*TAVALISSE is not FDA-approved for use in COVID-19.
SYK is involved in the intracellular signaling pathways of many different immune cells. Therefore, SYK inhibition may improve outcomes in patients with COVID-19 via inhibition of key Fc gamma receptor (FcγR) and c-type lectin receptor (CLR) mediated drivers of pathology such as pro-inflammatory cytokine release by monocytes and macrophages, production of neutrophil extracellular traps (NETs) by neutrophils, and platelet aggregation.3,4,5,6 Furthermore, SYK inhibition in neutrophils and platelets may lead to decreased thromboinflammation, alleviating organ dysfunction in critically ill patients with COVID-19.
1Investigational compound in this indication and has not been submitted for FDA review
2Fu Y. et al. Understanding SARS-CoV-2-Mediated Inflammatory Responses: From Mechanisms to Potential Therapeutic Tools. Virologica Sinica. March 3, 2020
3Nadeem A. et al. Inhibition of spleen tyrosine kinase signaling protects against acute lung injury through blockade of NADPH oxidase and IL-17A in neutrophils and γδT cells respectively in mice. International Immunopharmacology 68 (2019) 39–47.
TAVALISSE® (fostamatinib disodium hexahydrate) is a selective, oral spleen tyrosine kinase (SYK) inhibitor being evaluated in clinical trials for the treatment of hospitalized patients with COVID-19.
The TAVALISSE COVID-19 program covers a broad range of hospitalized patients. Clinical trials are being conducted to address the full spectrum of patient clinical status, from mild to severe.
NIH P2 Study = National Heart, Lung, and Blood Institute (NHLBI) Study, part of the National Institutes of Health (NIH), in collaboration with Inova Health System
The National Heart, Lung, and Blood Institute (NHLBI), part of the National Institutes of Health (NIH), in collaboration with Inova Health System, sponsored a Phase 2 clinical study to evaluate fostamatinib in hospitalized patients with COVID-19. The study met its primary endpoint of safety and showed broad and consistent improvement in numerous efficacy endpoints including mortality, ordinal scale assessment, and number of days in the ICU. Results from this study were published in the peer-reviewed journal, Clinical Infectious Diseases.
1Standard of care includes any treatments currently in use to treat the underlying disease, or comorbidities associated with COVID-19 (eg, remdesivir).
Rigel’s multi-center, double-blind, placebo-controlled, Phase 3 clinical trial in hospitalized patients with COVID-19 enrolled 280 patients that were randomly assigned to either fostamatinib plus standard of care (SOC) or matched placebo plus SOC. Top-line results were reported in November 2022. Rigel was awarded $16.5 million by the U.S. Department of Defense to support funding of this trial. More detail on the study can be found on clinicaltrials.gov: NCT04629703.
1Standard of care includes any treatments currently in use to treat the underlying disease, or comorbidities associated with COVID-19 (eg, remdesivir).
ACTIV-4 Host Tissue is a randomized, placebo-controlled Phase 2/3 trial of therapies, including fostamatinib, targeting the host response to COVID-19 in hospitalized patients. More detail on the study can be found on clinicaltrials.gov: NCT04924660.
1Standard of care includes any treatments currently in use to treat the underlying disease, or comorbidities associated with COVID-19 (eg, remdesivir).
*Following an interim analysis TXA127 and TRV027 study arms were discontinued after meeting the inferiority stopping criteria
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