CytoDyn entered into an agreement to collaborate with AEIH to conduct the Covid-19 trials. Credit: Fusion Medical Animation on Unsplash.

This development is part of Cytodyn’s agreement to collaborate with AEIH to carry out the trials in up to 45 clinical sites in the country.

These Phase III trials are anticipated to deliver the data required by the Brazilian regulatory authority, ANVISA, to make leronlimab available for Covid-19 patients in the country.

Go deeper with GlobalData

Data Insights

The gold standard of business intelligence.

Find out more

Related Company Profiles

View all

The company plans to carry out interim analysis in October and November when the trial enrols 120 critically ill patients or 40% of the 300 subjects.

CytoDyn chief operating officer and Clinical Development head Chris Recknor said: “This ARO has conducted multiple large-scale Covid trials for many pharmaceutical companies. CytoDyn is utilising their extensive experience to develop and conduct our CD16 and CD17 Covid-19 trials.

“With approximately 1,500 patients in total for both trials, we anticipate having adequate power in each trial to achieve a significant p-value for our endpoints and will be performing an interim analysis after 40% of the critically ill patients are enrolled.”

An investigational humanised IgG4 monoclonal antibody, leronlimab hinders C-C chemokine receptor type 5 (CCR5), a cellular receptor vital in HIV infection, tumour metastases and various diseases.

How well do you really know your competitors?

Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.

Company Profile – free sample

Thank you!

Your download email will arrive shortly

Not ready to buy yet? Download a free sample

We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form

By GlobalData
Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.

Leronlimab has so far been analysed in 11 clinical trials in over 1,200 individuals. It met primary endpoints in a Phase III trial, when combined with standard antiretroviral therapies in HIV patients who are treatment-experienced.

In nine clinical trials, leronlimab was found to considerably lower or regulate HIV viral load in people.

The leronlimab antibody is considered an antiviral agent with less side effects and reduced dosing requirements compared to existing daily drug treatme.

Last month, CytoDyn and Biomm signed an exclusive supply and distribution agreement that will enable the latter to market leronlimab in Brazil on receiving regulatory approval.