On Mar. 31, 2022, Sorrento Therapeutics announced that the U.S. Food and Drug Administration (FDA) had given clearance to commence the Phase 3 clinical trial of Abivertinib in severe COVID-19 patients (hospitalized patients with respiratory compromise requiring oxygen supplementation).

The clinical trial was conducted in 2 phases, and the initial run-in defined the RP3D. In October 2021, Sorrento released preliminary results of two phase 2 studies that seemed to show that patients hospitalized with severe pneumonia due to COVID-19, especially those requiring non-invasive ventilation or high flow oxygen supplementation, were up to 5-fold more likely to benefit from Abivertinib therapy than those patients who required low flow supplementation. Such patients represent a high-risk population with few treatment options.

The study will be conducted at multiple sites in the USA, Mexico and Brazil. “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,” said Dr. Henry Ji, Chairman and CEO of Sorrento.

Sorrento believes the availability of an oral dosage form to manage inflammatory disease progression is very relevant for severely afflicted patients with COVID-19-induced respiratory failure and potentially non-COVID acute respiratory distress syndrome (ARDS).

This treatment has the potential to provide significant benefits across the globe with respect to logistical access, scalability and affordability by potentially providing a treatment in a convenient oral dosage form. Sorrento intends to explore the administration of Abivertinib for severe non-COVID related pneumonia and ARDS patients, as the mechanism of disease progression is very similar and the current medical options for treatment are limited.