Late-stage biotechnology company, CytoDyn (OTCMKTS:CYDY), which is developing Inc leronlimab, having potential for myriad therapeutic indications, on September 9, 2021 announced treatment of the first patient in Phase 3 COVID-19 trial in Brazil for patients having severe symptoms.
Interim analysis would be done in 28 days after enrolling 245 patients, 40% of the total patients enrolled in the trial. The phase 3 trial is being done for serious covid patients conducted by Academic Research Organization Albert Einstein Israelite Hospital.
The trial is being done for providing ANVISA, Brazils regulatory authority with the data for advancing the drug’s availability to covid patients. To be conducted in 35 clinical sites having 612 patients , the trial is being done for patients who are hospitalized and needing oxygenation support.
Nader Pourhassan, Ph.D., CytoDyns President and Chief Executive Officer, said that that it is encouraging the trial is underway and the company is keen on reaching commented, We are very encouraged enrollment for this first trial and believe that the second trial would also be done soon as the regulatory body has passed it with condition of extra information about CMC , which would be done by September 13.
The President also thanked his team who did the CD12 trial in U.S. gaining lot of information for designing the two studies. In addition , the representative thanked the ARO team for a good job in addition to the BIOMM team.
The U.S. Food and Drug Administration (FDA) approved CytoDyn’s Fast Track designation to for exploring potential indications using leronlimab for treating Human Immunodeficiency Virus and metastatic cancer.