First Patient Treated with CCR5 Antagonist in Phase 3 Study in Brazil for Patients with Severe COVID-19 Symptoms
Washington-based CytoDyn Inc. announced on September 9, 2021, the treatment of the first patient in its pivotal Phase 3 clinical trial in Brazil for patients with severe COVID-19 symptoms.
An interim analysis will be conducted 28 days following the enrollment of 245 patients.
CytoDyn's Vyrologix™ Leronlimab (PRO 140) is a CCR5 antagonist with the potential for multiple therapeutic indications.
This trial is intended to provide Brazil’s regulatory authority, ANVISA, with the requisite data to consider advancing the availability of leronlimab to Brazilians infected with COVID-19.
As previously announced, this pivotal Phase 3 trial for severe COVID-19 patients is being conducted by Academic Research Organization Albert Einstein Israelite Hospital. The trial will be conducted in up to 35 clinical sites with 612 patients who are hospitalized and in need of oxygenation support.
The U.S. Food and Drug Administration previously granted CytoDyn Fast Track designation to explore two potential indications using leronlimab to treat HIV and metastatic cancer.
CytoDyn is a late-stage biotechnology company developing innovative treatments for multiple therapeutic indications using leronlimab, a novel humanized monoclonal antibody targeting the CCR5 receptor.