The UK Medicines and Healthcare products Regulatory Agency (MHRA) and Health Research Authority (HRA) have expedited approvals for a Phase 2 trial of Synairgen’s SNG001 nebulized interferon-beta-1a for the treatment of COVID-19, the company said. According to the company, coronaviruses like SARS-CoV-2 have the ability to interfere with production of endogenous interferon-beta. The double blind, placebo controlled COVID-19 trial is expected to enroll 100 COVID-19 patients in the UK.
SNG001 has been in development for the treatment of respiratory infections in COPD patients after failing to advance in development for the treatment of viral respiratory infections in severe asthma patients. In 2012, Synairgen announced positive results from a Phase 2 study demonstrating that SNG001 produced statistically significant improvement compared to placebo in asthma patients suffering from a cold. In 2014, AstraZeneca licensed SNG001 but stopped the Phase 2a INEXAS trial of SNG 001 for viral respiratory infections in asthma patients due to questions about the trial design.
According to the company, an ongoing Phase 2 trial of SNG001 for the treatment of respiratory infections in COPD patients has been paused due to the COVID-19 pandemic after 109 of 120 participants had been dosed.
Synairgen CEO Richard Marsden said, “We have worked intensively with the relevant authorities and collaborators to enable SNG001 to be assessed in COVID-19 patients. SNG001 has been well tolerated in clinical trials in over 200 respiratory patients to date and has accelerated lung function recovery in two Phase 2 asthma trials in patients with a cold or flu infection. A successful outcome from this trial in COVID-19 patients would be a major breakthrough in the fight against this coronavirus pandemic.”
Read the Synairgen press release.
