July 20, 2020 -- Sorrento Therapeutics received clearance from the U.S. Food and Drug Administration to initiate a phase II clinical trial evaluating abivertinib for treatment of moderate and severe COVID-19 patients.
The tyrosine kinase inhibitor, licensed from Acea Therapuetics, is a potent immunomodulator that inhibits pro-inflammatory cytokine production, including interleukin 1 beta (IL-1beta), IL-6, and tumor necrosis factor alpha (TNF alpha). These cytokines have been associated with cytokine storms and COVID-19 progression with poor outcomes in patients with acute respiratory distress syndrome (ARDS).
The phase II, double-blind, randomized clinical study (NCT04440007) will be initially conducted in the U.S.
Abivertinib has previously been studied in over 600 patients with various oncologic indications.