Sorrento Therapeutics has obtained the US Food and Drug Administration (FDA) clearance to initiate the Phase II/III clinical trial of abivertinib in Covid-19 patients who are hospitalised with severe pneumonia.

A new dual-target, small molecule tyrosine kinase inhibitor (TKI), abivertinib acts on the epidermal growth factor receptor (EGFR) and Bruton’s tyrosine kinase’s (BTK) mutant forms.

It is claimed to lower cytokine storm linked to acute respiratory distress syndrome (ARDS) in severe Covid-19 patients in the hospital.

The multicentre, multinational trial with a Phase II run-in will be carried out at various centres in the US, Brazil and Mexico. 

With two phases, the initial run-in phase is intended to establish the recommended Phase III dose (RP3D).

The trial will assess the safety and efficacy of abivertinib in Covid-19 patients with respiratory compromise.

The latest FDA clearance comes after the company successfully concluded parallel Phase II trials in the US and Brazil.

Trial findings showed that Covid-19 patients admitted to the hospital with severe pneumonia, especially those needing non-invasive ventilation or high flow oxygen, were found to have up to five-fold benefits following treatment with abivertinib than those needing low flow oxygen.

Sorrento Therapeutics chairman and CEO Dr Henry Ji said: “We are encouraged by the results from our Phase II study and excited to move abivertinib to the next stage to help these patients who have no good alternatives.”

In March this year, the company obtained FDA clearance for its Investigational New Drug application (IND) to initiate a Phase I trial of intranasal (IN) STI-2099 (COVIDROPS) for Covid-19.

This trial has been designed to assess the safety and pharmacokinetics of IN STI-2099 in healthy subjects and mild Covid-19 patients.