COVID-19 Treatment Enters Phase 2 Study
Novant Health announced it is initiating patient enrollment in CytoDyn’s Phase 2 randomized clinical trial for COVID-19 patients with mild-to-moderate indications, being treated with leronlimab (PRO 140), a CCR5 antagonist.
Novant Health is the second clinical trial site in the USA.
Additionally, CytoDyn announced it is initiating a Phase 2b/3 study for severely ill COVID-19 patients, who are expected to be administered leronlimab for two weeks.
The primary endpoint of this study is the mortality rate at 28 days and a secondary endpoint of mortality rate at 14 days.
On April 7, 2020, CytoDyn Inc. said in a press release that leronlimab is an investigational humanized IgG4 mAb that blocks CCR5, a cellular receptor that is important in HIV infection, tumor metastases, and other diseases, including NASH.
The CCR5 receptor appears to play a central role in modulating immune cell trafficking to sites of inflammation.
It may be crucial in the development of acute graft-versus-host disease (GvHD) and other inflammatory conditions.
Clinical studies by others further support the concept that blocking CCR5 using a chemical inhibitor can reduce the clinical impact of acute GvHD without significantly affecting the engraftment of transplanted bone marrow stem cells.
CytoDyn is currently conducting a Phase 2 clinical study with leronlimab to support further the concept that the CCR5 receptor on engrafted cells is critical for the development of acute GvHD, blocking the CCR5 receptor from recognizing specific immune signaling molecules is a viable approach to mitigating acute GvHD.
The FDA has granted “orphan drug” designation to leronlimab for the prevention of GvHD.
Leronlimab has completed 9 clinical trials in over 800 people, including meeting its primary endpoints in a pivotal Phase 3 trial (leronlimab in combination with standard antiretroviral therapies in HIV-infected treatment-experienced patients).
The Company said it expects to perform an interim analysis of the data from 50 patients.
CytoDyn is a late-stage biotechnology company developing innovative treatments for multiple therapeutic indications based on leronlimab, a novel humanized monoclonal antibody targeting the CCR5 receptor.
COVID-19 disease treatment news published by Precision Vaccinations.