the CytoDyn team. “Dr Christopher Recknor and many other CytoDyn team members did a fantastic job getting this protocol to its final form. We also thank the BIOMM team of Brazil for presenting this opportunity to us. Without their involvement, this could not have been possible.” “We believe the critically ill population study will remove the final obstacle for us to receive emergency use authorization not only in Brazil, but potentially all over the world,” the CEO said. Pourhassan emphasized that this is the “most promising study” in the company’s history. “We now have generated important information to give ourselves the perfect opportunity to potentially obtain leronlimab’s first approval,” he added. Contact the author Uttara Choudhury at uttara@proactiveinvestors.com Follow her on Twitter: @UttaraProactive