Amarex Assists with Emergency Use Authorization (EUA) for COVID-19 Treatment
Germantown, MD, USA (March 20, 2020) - In the past week Amarex worked with client CytoDyn to prepare, submit and achieve FDA approval for an EUA for CytoDyn’s leronlimab, a monoclonal antibody product, as a potential treatment for coronavirus disease 2019 (COVID-19). Amarex CEO, Dr. Kazem Kazempour, explained, “Cytodyn’s product has the potential to control the body’s hyper-immune response to coronavirus infection which contributes to life threatening side-effects of the disease.”
Amarex has been working with CytoDyn for several years on the development of leronlimab as a treatment for HIV infection, and several other disease indications, and the drug has demonstrated a favorable safety profile in clinical trials to date. Dr. Kazempour added, “Leronlimab has the potential to help the most severe cases of COVID-19 and we are very hopeful for the patients currently in need and grateful for the swift action of the FDA for the EUA approval. Two patients have already been treated and we are waiting to learn the effect”.
CytoDyn has a good supply of the drug available and the ability to ramp up manufacturing quickly if it appears to be effective for treating COVID-19. Amarex’s Sr. VP of Clinical Operations, Dr. Kush Dhody, added, “ Amarex is spearheading the effort to obtain FDA approval for expanded emergency use of the drug and coordinate supply of the drug to the hospitals and clinics."
Additionally, Amarex has submitted a rush IND application for leronlimab as a treatment of adult patients with mild-to-moderate symptoms of respiratory illness caused by COVID-19. If approved this will result in a Phase 2, Randomized, Double-Blind, Placebo-Controlled Study.
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.
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