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  • Treating COVID-19 with Leronlimab (PRO 140): Additional Patients Added to EUA, U.S. FDA Approves First Full Randomized Trial, Amarex Submits Second IND Application

Treating COVID-19 with Leronlimab (PRO 140): Additional Patients Added to EUA, U.S. FDA Approves First Full Randomized Trial, Amarex Submits Second IND Application

Germantown, MD, USA (April 02, 2020) – Since early March, Amarex has worked closely with its client CytoDyn Inc. to achieve U.S. FDA approval for the use of leronlimab (PRO 140), a monoclonal antibody product currently used as an Investigation New Drug (IND) in the treatment of HIV/AIDS, oncology and other disease indications, in the treatment of coronavirus disease 2019 (COVID-19). Leronlimab is a humanized IgG4 mAb that blocks the CCR5 receptor and appears to modulate immune cell trafficking to site of inflammation.

Rapid approval was granted by the U.S. FDA for an Emergency Use Authorization (EUA) to treat an initial cohort of severely ill patients with COVID-19. As of today, 10 patients with mild-to-moderate respiratory complications caused by SARS-CoV-2 have been treated with leronlimab. Initial test of immunological markers results positive results, including a reduced hyper-immune response in patients.

The FDA has also approved a rushed IND application for a Phase 2, randomized, double blind, placebo-controlled clinical study to evaluate efficacy and safety of leronlimab in patients with mild to moderate document COVID-19 symptoms. Enrollment will begin immediately, and plans to treat 75 patients in up to 10 centers across the United States.

Amarex has now submitted a second IND application to the U.S. FDA for a clinical trial to treat severely ill COVID-19 patients with leronlimab. There is an extremely high mortality rate associated with COVID-19 patients requiring a mechanical ventilator. This study plans to evaluate the efficacy and safety of leronlimab in patients with a two week mortality rate.

About CytoDyn

CytoDyn is a biotechnology company developing innovative treatments for multiple therapeutic indications based on leronlimab, a novel humanized monoclonal antibody targeting the CCR5 receptor. CCR5 appears to play a key role in the ability of HIV to enter and infect healthy T-cells. The CCR5 receptor also appears to be implicated in tumor metastasis and in immune-mediated illnesses, such as GvHD and NASH. CytoDyn has successfully completed a Phase 3 pivotal trial with leronlimab in combination with standard anti-retroviral therapies in HIV-infected treatment-experienced patients. CytoDyn plans to seek FDA approval for leronlimab in combination therapy and plans to complete the filing of a Biologics License Application (BLA) in the first quarter of 2020 for that indication. CytoDyn is also conducting a Phase 3 investigative trial with leronlimab as a once-weekly monotherapy for HIV-infected patients and plans to initiate a registration-directed study of leronlimab monotherapy indication, which if successful, could support a label extension. Clinical results to date from multiple trials have shown that leronlimab can significantly reduce viral burden in people infected with HIV with no reported drug-related serious adverse events (SAEs). Moreover, results from a Phase 2b clinical trial demonstrated that leronlimab monotherapy can prevent viral escape in HIV-infected patients, with some patients on leronlimab monotherapy remaining virally suppressed for more than five years. CytoDyn is also conducting a Phase 2 trial to evaluate leronlimab for the prevention of GvHD and a Phase 1b/2 clinical trial with leronlimab in metastatic triple-negative breast cancer. More information is at www.cytodyn.com.

About Amarex Clinical Research, LLC, an NSF International company

Amarex is a global, full service Contract Research Organization (CRO), whose leadership team has significant expertise conducting biomedical research, and whose combined experience includes the design and conduct of several hundred clinical research projects in many therapeutic indications. Amarex provides comprehensive services in Project Management (Phase I-IV, BE/BA, PK/PD), Regulatory Affairs (FDA Applications and meetings, Applications to International Health Authorities, GxP Compliance Audits), Clinical Operations, Adaptive Study Designs, Statistical Analysis, Data Management, Medical Safety and Pharmacovigilance, and General Consulting. Amarex can take your product through the entire approval process, from creating the regulatory approval strategy, to conducting trials, to writing the marketing approval application. Join our growing list of clients with approved products. Amarex provides high quality and cost efficient services. For more information visit www.amarexus.com.

Amarex Contact:
Patrick J. Burke
Business Development
patrickb@amarexcro.com

20201 Century Blvd., Fourth Floor
Germantown, MD 20874 USA
301 528 7000
www.amarexus.com

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