Abivertinib, one of Sorrento Therapeutics' (NASDAQ:SRNE) COVID-19 drug candidates, will be entering phase 2 testing in Brazil. This follows approval granted on Wednesday by the National Health Surveillance Agency (ANVISA), the country's healthcare regulator, which has cleared the U.S. company to advance the drug's development in the sprawling South American nation.
Abivertinib was originally designed to treat cancer; Sorrento believes it can limit the overactive immune systems seen in some COVID-19 patients.
In July, the drug was cleared for phase 2 testing in the U.S., but the Brazil study will have several differences. Among other distinctions, it will involve patients with mild, moderate, or severe forms of the illness; participants in the American trial are limited to severe COVID-19 cases. In Brazil, any hospitalized patient will be eligible; patients in the U.S. study must be in the intensive care unit and nonventilated.
All told, Sorrento aims to recruit 400 participants in the Brazil trial. It says that its partnerships with local organizations and medical systems in the country should help it enroll that number quickly.
Testing Abivertinib on a population outside the so-called "first world" is intentional.
"By targeting some of the geographies currently most impacted by COVID-19, we are able to implement a synergistic program to answer questions about safety and efficacy of our drug candidates in helping patients, while potentially accelerating enrollment timelines, reducing overall cost and opening up collaboration opportunities with local companies," Sorrento quoted CEO Henry Ji as saying.
The company is one of numerous biotechs around the world engaged in the fight against COVID-19; Abivertinib is among a clutch of drugs and vaccines Sorrento is trying to develop for this purpose.