Synairgen announces inclusion of its inhaled interferon beta treatment in US NIH ACTIV-2 trial in COVID-19 outpatients - Seite 3

SNG001 (inhaled Interferon beta) applicability to COVID-19

Interferon beta ('IFN-beta') is a naturally occurring protein, which orchestrates the body's antiviral responses. It is used widely systemically for the treatment of multiple sclerosis and is a safe and well tolerated drug. There is growing evidence that deficiency in IFN-beta production by the lung could explain the enhanced susceptibility in 'at-risk' patient groups to developing severe lower respiratory tract (lung) disease during respiratory viral infections. Furthermore, viruses, including coronaviruses especially SARS-CoV-2, have evolved multiple mechanisms for suppressing endogenous IFN-beta production in the lung thereby helping the virus to evade the innate immune system. The addition of exogenous IFN-beta before or during viral infection of lung cells in vitro either prevents or greatly reduces viral replication to reduce the severity of infection and accelerate recovery. Recognising the importance of achieving high concentrations in the lung where SARS-CoV-2 exerts most of its tissue damaging effects, Synairgen's SNG001 is a formulation of IFN-beta-1a for direct delivery to the lungs via nebulisation. It is pH neutral, and is free of mannitol, arginine and human serum albumin, making it suitable for inhaled delivery direct to the site of action. Phase I and II trial data have shown that SNG001 activates lung antiviral defences as measured in sputum cells, and that SNG001 has been well tolerated in approximately 280 asthma/COPD/COVID-19 patients to-date.

In July 2020, Synairgen announced the results of its Phase II double-blind, placebo-controlled study of 101 randomised COVID-19 hospitalised patients, which showed that SNG001 given for 14 days, was associated with greater odds of improvement versus placebo on the WHO Ordinal Scale for Clinical Improvement and more rapid recovery to the point where patients were no longer limited in their activity, with a greater proportion of patients recovering during the 28-day study period.

The results were published in The Lancet Respiratory Medicine: "Safety and efficacy of inhaled nebulised interferon beta-1a (SNG001) for treatment of SARS-CoV-2 infection: a randomised, double-blind, placebo-controlled, phase 2 trial". Monk, P D et al., 12 November 2020, accessible here: https://www.thelancet.com/journals/lanres/article/PIIS2213-2600(20)305 ....

On 20 January 2021, Synairgen announced that it had completed recruitment of 120 COVID-19 patients (over the age of 65, or those over 50 with a comorbidity) in the home setting for its SG016 trial. Results from this study are expected in Q2 2021.