Benzinga | Jun 29, 2021 07:34AM EDT

Rigel Pharmaceuticals Announces Fostamatinib, The Company's Novel Oral Spleen Tyrosine Kinase Inhibitor, Selected for NIH ACTIV-4 COVID-19 Clinical Trial

Rigel Pharmaceuticals, Inc. (NASDAQ:RIGL), today announced that fostamatinib, the Company's novel oral spleen tyrosine kinase (SYK) inhibitor, has been selected for a National Institutes of Health (NIH) ACTIV-4 (Accelerating COVID-19 Therapeutic Interventions and Vaccines) trial in hospitalized patients with COVID-19.

The ACTIV-4 Host Tissue trial is a large, multi-site trial funded by the National Heart, Lung, and Blood Institute (NHLBI) of the NIH and coordinated by Vanderbilt University Medical Center (VUMC). The trial is evaluating treatments, including fostamatinib, that aim to protect and heal host tissues in hospitalized patients with COVID-19.

This study follows a recently completed NHLBI/NIH-sponsored Phase 2 study (NCT04579393), with positive topline results, that evaluated fostamatinib in hospitalized adults 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. These data were submitted as part of a request for an emergency use authorization (EUA) from the U.S. Food and Drug Administration (FDA) for fostamatinib in hospitalized patients diagnosed with COVID-19. These data have also been submitted for publication in a peer-reviewed medical journal.

"Despite welcome advances in some areas, COVID-19 and its variants will remain a real public health threat for the foreseeable future, particularly for those with pre-existing conditions," said Raul Rodriguez, Rigel's president and CEO. "The teams at the NIH and VUMC are ideally positioned to continue to advance clinical efforts for COVID-19 related lung injuries, including the study of fostamatinib's potential to treat and prevent conditions caused by an overactive immune system in COVID-19 patients," he added.

"Fostamatinib will be the fourth arm of our ACTIV-4 Host Tissue trial. The drugs tested on this platform offer an opportunity to better understand both the central pathways of disease progression and better ways to protect and heal the host tissues damaged by COVID-19," said Dr. Sean P. Collins, MD, MSc, ACTIV-4 Host Tissue Principal Investigator and Professor of Emergency Medicine at VUMC.