CytoDyn Inc has announced treatment of the first patient in its pivotal Phase 3 trial CD16 in Brazil for critically ill Coronavirus (COVID-19) patients, which it is conducting with Brazil’s BIOMM and academic research organisation (ARO).
The Vancouver, Washington-based late-stage biotechnology company said an interim analysis will be conducted 28 days following the enrollment of 127 patients.
On September 9, the company announced the treatment of the first patient in its other pivotal Phase 3 trial in Brazil, CD17. An interim analysis for this trial will be conducted 28 days after 245 patients have been enrolled, it added.
READ: CytoDyn says Brazil approves pivotal Phase 3 clinical trial of leronlimab in critically ill coronavirus patients
CytoDyn said the new pivotal Phase 3 clinical trial will focus on hospitalized critically ill COVID-19 patients who require mechanical and invasive ventilation or Extracorporeal Membrane Oxygenation (ECMO). Its flagship Leronlimab drug will be administered via intravenous therapy (IV) in four doses or 700 milligrams (mg) per week. The trial is being conducted across 29 research centers with 316 patients.
“The CytoDyn team, along with BIOMM and ARO, have worked diligently to initiate two pivotal Phase 3 trials in Brazil, and we are excited about the trials’ potential results,” CytoDyn president and CEO Dr Nader Pourhassan said in a statement.
“We are seeing strong optimism from all of the doctors and individuals involved in this project, especially since the primary endpoint for CD16 is similar to an endpoint in our past CD12 trial, which produced 166% better results in the leronlimab arm versus placebo.”
Importantly, CytoDyn said the CD16 trial provides for two additional doses and delivery via IV, which allows leronlimab absorption to occur within 1-2 hours of being administered compared to 2-3 days when administered via subcutaneous (SQ) dosing.
“We continue to be very impressed by the execution and professionalism of our partners in Brazil and, accordingly, anticipate a relatively rapid rate of enrollment if the patients are available, including the scheduled interim analyses for both Phase 3 trials,” Pourhassan added.
“We are hopeful to be in a position to make leronlimab available for patients with severe or critical symptoms in the coming months.”
The US Food and Drug Administration (FDA) has granted CytoDyn Fast Track designation to explore two potential indications using leronlimab to treat Human Immunodeficiency Virus (HIV) and metastatic cancer. The first indication is a combination therapy with HAART for HIV-infected patients, and the second is for metastatic triple-negative breast cancer (mTNBC).
Contact the author at stephen.gunnion@proactiveinvestors.com