Sorrento : FDA Oks Abivertinib For Phase 2 Study In Patients With Moderate To Severe COVID-19

(RTTNews) - Sorrento Therapeutics Inc. (SRNE) said that it received clearance from the FDA to initiate a Phase 2 trial of Abivertinib in patients with COVID-19 who have moderate to severe pulmonary symptoms.

In Monday regular trade, SRNE is currently trading at $8.05 up $1.08, or 15.42 percent.

Abivertinib is a novel small molecule tyrosine kinase inhibitor (TKI) that selectively targets both mutant forms of the epidermal growth factor receptor (EGFR) and Bruton's tyrosine kinase (BTK).

In May, 2020, Sorrento had entered into a binding term sheet for an exclusive license to ACEA Therapeutics' Abivertinib across all indications for all territories outside of China. The parties have since entered into an exclusive license agreement.

Abivertinib has been studied in over 600 patients worldwide in various oncologic indications, including one registration trial in non-small cell lung cancer. Most treatment-related adverse events (AEs) were grade 1 or 2, the most common of which were transaminase elevations and diarrhea, which are generally considered common for TKIs.

Other common treatment-related AEs included anemia, neutropenia and thrombocytopenia, each of which are generally considered typical AEs with long-term use of TKIs. No unexpected AEs were reported.