SRNE - Sorrento granted FDA clearance to start late-stage trial for COVID-19 therapy
San Diego, California-based biotech, Sorrento Therapeutics (NASDAQ:SRNE), announced on Thursday that the U.S. Food and Drug Administration (FDA) cleared its request to begin a Phase 3 trial for Abivertinib, an experimental therapy for COVID-19. The trial designed to study Abivertinib as a potential therapy for severe COVID-19 is expected to proceed in two phases in multiple sites across the U.S., Mexico, and Brazil, the company said. The initial run-in will be focused on identifying the recommended Phase 3 dose. “We are encouraged by the results from our Phase 2 study, and excited to move Abivertinib to the next stage to help these patients who have no good alternatives,” Chief Executive Henry Ji. According to early results from the mid-stage trial, the hospitalized COVID-19 patients, who received the oral tyrosine kinase inhibitor, were up to 5-fold more likely to benefit from the therapy, compared to those who underwent low flow supplementation.
For further details see:
Sorrento granted FDA clearance to start late-stage trial for COVID-19 therapy