Synairgen's inhaled interferon beta cuts chance of developing severe COVID-19 disease

Synairgen announced Monday that its inhaled formulation of interferon beta, dubbed SNG001, significantly reduced the chance of developing severe disease compared to placebo in hospitalised COVID-19 patients. Chief study investigator Tom Wilkinson remarked "the results confirm our belief that interferon beta…has huge potential as an inhaled drug to be able to restore the lung's immune response, enhancing protection, accelerating recovery and countering the impact of SARS-CoV-2 virus."

The SG016 trial included 101 patients who were admitted to hospital due to the severity of their confirmed or suspected COVID-19 disease, as well as 120 subjects in the home setting. Participants were randomised to receive SNG001 or placebo delivered by mesh nebuliser once-a-day for up to 14 days. The study's primary endpoint was change in condition measured using the Ordinal Scale for Clinical Improvement during the dosing period.

Breathlessness "markedly reduced"

According to Synairgen, results showed that the odds of developing severe disease during the treatment period were cut by 79% for hospitalised patients receiving SNG001 compared to those given placebo. In addition, patients who received SNG001 were more than twice as likely to recover over the course of the treatment period versus those in the placebo group. The company added that over the treatment period, the measure of breathlessness was "markedly reduced" in patients who received SNG001 compared to those given placebo.

Meanwhile, Synairgen said that in patients with more severe disease at the time of admission, treatment with SNG001 increased the likelihood of hospital discharge, although the difference was not significant. The drugmaker noted that the median time to discharge was 6 days for patients treated with SNG001 and 9 days for those receiving placebo. In addition, while patients in the SNG001 group appeared to be more than twice as likely to have recovered by the end of the treatment period, the difference did not reach significance. Results also showed that by day 28, patients receiving SNG001 had significantly better odds of recovery.

The company, whose shares more than tripled on the findings, noted that three patients died after being randomised to placebo, while no deaths were reported in those given SNG001. Wilkinson commented that while the trial was relatively small, the signal that SNG001 benefits patients was unusually strong. Wilkinson added that if the results are confirmed in larger studies the treatment will be "a game changer."

Regulatory discussions up next

"We couldn't have expected much better results than these," remarked Synairgen chief executive Richard Marsden, adding "our efforts are now focused on working with the regulators and other key groups to progress this potential COVID-19 treatment as rapidly as possible." Marsden explained that the company will talk with regulators in the next couple of days to see what additional data are needed in order to seek approval. The executive suggested that Synairgen expects to be able to deliver "a few 100,000" doses of SNG001 a month by the winter.

Commenting on the news, finnCap analyst Mark Brewer said what happens next will depend on the "upcoming discussions with regulators, which should clarify the route to market and the potential for buying SNG001 ahead of the winter 2020 flu season and the possibility of a second wave of COVID-19." Brewer added that quantifying the coronavirus opportunity for Synairgen was "nigh on impossible."

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