Synairgen’s SNG001 advances into phase 3 COVID-19 trial

Southampton, UK-based biotech company Synairgen has announced that a small phase 2 trial of its investigational candidate SNG001 supports advancement into phase 3 testing.

SNG001 delivers an inhaled formulation of Interferon-beta-1a (INF-beta-1a) to the lungs directly via nebulisation – INF-beta is a naturally occurring protein that controls the body’s antiviral response.

Initially, Synairgen had been evaluating the drug as a treatment for COPD and asthma, although its focus has now shifted to investigating SNG001’s potential in COVID-19 patients.

In a 101-patient phase 2 study of SNG001, of which 48 were given the drug and 50 a placebo each day, patients receiving the INF-beta-1a candidate had ‘greater odds of improvement’ on the World Health Organization’s (WHO) Ordinal Scale for Clinical Improvement (OSCI) on day 15 or 16.

In addition, patients receiving SNG001 treatment were more likely than those receiving placebo to recover to an OSCI score of 1 during treatment – characterised as ‘no limitation of activities’.

The findings, published in The Lancet, also found that over the 14-day treatment period, patients in the SNG001 group were more than twice as likely to recover compared to those in the placebo group.

Further, 58% of the patients in the SNG001 group had recovered on day 28, compared to 35% in the placebo group.

However, there was no significant difference between the treatment groups in terms of hospital discharge or time to hospital discharge, the study found.

Still, the findings from this study support further exploration of SNG001 in COVID-19, with the treatment now progressing to a phase 3 trial, the researchers added.

“The results confirm our belief that interferon beta, a widely known drug approved for use in its injectable form for other indications, may have the potential as an inhaled drug to restore the lung’s immune response and accelerate recovery from COVID-19,” said Tom Wilkinson, professor of respiratory medicine at the University of Southampton and lead author of the study.

“This pH neutral, inhaled interferon beta-1a formulation (SNG001) provides high, local concentrations of the immune protein which boosts lung defences rather than targeting specific viral mechanisms.

“This might carry additional advantages of treating COVID19 when it occurs alongside infection by another respiratory virus such as influenza or Respiratory Syncytial Virus that may well be encountered in the winter months,” he added.