Inhaled agent under investigation for COVID-19 

Inhaled interferon beta-1a did not meet its primary endpoint in patients who were hospitalised with COVID-19 but may improve clinical outcomes in patients with more severe disease or risk factors for disease progression, subgroup analyses of the SPRINTER trial displayed. Suggested is to evaluate inhaled interferon beta-1a in patients with severe viral lung infections in general, and in hospitalised patients with COVID-19 that have a more severe disease in particular.

“Inhaled interferon beta-1a has demonstrated anti-viral activity against a range of respiratory viruses, including SARS-CoV-2,” outlined Prof. Tom Wilkinson (University of Southampton, UK) [1]. Moreover, inhaled delivery optimises the exposure of this agent to the tissue it should target, without ample systemic exposure [2,3]. Positive phase 2 results of this agent in COVID-19 [4] led to the unfoldment of the phase 3 SPRINTER trial (NCT04732949). The trial randomised 623 patients who were hospitalised with moderate COVID-19 1:1 to a 14-day course of inhaled interferon beta-1a plus standard care or placebo plus standard care. The primary endpoints were the time to hospital discharge and the time to recovery to ‘no limitations of activities’ up to day 28.

No difference was observed in time to hospital discharge between the 2 arms of the study (HR 1.06; 95% CI 0.89‒1.27; P=0.509). Key secondary endpoints did not demonstrate a benefit of inhaled interferon beta-1a over placebo either but trended towards a benefit for the intervention arm: progression to severe disease or death (interferon beta-1a 10.7% vs placebo 14.4%; OR 0.71; P=0.161). Furthermore, in patients with O₂ saturation ≤92% or respiratory rates ≥21 breaths per minute, the per-protocol analysis did show a trend towards a reduced risk of severe disease or death in those who were treated with inhaled interferon beta-1a instead of placebo (3.4% vs 12%; P=0.046).

The safety profile of inhaled interferon beta-1a was favourable and consistent with previously reported data. The rates of serious treatment-emergent adverse events were 12.6% and 18.2% in the experimental arm and placebo arm, respectively.

Prof. Wilkinson concluded that the favourable trends for inhaled interferon beta-1a over placebo that were observed in the current trial provide a clinical rationale to investigate the effect of this agent on the endpoint of progression of disease or mortality in hospitalised patients with COVID-19 and in patients with severe viral lung infections.

1. Wilkinson TMA, et al. SPRINTER: A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Trial to Determine the Efficacy and Safety of Inhaled Interferon Beta-1a (SNG001) for the Treatment of Patients Hospitalised Due to COVID-19. ALERT 3, RCT2884, ERS International Congress 2022, Barcelona, Spain, 4–6 September.
2. Djukanović R, et al. Am J Respir Crit Care Med. 2014;190(2):145‒54.
3. Filipi ML, et al. Int J MS Care. 2014;16(1):55–60.
4. Monk PD, et al. Lancet Respir Med. 2021;9(2):196‒206.

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Posted on 30 October 202215 February 2024