Synairgen said that the first patient has been dosed in the Phase 3 SG018 trial of its SNG001 inhaled interferon beta-1a in hospitalized COVID-19 patients, with the SG018 study expected to enroll 610 COVID-19 patients at sites in 20 countries. A Phase 2 study of SNG001 in non-hospitalized patients is also underway, the company said.
In July 2020, Synairgen announced positive results from a Phase 2 trial of SNG001 in hospitalized COVID-19 patients, and in November 2020, the company said that it would collaborate with Paraxel Biotech to conduct the SG018 trial.
Synairgen CEO Richard Marsden said, “We need treatments as well as vaccines to fight highly pathogenic viruses such as SARS-CoV-2. Development of treatments like ours will remain necessary in cases where vaccines are not effective, for those who do not get vaccinated, and in case the virus mutates to the point where vaccines become less effective. We believe this trial presents an opportunity for a significant UK scientific breakthrough and, if given the right support, our drug could rapidly assist with the global crisis.”
The company noted that SNG001 has been granted Fast Track status by the FDA and has been designated as an Urgent Public Health study by the UK National Institute for Health Research (NIHR). Synairgen added that it is seeking priority status for SNG001 in additional countries as well.
Read the Synairgen press release.