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Immunomodulatory Therapeutic Proteins in COVID-19: Current Clinical Development and Clinical Pharmacology

Ping Ji1, Jianmeng Chen1, Amit Golding2

  • 1Division of Inflammation and Immune Pharmacology, Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland, USA.

Journal of Clinical Pharmacology
|August 12, 2020
PubMed

Insights

This review covers clinical pharmacology for developing immunomodulatory proteins to treat severe COVID-19. These therapies aim to reduce the dangerous inflammatory response seen in patients with SARS-CoV-2 infection.

Area of Science:

  • Immunology
  • Pharmacology
  • Infectious Diseases

Background:

  • The COVID-19 pandemic, caused by SARS-CoV-2, has resulted in significant global mortality.
  • Severe COVID-19 is associated with acute respiratory distress and a cytokine storm, a dangerous overproduction of inflammatory signals.
  • Existing treatments focus on managing symptoms, but novel therapeutic strategies are needed for the systemic inflammatory response.

Purpose of the Study:

  • To review clinical pharmacology considerations for immunomodulatory therapeutic proteins.
  • To discuss the development of biological therapies targeting the heightened inflammatory response in COVID-19.
  • To provide insights into mitigating pulmonary complications and systemic inflammation in advanced COVID-19.

Main Methods:

  • Literature review of clinical pharmacology principles.
  • Analysis of immunomodulatory biological therapies under investigation.
  • Examination of cytokine upregulation in severe COVID-19 pathogenesis.

Main Results:

  • Severe COVID-19 involves significant cytokine dysregulation.
  • Immunomodulatory proteins show promise in preclinical and early clinical studies.
  • Clinical pharmacology is crucial for optimizing dosing, safety, and efficacy of these biologics.

Conclusions:

  • Immunomodulatory biological therapies are a promising avenue for treating severe COVID-19.
  • Careful consideration of clinical pharmacology is essential for successful therapeutic protein development.
  • Targeting the inflammatory cascade may improve outcomes for patients with advanced COVID-19 and acute respiratory distress.
Keywords:
COVID-19biologicsclinical pharmacologyimmunomodulatoryreview

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