Synairgen has completed the recruitment of 610 subjects for its global Phase III SPRINTER trial (SG018) of inhaled interferon beta, SNG001, to treat hospitalised Covid-19 patients.
The company’s double-blind, randomised, placebo-controlled Covid-19 trial is being conducted in 17 countries.
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Statistical analysis and quality assurance will be concluded once the last subjects complete the initial trial period of 35 days.
Synairgen noted that the top-line results from the trial are anticipated early next year.
Upon successful completion of the Phase III study, the company plans to file an emergency use authorization application with the US Food and Drug Administration (FDA) to treat Covid-19 patients who require hospitalisation.
Synairgen CEO Richard Marsden said: “Even with extensive vaccine programmes, in the US alone, thousands of patients a day are still being hospitalised due to serious Covid-19 symptoms. Doctors have highlighted the urgent need for more treatment options for these patients.
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By GlobalData“We believe that SNG001, our investigational inhaled formulation of interferon beta, a naturally occurring, broad-spectrum antiviral protein, could offer a compelling new treatment option.”
The company will continue to work together with Parexel division Parexel Biotech on the SPRINTER study.
The FDA granted Fast Track status for SG018, which the company primarily aims to develop as potentially the first broad-spectrum antiviral treatment that would be host-targeted, and directly delivered into the lungs.
In May 2021, Synairgen announced the results from the home cohort of its SG016 Phase II clinical trial of SNG001 in Covid-19 patients. In this trial, the therapy showed a drop in the hospitalisation rate in patients.
