Synairgen has announced that the Phase 2 ACTIV-2 trial of SNG001 inhaled interferon-beta-1a in non-hospitalized COVID-19 patients failed to show a statistically significant reduction in hospitalization, viral load, safety, or resolution of symptoms compared to placebo, but the study did demonstrate a relative reduction of 86% in hospitalization. Over the course of the trial, which was sponsored by the National Institutes of Health (NIH), 1 patient out of 110 in the SNG001 group was hospitalized at day 28 compared to 7 out of 110 in the placebo group, the company said.
In October 2021, Synairgen announced that the the external data safety monitoring board (DSMB) for ACTIV-2 had recommended advancing SNG001 into a Phase 3 trial in non-hospitalized patients; the company said that it did not have any data from ACTIV-2 at that time. According to Synairgen, recruitment for the trial was halted in March 2022 by the NIH.
A previous Phase 2 trial conducted in hospitalized patients early in the pandemic had demonstrated significant benefits for patients treated with SNG001 compared to placebo, and the Phase 3 SPRINTER trial of SNG001 in hospitalized COVID-19 patients was initiated in January 2021. Synairgen recently said that it would soon present data from the SPRINTER trial demonstrating that the nebulized IFN-β1a may reduce long COVID symptoms.
Synairgen CEO Richard Marsden commented, “The data from the ACTIV-2 trial in the US showing a non-significant but encouraging 86% relative risk reduction in hospitalization following treatment with SNG001 in home-based patients are very interesting when considered in the context of therapeutic options for the management of non-hospitalized patients during a pandemic. These results are really encouraging and build upon the strong body of non-clinical and clinical evidence, which includes Synairgen’s home-based trial (SG016) in high-risk patients, supporting SNG001’s potential as a broad-spectrum antiviral for a wide range of severe lung infections including COVID-19. We will now begin to evaluate the full data set and factor these findings into our development plans.”
The company said that it “continues to actively pursue and refine multiple clinical approaches including company- and investigator-sponsored studies and possibly platform studies (as and when appropriate), to confirm the most expeditious clinical development path for SNG001 in patients hospitalized due to a severe viral lung infection including SARS-CoV-2, influenza, RSV, adenovirus, parainfluenza and rhinoviruses.” SNG001 has also been in development for the treatment of asthma and COPD.
Read the Synairgen press release.
