Феърфилд
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Леронлимаб (Leronlimab; PRO 140)
Международное непатентованное наименование Леронлимаб (Leronlimab; PRO 140)
Торговое наименование -
Производитель, страна CytoDyn Inc., Canada
Механизм действия

Investigational Humanized Monoclonal Antibody to the Chemokine Receptor CCR5. Leronlimab may enhance immune response while mitigating cytokine storm.

 

The first as a combination therapy with HAART for HIV-infected patients and the second is for metastatic triple-negative breast cancer. 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. Leronlimab has completed nine 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).

Опыт использования

An Emergency Investigational New Drug Application (eIND) has been granted by the FDA for treatment of patients experiencing respiratory complications due to SARS-CoV-2.

 

Use currently being evaluated in a small number of patients with severe COVID19 via the FDA eIND.

Публикации COVID-19

Zhang C, Wu Z, Li JW, et al. The cytokine release syndrome (CRS) of severe COVID-19 and Interleukin-6 receptor (IL-6R) antagonist tocilizumab may be the key to reduce the mortality. Int J Antimicrob Agents. 2020. PMID: 32234467.

 

Zhang W, Zhao Y, Zhang F, et al. The use of anti-inflammatory drugs in the treatment of people with severe coronavirus disease 2019 (COVID-19): the perspectives of clinical immunologists from China. Clin Immunol. 2020. PMID: 32222466.

 

Zhou F, Yu T, Du R, et al. Clinical course and risk factors for mortality of adult inpatients with COVID-19 in Wuhan, China: a retrospective cohort study. Lancet 2020 Mar 11. PMID: 32171076.

 

Miao M, De Clercq E, Li G. Clinical significance of chemokine receptor antagonists. Expert Opin Drug Metab Toxicol. 2020 Jan;16(1):11-30. PMID: 31903790.

Клинические исследования
1.
Название протокола A Phase 2b/3, Randomized, Double Blind, Placebo Controlled, Adaptive Design Study to Evaluate the Efficacy and Safety of Leronlimab for Patients With Severe or Critical Coronavirus Disease 2019 (COVID-19)
Дата начала и окончания КИ April 15, 2020 - April 1, 2021
Название организации, проводящей КИ CytoDyn, Inc.
Страны USA
Фаза II
Кол-во пациентов 390
2.
Название протокола A Phase 2, Randomized, Double Blind, Placebo Controlled Study to Evaluate the Efficacy and Safety of Leronlimab for Mild to Moderate Coronavirus Disease 2019 (COVID-19)
Дата начала и окончания КИ April 1, 2020 - April 4, 2021
Название организации, проводящей КИ CytoDyn, Inc.
Страны USA
Фаза II
Кол-во пациентов 75