Sorrento Therapeutics Inc (SRNE)

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In the US study, patients in category 5 showed a 20% improvement in the primary endpoint, and in the Brazil study, a 25% improvement. In the US study, patients in category 5 treated with Abivertinib were discharged from the hospital 2 days sooner than those in the Control Group (8.6 vs. 10.6 days). Overall, in both studies patients who were in category 5, but not in category < 4, showed improvement with Abivertinib treatment. Based upon these preliminary results, a pivotal multi-country, multi-center pivotal Phase 3 study is being planned in 400 patients (randomized 1:1) on the At-Risk Hospitalized COVID-19 Patients requiring oxygen support via non-invasive ventilation or high flow oxygen at baseline (category 5 patients).

“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,” stated Dr. Mike Royal, Chief Medical Officer of Sorrento Therapeutics. “Abivertinib has the potential to fill this unmet need and significantly reduce progression to intubation, mechanical ventilation and death.”