According to CytoDyn Inc., Brazil approves the pivotal phase 3 clinical trial with leronlimab in critically ill coronavirus patients

CEO Nader Pourhassan said the “chances of success” will be greatly improved in this Phase 3 study (CD16) in which four 700 mg doses of IV are administered to critically ill COVID-19 patients during the first four weeks of treatment

CytoDyn Inc announced that the Brazilian regulator Agência Nacional de Vigilância Sanitária (ANVISA) has approved the start of an additional phase 3 clinical trial CD16 with its flagship drug Leronlimab for the treatment of critically ill coronavirus (COVID-19) patients.

The Vancouver, Washington-based late-stage biotechnology company said the new clinical trial will focus on hospitalized COVID-19 patients in critical condition who require mechanical and invasive ventilation or extracorporeal membrane oxygenation (ECMO).

The study will be carried out at 22 research centers with a total of 316 patients. An interim analysis will be performed after 40% of patients have entered the study and have completed a 28-day study. CytoDyn’s first goal is to recruit 127 patients as quickly as possible.

READ: CytoDyn Treats First Patient With Leronlimab In Its Pivotal Phase 3 Coronavirus Study In Brazil For Patients With Severe Symptoms

The pivotal phase 3 study for seriously ill COVID-19 patients is being carried out by an academic research organization (ARO) called Albert Einstein Israelite Hospital (AEIH) in São Paulo, Brazil, in coordination with CytoDyn and BIOMM, the company’s exclusive partner for the Commercialization carried out by Leronlimab in Brazil.

In a statement, Nader Pourhassan, CEO of CytoDyn said, “We are delighted with this news and what it means for Leronlimab’s potential ability to successfully treat critically ill COVID-19 patients around the world in the future. We believe in IV treatment in this study “will have a tremendous advantage over subcutaneous (SQ) injection treatment, which was the route of administration in our last COVID-19 study (CD12) in the US.”

“Leronlimab is absorbed into the body within one to two hours after IV administration. In contrast, an SQ injection could take two to three days before leronlimab is fully absorbed. With a seriously ill population, time is of the essence. In the previous study (CD12), we believe that the 30% survival benefit (after 28 days) in the leronlimab arm over placebo could have been much higher if IV administration had been used instead of SQ and the treatment had been four instead Dosages would be done by just two. “

In the company’s CD12 study, the survival benefit in the critically ill population was 78% after the first week after the first dose of leronlimab and 82% after the second week.

“Treatment with leronlimab consisted of only two doses (day 0 and day 7); from the 14th to the 28th day, the survival rate decreased from 82% to 30% if no additional doses of Leronlimab were administered, ”Pourhassan said. “In this study (CD16) there will be four doses during the first four weeks of treatment, and with IV administration we believe our chances of success will be greatly improved.”

The primary endpoint in the CD16 study is time to recovery.

“This similar endpoint in the previous study (CD12) showed that the time to hospital discharge was 166% better for the seriously ill population than for placebo,” said Pourhassan. “We are therefore very excited to see the results of the interim analysis. We are still grateful to the ARO and BIOMM teams for their work that has brought us to this point. “

The US Food and Drug Administration (FDA) has granted CytoDyn Fast Track status to investigate two potential indications with leronlimab for the treatment of human immunodeficiency virus (HIV) and metastatic cancer. The first indication is a combination therapy with HAART in HIV-infected patients, the second in metastatic triple negative breast cancer (mTNBC).

Contact the author Uttara Choudhury at [email protected]

Follow her on Twitter: @UttaraProactive