The new trial would be run instead of adding an arm to an ongoing U.S. trial and would evaluate a lower dosage that performed better than a full amount in Astra’s studies, Soriot told Bloomberg in his first interview since the data was released.
“Now that we’ve found what looks like a better efficacy we have to validate this, so we need to do an additional study,” the CEO said.
Soriot said he did not expect the additional trial to hold up regulatory approvals in the U.K. and European Union, although clearance from the U.S. Food and Drug Administration may take longer because the regulator is unlikely to approve the vaccine on the basis of studies conducted elsewhere, especially given the questions over the results.
“Based on a thorough review of recent updates regarding the efficacy of new potential vaccines and other treatment options, we have made the strategic decision not to initiate our Equinox Phase 3 trial,” Equillium says.
The company plans to prioritize resources on expanding its program of using itolizumab in acute graft-versus-host disease, citing positive interim clinical data, as well as advancing lupus/lupus nephritis and uncontrolled asthma studies.