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May 28, 2021

Biomm to seek ANVISA approval for Phase III Covid-19 trials

CytoDyn plans to conduct Phase III trials of leronlimab for Covid-19 at up to 45 clinical centres in Brazil.

Biomm, a distribution partner of CytoDyn, is set to seek authorisation from the Brazilian National Health Surveillance Agency (ANVISA) to conduct two Phase III clinical trials of leronlimab (PRO 140) in Covid-19 patients.

Marketed as Vyrologix, leronlimab is an investigational humanised immunoglobulin G4 monoclonal antibody that hinders C-C chemokine receptor type 5 (CCR5).

CCR5 is a cellular receptor vital in HIV infection, tumour metastases, nonalcoholic steatohepatitis, as well as other conditions.

Once ANVISA approval is obtained, the Phase III trials will be carried out by a Brazilian academic research organisation, Albert Einstein Israelite Hospital (AEIH).

CytoDyn signed an agreement to collaborate with AEIH earlier this month to conduct these trials.

These Phase III trials for severe and critically ill Covid-19 patients will offer the necessary data required by ANVISA to make leronlimab available for this indication in the country.

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CytoDyn noted that these trials will be carried out at up to 45 clinical centres, enrolling 306 critically ill subjects and 594 severely ill subjects. An interim analysis will be performed after enrolling approximately 40% of subjects in each study.

CytoDyn president and CEO Nader Pourhassan said: “We look forward to continuing to identify partnerships in other countries experiencing a surge in Covid-19 cases similar to Brazil, the Philippines and India where leronlimab could potentially save lives.

“We will update investors on the next investment community call on the design of these trials based on the wealth of information we have learned from our previous Covid-19 trials.”

In April this year, CytoDyn and Biomm signed an exclusive supply and distribution agreement that will enable the latter to leronlimab in Brazil on receiving regulatory approval.

Leronlimab has so far been evaluated in 11 clinical trials in nearly 1,200 individuals. It also met primary goals in a Phase III trial, when administered along with standard antiretroviral therapies in HIV patients who were treatment-experienced.

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