Synairgen this week raised £80mln to fund a Phase III trial for its candidate SNG001 in COVID-19 disease, which is due to commence in this quarter.
The trial will be run globally by Parexel with results expected in second-quarter 2021. The £80mln raised has also been earmarked to scale up manufacturing said the broker.
The trial follows a successful pre-IND meeting with the FDA, which provided the guidance to commence such a study, added finnCap.
“Assuming that this trial replicates the results seen in the 100-patient Phase II trial, we would expect Emergency Use Approval (EUA) to follow shortly thereafter.
“Meanwhile, the Managed Access Programme (MAP) in the UK and Europe, run by Clinigen, could generate early commercial revenues.”
Richard Marsden, CEO, Synairgen, commented: "It was particularly pleasing to see the level of support received for this financing, reinforcing confidence in SNG001, our wholly-owned drug and potential breakthrough treatment for COVID-19 patients.
"finnCap has always been supportive and built a good register of institutions in March which was broadened further in this funding.
“Having demonstrated the great promise of SNG001 in hospitalised COVID-19 patients earlier this year, we now have the resources to be able to rapidly progress this potential breakthrough treatment in such a critical area of unmet need."
FinnCap added this latest round will mean it has raised a total of £94mln for Synairgen since April, including a £14m fundraise to progress its candidate into Phase II trials.
The Phase II trial of hospitalised COVID-19 patients showed that SNG001 reduced odds of developing severe disease, increased likelihood of recovery and reduced breathlessness.
Geoff Nash, finnCap’s Corporate Finance Director, Life Sciences added: “We are extremely proud of what Synairgen has achieved, especially over the last eight months.
“We have always been strong believers in the value of SNG001 and delighted to have generated so much interest and support for this great success story of British biotech. “