Results from a phase 1 trial of Synairgen’s lead COVID-19 candidate SNG001 demonstrated a significant reduction in the risk of developing severe disease compared to placebo.
The preliminary positive results are good news for the Southampton, UK-based biotech company, and come only four months after Synairgen announced the Medicines and Healthcare products Regulatory Agency (MHRA) and Health Research Authority (HRA) approved the trial.
The double-blind, placebo-controlled phase 1 trial of SNG001 recruited 101 hospitalised COVID-19 patients from nine hospital sites across the UK. Synairgen found that treatment with its drug resulted in a 79% lower risk of developing severe disease compare to the control arm.
Patients who received SNG001 were also more than twice as likely to recover, defined by ‘no limitation of activities’ or ‘no clinical or virological evidence of infection’, over the course of the treatment compared to those taking the placebo. While three patients died after being randomised to receive the placebo, no deaths were observed among those treated with SNG001.
However, for patients with more severe disease presentation at the time of admission, SNG001 treatment didn’t significantly reduce the duration of their hospital stay, although it did increase the likelihood of hospital discharge during the study.
SNG001 delivers an inhaled formulation of Interferon-beta-1a (INF-beta-1a) to the lungs directly via nebulisation and has previously been tested in phase 2 trials in asthma.
INF-beta is a naturally occurring protein that controls the body’s antiviral response, and previous research has found that a lack of INF-beta production in the lungs can be linked to an increased susceptibility to develop severe respiratory symptoms as a result of viral infections.
“We are delighted with the positive data produced from this trial, which is the result of a momentous coordinated effort from Synairgen, the University of Southampton, University Hospital Southampton NHS Foundation Trust and the highly expert research teams across the NIHR network and regulatory bodies in the UK,” said Tom Wilkinson, professor of respiratory medicine at the University of Southampton and chief investigator of the trial.
“The results confirm our belief that interferon-beta, a widely known drug that, by injection, has been approved for use in a number of other indications, has huge potential as an inhaled drug to be able to restore the lung’s immune response, enhancing protection, accelerating recovery and countering the impact of SARS-CoV-2 virus,” he added.
Now that SNG001 has produced promising results in the early-stage study, wide-scale confirmatory trials will be needed to determine if the drug can maintain its robust efficacy against COVID-19.