Interferon beta-1a candidate for COPD advances to PhIII to test its potential against Covid-19
Another repurposed drug is entering Phase III to see if it passes the test against Covid-19.
In a small Phase II trial, Synairgen says hospitalized Covid-19 patients who took its inhalable interferon beta-1a formulation, SNG001, were twice as likely to recover within 14 days than patients on a placebo. CEO Richard Marsden said the Southampton, UK-based biotech is launching the candidate — which was already in development for COPD and asthma — into a 900-person Phase III study in the coming weeks.
The Phase II trial began in March and was carried out at 9 UK hospitals. A total of 48 patients were given SNG001 and 50 a placebo daily for up to 14 days. Synairgen followed up for a maximum of 28 days after starting treatment, and conducted several analyses using the World Health Organization’s Ordinal Scale for Clinical Improvement. While statistical significance was only achieved in some of the analyses, Marsden said the results were enough to justify progressing the candidate into Phase III.
“Some of them happen so infrequently,” Marsden said of the analyses. “So things like death — there were only three deaths in the trial. They were all on placebo, so we didn’t analyze that because it’s too small to analyze. Going onto ventilators was quite a rare event, so that one didn’t reach statistical significance, although it was numerically in favor of (the) drug.”
SNG001 achieved statistical significance in preventing patients from worsening to need non-invasive ventilation or high-flow oxygen in a first analysis, but just missed the mark in a second more conservative analysis, Marsden said. But what the company has become most interested in is time to full recovery.
For the purposes of the study, Synairgen defined “full recovery” as the point where a patient no longer experiences limitations in everyday activities. By that measure, 21 patients (44%) in the treatment arm reached full recovery over the 14-day treatment course, versus 11 (22%) in the placebo group.
“The thing that we’re most excited about is getting people back to this level of no limitation of activities, and you’re more than twice as likely — approaching three times as likely in some of the analyses — of getting back to that level if you’re on drug compared to placebo,” Marsden said.
According to results published in the Lancet, 6 patients on the interferon beta-1a formulation (13%) developed severe disease, compared to 11 (22%) in the placebo group.
Nathan Peiffer-Smadja, a lead author who wasn’t involved in the study, wrote in a comment: “The number of patients enrolled in this pilot clinical trial is of course small. In addition, this study neither showed any impact of the evaluated treatment on time to discharge nor on mortality, although the study was obviously not powered to respond to the latter question. Larger randomised clinical trials are therefore needed to confirm these results.”
So why the small trial size? It’s what the WHO recommended back in January, Marsden said. Plus, “we didn’t have enough drug to do more patients,” he added.
“So, that was us putting … our chips on the table and seeing if the drug could do something helpful. And I think what was very interesting (was) that during Q2 and Q3 this year, there’s been a mounting in literature which suggests that this virus is suppressing the production of interferon beta as part of its strategy to evade the immune system,” he said.
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