Close

CytoDyn and AEIH to begin trials of leronlimab in severe Covid-19

Subscribe

- Never miss a story with notifications

- Gain full access to our premium content

- Browse free from any location or device.

Media Packs

Expand Your Reach With Our Customized Solutions Empowering Your Campaigns To Maximize Your Reach & Drive Real Results!

– Access the Media Pack Now

– Book a Conference Call

– Leave Message for Us to Get Back

Related stories

Alexion and DHL Partner for 100% Sustainable Aviation Fuel

Dublin, Alexion, AstraZeneca Rare Disease, has partnered with DHL...

Why Early Intervention Is Key To Managing Chronic Health Concerns

Proactive health management is essential for maintaining a good...

New Data Shows Gazyva’s Superiority in Lupus Nephritis

The New England Journal of Medicine has published detailed...

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.

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.

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.

 

Latest stories

Related stories

Alexion and DHL Partner for 100% Sustainable Aviation Fuel

Dublin, Alexion, AstraZeneca Rare Disease, has partnered with DHL...

Why Early Intervention Is Key To Managing Chronic Health Concerns

Proactive health management is essential for maintaining a good...

New Data Shows Gazyva’s Superiority in Lupus Nephritis

The New England Journal of Medicine has published detailed...

Subscribe

- Never miss a story with notifications

- Gain full access to our premium content

- Browse free from any location or device.

Media Packs

Expand Your Reach With Our Customized Solutions Empowering Your Campaigns To Maximize Your Reach & Drive Real Results!

– Access the Media Pack Now

– Book a Conference Call

– Leave Message for Us to Get Back