Researchers found that the new experimental version of interferon beta-1a from British biotech company Synairgen, reused to treat Covid-19, increased the chances of improvement and recovery in hospital patients from Covid-19 in a phase 2 trial.
SNG001 is an inhaled formulation of interferon beta-1a, typically used to decrease inflammation and reduce nerve damage caused by multiple sclerosis. In the trial, SNG001 was administered to 48 patients using a nebulizer while 50 patients received the placebo.
After two weeks, patients who received the daily treatment were twice as likely to improve by day 15 or 16 and more than three times as likely to improve by day 28 as those given placebo, found the researchers. However, “there was no significant difference between the treatment groups with respect to the odds of discharge from hospital or time to discharge from hospital,” the researchers wrote.
Overall, three patients died during the study and all were in the placebo group.
The researchers also found that 11 patients – or 22% – in the placebo group developed severe disease on day 16 compared to six patients – or 13% – in the SNG001 group.
The most common adverse event in the SNG001 group was headache.
“SNG001, a treatment already studied and shown to be well tolerated in patients with asthma and COPD, also appears to be well tolerated in patients admitted to hospital with COVID-19,” the researchers wrote. in the study. “These encouraging data provide a strong rationale for larger international studies in the context of the continuing clinical burden of COVID-19. ”
The study has limitations, including the fact that the number of patients in the study was small.
“It would take a phase 3 trial”
“There seems to be maybe a signal here, but we don’t know how much. There’s no evidence that it’s a dramatic signal, like a death signal necessarily, and it’s a small study. I think the authors of the article sums it up best when they say there should be a phase 3 trial, ”said Dr. Jay Finigan, pulmonologist and director of the Respiratory Centers of Excellence at National Jewish Health in Denver, who did not participate in the new study.
“Overall, we’re talking relatively small numbers and there’s no signal in terms of discharges or fatalities, although it’s definitely not powered for that,” he said.
Currently, the drug remdesivir is the only treatment approved by the US Food and Drug Administration for Covid-19. Certain other therapies – Eli Lilly’s antibody treatment and convalescent plasma – have received emergency use authorizations for the treatment of Covid-19. In addition, several experimental treatments are currently under study.
“There are definitely a lot of different drugs with different delivery mechanisms. There are other inhaled drugs that are being considered and investigated that target different areas, ”Finigan said.
“There are antiviral drugs, drugs that work on the immune system, antibodies, drugs that try to target inflammation and some of the inflammatory mediators,” he said. “Overall, unfortunately, the data that came out in this patient population were fairly broadly consistent in that none of them showed a benefit in mortality except for dexamethasone, a corticosteroid. .
Regarding SNG001, “larger randomized clinical trials” are needed, wrote Nathan Peiffer-Smadja and Yazdan Yazdanpanah, both of Bichat-Claude Bernard Hospital in Paris, in an editorial published alongside the new study. in The Lancet Respiratory Medicine.
“The safety of nebulized beta-1a interferon will be of particular interest since nebulized interferon does not yet have a marketing authorization for any indication,” wrote Peiffer-Smadja and Yazdanpanah.
“It will also be worth investigating whether interferon beta-1a has an impact on the prolonged symptoms of COVID-19, especially pulmonary symptoms,” they wrote. “To optimize the antiviral effect of interferon beta, there is greater justification for targeting patients at an early stage of the disease. “