Synairgen PLC (AIM:SNG, OTC:SYGGF, FRA:OMY) said the Phase III trial of its SNG001 inhaled, broad-spectrum antiviral is progressing well and it expects to enrol the last patient in November. Top line results are expected in early 2022.
In a statement alongside interim results, Synairgen said its clinical trial team, working alongside clinical research organization Parexel, has gained trial approvals in 17 countries and initiated over 100 trial sites despite the challenges posed by Coronavirus (COVID-19)-related restrictions. SNG001 is designed to treat COVID-19 amongst other conditions.
Since the first patients were recruited in January 2021 in the UK, the trial is approaching 80% enrolment of patients out of the targeted 610 and top line results are now expected in early 2022.
SNG001 is seen as having potential value not only for COVID-19 patients hospitalised due to severe lower respiratory tract symptoms, but also for government stockpiling for future pandemic preparedness and other severe viral lung infections caused by cold and flu viruses.
“Positive data from this trial would represent a major breakthrough in the battle against COVID-19,” said Synairgen’s chief executive Richard Marsden.
With the aim of getting the treatment to patients as quickly as possible, he said the company is preparing to engage with the US medical regulator, the Food & Drug Administration on a potential application for Emergency Use Authorisation (EUA) and has already agreed partners with COVID-19 expertise for distribution and in-market support.
Marsden said there remains an urgent ongoing need for an effective, broad-spectrum antiviral to treat patients hospitalised due to COVID-19.
“While vaccines have played an important role in reducing many of the risks associated with the SARS-CoV-2 virus, thousands of patients continue to require hospital treatment in the US and Europe every day with acute symptoms from COVID-19. This, coupled with the potential of waning immunity and the emergence of new SARS-CoV-2 variants, highlights the urgent need for additional effective antiviral therapies.”
Outside the trial, there is also further testing of antiviral activity of IFN-beta against key COVID-19 variants, the ongoing US government funded ACTIV-2 trial evaluating SNG001 on patients with mild to moderate COVID-19 symptoms in the home setting, as well as the continued build-out of distribution, pre-commercialisation and commercialisation capabilities.
Synairgen had cash balances of £46.2mln at the end of June, after £36.9mln was spent on research and development in the first six months of the year to advance the clinical trial and scale-up its manufacturing activities.
Along with just under £2mln administrative expenses, offset by £1.1mln of R&D tax credits, the company made a loss before tax of £38.9mln.