Synairgen has announced that a Phase 2 clinical trial of its SNG001 nebulized interferon-beta-1a demonstrated that hospitalized COVID-19 patients receiving the drug were two times more likely to recover over the course of treatment; had significantly less dyspnea; and had a 79% lower risk of requiring ventilation and/or dying than patients receiving a a placebo.
The company had announced plans for the double blind, placebo controlled trial in March 2020. The study enrolled 101 patients in UK hospitals from the end of March to the end of May, with an average age of 56.5 years in the placebo group and 57.8 years in the SNG001 group. In the placebo group, median time to discharge was 9 days; in the SNG001 group, it was 6 days. Three patients in the placebo group died, while none in the SNG001 group died.
Synairgen CEO Richard Marsden commented, “We are all delighted with the trial results announced today, which showed that SNG001 greatly reduced the number of hospitalized COVID-19 patients who progressed from ‘requiring oxygen’ to ‘requiring ventilation.’ It also showed that patients who received SNG001 were at least twice as likely to recover to the point where their everyday activities were not compromised through having been infected by SARS-CoV-2. In addition, SNG001 has significantly reduced breathlessness, one of the main symptoms of severe COVID-19. This assessment of SNG001 in COVID-19 patients could signal a major breakthrough in the treatment of hospitalized COVID-19 patients. Our efforts are now focused on working with the regulators and other key groups to progress this potential COVID-19 treatment as rapidly as possible.”
Company co-founder Stephen Holgate, Clinical Professor of Immunopharmacology at the University of Southampton, added, “Recognizing that SARS-CoV-2 is known to have evolved to evade the initial antiviral response of the lung, our inhaled treatment of giving high local concentrations of interferon beta, a naturally occurring antiviral protein, restores the lung’s ability to neutralize the virus, or any mutation of the virus or co-infection with another respiratory virus such as influenza or RSV, as could be encountered in the winter if there is a resurgence of COVID-19.”
In 2014, AstraZeneca licensed SNG001 for the treatment of viral respiratory infections in asthma, but the Phase 2a INEXAS trial was halted due to questions about the trial design, and AstraZeneca returned the rights in 2017. Synairgen had previously announced positive results from a Phase 2 study demonstrating that SNG001 produced statistically significant improvement in asthma patients suffering from a cold compared to placebo.
After the failure of the development program for asthma, Synairgen began development of SNG001 for respiratory infections in COPD patients. A Phase 2 trial of SNG001 for respiratory infections in COPD was paused due to the pandemic.
Read the Synairgen press release.
