Shares in respiratory and drug discovery company Synairgen (SNG:AIM) surged 36% to 148.3p on Friday after it received fast track status from the US FDA (Food and Drug Administration).
This means shorter review timelines from the FDA and comes after the company made an Investigational New Drug (IND) application for its SNG001 inhaled drug as a treatment for patients with Covid-19, enabling the start of US trials.
‘With this adaptation we should be able to reduce the time taken to complete the trial, which, together with an expedited review from the FDA, could allow us to get this therapy approved for patient use in Covid-19 more rapidly’, said chief executive Richard Marsden.
STAGE THREE TRIAL UPDATE
After discussions with regulators the late stage three trial (last before applying for approvals) has been redesigned so that fewer patients are required, which should speed up the process. The company has also added assessments for long Covid symptoms in day 60 and day 90.
The company said an ongoing UK home trial of Covid-19 patients over the age of 65 and those over 50 with pre-existing medical conditions was progressing well with recruitment and dosing seeing a ‘noticeable increase in the last two months.’
Numis commented, ‘with new strains/mutations emerging, and SARS-CoV-2 likely now endemic, the need for SNG001 remains significant.’
