A U.K. biotech has seen its shares skyrocket on new data from its experimental treatment in hospitalized COVID-19 patients, but it’s too early for game-changer cliches. .
The data from Synairgen's drug, the inhaled formulation of interferon beta known as SNG001, come from a double-blind placebo-controlled trial that recruited 101 patients from nine specialist hospital sites in the U.K. during the peak of the virus’s grip on the country from March through May.
The data showed those who were given SNG001 had a 79% lower risk of developing severe disease compared to placebo, according to the biotech, with patients who got that drug also more than twice as likely to recover from COVID-19 than those on a dummy med.
Patient groups were evenly matched in terms of average age (56.5 years for placebo and 57.8 years for SNG001), comorbidities and average duration of COVID-19 symptoms prior to enrollment (9.8 days for placebo and 9.6 days for SNG001).
The early data look like this: The odds of developing severe disease (e.g., requiring ventilation or resulting in death) during the treatment period (day 1 to day 16) were reduced by 79% for patients receiving SNG001 compared to placebo, although the p-value at 0.046 was very, very close to not being statistically significant.
And on a second metric, where SNG001 patients were more than twice as likely to recover (defined by the company as "no limitation of activities" or "no clinical or virological evidence of infection") over the course of the treatment period compared to those receiving placebo, this again was very close to not being significant, with a p-value of 0.043.
It also found the measure of breathlessness was “markedly reduced” in patients who received SNG001 compared to those receiving placebo (where p=0.007), and while three subjects (6%) died after being randomized to placebo, there were no deaths in the SNG001 group.
In the patients with more severe disease at time of admission (i.e. requiring treatment with supplemental oxygen), SNG001 treatment increased the likelihood of hospital discharge during the study, but the difference was not statistically significant, where p=0.096.
The median time to discharge was six days for patients treated with SNG001 and nine days for those receiving placebo.
It also found that patients receiving SNG001 “appeared to be more than twice as likely to have recovered by the end of the treatment period,” but again this was not statistically significant, with p=0.062.
“However by day 28, patients receiving SNG001 treatment had statistically significantly better odds of recovery," (where p=0.017), the biotech said.
“Interestingly, the efficacy analyses indicate there is no evidence of an association between the SNG001 positive treatment effects and prior duration of COVID-19 symptoms,” the biotech, which spun out of Southampton University in Southern England, added in a release.
“Further analysis will be conducted over the coming weeks and reported in due course.” It has not been published in a peer-reviewed journal, and, without full data, there are still many caveats as to how well this helped patients.
Interferon beta is produced when host cells get a viral infection; Synairgen uses this protein in an inhaled formulation, which means it passes directly into the lungs of patients with coronavirus using a nebulizer in the hope it will stimulate an immune response.
The drug had once been partnered through U.K. Big Pharma AstraZeneca, but a failed midstage test in asthma patients three years ago saw it cut that deal loose, returning rights back to the biotech.
Richard Marsden, CEO of Synairgen, said: “We are all delighted with the trial results announced today, which showed that SNG001 greatly reduced the number of hospitalised COVID-19 patients who progressed from ‘requiring oxygen’ to ‘requiring ventilation.’ It also showed that patients who received SNG001 were at least twice as likely to recover to the point where their everyday activities were not compromised through having been infected by SARS-CoV-2.
“In addition, SNG001 has significantly reduced breathlessness, one of the main symptoms of severe COVID-19. This assessment of SNG001 in COVID-19 patients could signal a major breakthrough in the treatment of hospitalised COVID-19 patients. 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.”
Shares in the biotech soared 300% in early U.K. trading Monday morning on the news.