Phase 2 data hints the immune response-modulating therapy could play a role in burdened hospital settings.
Inhaled nebulized interferon beta-1a (SNG0001) is associated with greater odds of improvement and rapid recovery among patients infected with SARS-CoV-2, according to findings from a new randomized, double-blind, placebo-controlled phase 2 trial.
In new data published in The Lancet Respiratory Medicine and reported by a UK team of investigators, the immune response-modulating interferon—which has been previously assessed for coronaviruses in vitro—was shown to benefit patients hospitalized with coronavirus 2019 (COVID-19).
Led by Phillip D. Monk, of the Southampton General Hospital, investigators sought assessment of interferon beta-1a for severe COVID-19 due to its promising portfolio and the fact that infected hosts for novel virus strains are generally dependent on innate immune responses in order to limit the severity of illness.
“Essential to this innate response is the action of interferons, key orchestrators of the antiviral immune response with both potent antiviral and immunomodulatory functions,” Monk said.
What’s more, at-risk severe COVID-19 populations—including older, comorbid, or immunosuppressed patients—produce less interferon-beta.
Monk and colleagues assessed the efficacy and safety of inhaled nebulized interferon beta-1a for treating hospitalized COVID-19 patients in the UK. Their trial included patients aged 18 years and older admitted to 1 of 9 hospitals with a positive RT-PCR or point-of-care test for SARS-CoV-2.
Patients were randomized 1:1 to either SNG001 6 MIU, or inhaled placebo via mouthpiece daily for 14 days. They sought a primary efficacy outcome of change in clinical condition on the World Health Organization (WHO) Ordinal Scale for Clinical Improvement (OSCI) during the dosing period in the treatment arm.
The ordinal scale is a nine-point metric in which 0 represents no infection in a patient, and 8 represents patient death from the virus. Investigators conducted multiple analyses to identify the most suitable statistical method for future clinical trials, as this was only a phase 2 assessment.
Investigators additionally assessed for adverse events from 28 days after baseline.
The team randomly assigned 101 patients to either SNG001 (n = 50) or placebo (n = 51) from March 30 to May 30 this year. The intent-to-treat population included 48 SNG001 patients and 50 placebo patients.
At baseline, 67% of patients required oxygen supplementation, 37% of whom were in the SNG001 group.
At day 15-16, patients receiving SNG001 had more than two-fold greater odds of improving on the OSCI scale (odds ratio [OR], 2.32; 95% CI, 1.07 – 5.04; P = .033) than patients on placebo, and were also far more likely to achieve an OSCI score of 1—indicating no limitation of activities necessary—during treatment (hazard ratio [HR], 2.19; 95% CI, 1.03 – 4.69; P = .043).
Monk and colleagues observed a good tolerance of SNG001 among treated patients, with the most common treatment-emergent adverse events being headache (15%). Three patient deaths were reported in the placebo group, and none in the SNG0001 group.
Though investigators believe a phase 3 assessment would be warranted to confirm their findings, they did suggest there may be utility of interferon beta-1a in hospitalized COVID-19 care going forward.
“Currently, treatment options for COVID-19 remain limited, with the only evidence-based therapies being remdesivir and dexamethasone,” investigators wrote. “Despite the use of these therapies, clinical outcomes remain poor.”
They added that, with the second peak of new COVID-19 cases and rising hospitalization rates, the investigative therapy may play a particularly beneficial role in the northern hemisphere, where the winter incidence of cold and influenza could compound the burden of the pandemic.
“The development of broad-spectrum antiviral agents, such as interferon-β, that boost local lung defenses rather than targeting specific viral mechanisms, might carry substantial additional benefits to patients and to overburdened health-care systems alike,” they wrote. “This will also require investigation.”