Sorrento Therapeutics Inc. (NASDAQ: SRNE) has announced top-line interim findings from two-second phase studies meant to identify hospitalized patients with COVID-19 induced pneumonia and respiratory depression that can potentially respond to oral Abivertinib treatment.
Studies evaluating Abivertinib in the US and Brazil
One study is taking place in the US, and it is titled “A Phase 2, Double Blinded, Randomized Study of the Efficacy and Safety of STI-5656 (Abivertinib Maleate) With Standard of Care Versus Standard of Care in Subjects Hospitalized With COVID-19.” The other study taking place in Brazil is titled, “A Phase 2, Randomized, Double-Blind, Placebo-controlled Study of the Safety and Efficacy of STI-5656 (Abivertinib Maleate) in Subjects Hospitalized Due to COVID-19.”
Both studies were aimed to see if Abivertinib could help patients with COVID-19-induced respiratory depression by reducing the inflammatory cytokine storm. Based on the degree of COVID-19 respiratory depression at baseline, it was also critical to identify the patient population most likely to react to treatment.
Abivertinib targets mutant versions of BTK and EGFR
Abivertinib is a new tyrosine kinase inhibitor (TKI) that targets both mutant versions of the epidermal growth factor receptor (EGFR) and Bruton’s tyrosine kinase (BTK). The drug candidate interacts with the BTK receptor in an irreversible manner, preventing it from being phosphorylated. It has demonstrated powerful immunomodulatory actions in vitro as a result of this impact, including potent suppression of major pro-inflammatory cytokine production, such as IL-6, IL-1 beta, and TNF-alpha. These cytokines have been linked to ARDS,) cytokine storm or cytokine release syndrome (CRS), and COVID-19 disease progression, all of which are related to poor patient outcomes.
Sorrento Chief Medical Officer Dr. Mike Royal said, “Patients on non-invasive ventilation or high flow oxygen supplementation due to COVID-19-induced respiratory failure represent a sicker and at-risk population with few available treatment options. Abivertinib has the potential to fill this unmet need and significantly reduce progression to intubation, mechanical ventilation and death.”
