RE: Rns Out!BOOM18 Dec 2020 07:11
Press release
Synairgen plc
('Synairgen' or the 'Company')
COVID-19 Clinical Programme Update
- SNG001 given Fast Track designation and IND cleared by the US FDA
- Phase III trial design adapted which will expedite results
- Phase III trial to commence dosing in UK imminently
Southampton, UK - 18 December 2020: Synairgen plc (LSE: SNG), the respiratory drug discovery and development company, today announces updates to the Company's Phase III trial design evaluating SNG001 as a treatment for patients with COVID-19 and positive progress on the regulatory path.
Update to Phase III trial (SG018) protocol in COVID-19 patients
Following discussions with the regulatory agencies, the trial has been amended as follows:
· Removal of the lower dose arm, thereby reducing the number of patients required to complete the placebo-controlled trial from 900 patients to 610 patients
· Addition of a second primary endpoint. The primary endpoints are now 'time to hospital discharge' and 'time to recovery'. The primary assessment of efficacy will be supported by the key secondary endpoint of 'progression to severe disease or death' and other secondary endpoints. Both primary endpoints have at least 90% power to detect a statistically significant effect of SNG001 compared to placebo
· Addition of assessments for Long COVID-19 symptoms on day 60 and day 90
Initiation of the first SG018 sites has commenced in the UK, with dosing expected to commence imminently. The SG018 trial was deemed an Urgent Public Health study and recognised as a National Priority by the National Institute for Health Research (NIHR) in October 2020.
Investigational New Drug clearance and Expedited Regulatory Pathway granted from the FDA
Synairgen's Investigational New Drug (IND) application to the FDA to evaluate SNG001 as a treatment for patients with COVID-19, has been cleared, enabling Synairgen to initiate its SG018 trial in the US. Furthermore, the FDA has awarded SNG001 Fast Track status, enhancing the ability of Synairgen to interact with the FDA and shortening review timelines.
Update on the SG016 home trial in COVID-19 patients
This trial targets patients with a positive SARS-CoV-2 test result who are aged over 65 and those over the age of 50 with 'high risk' medical conditions. It is a trial designed to make it easy and safe for trial participants and researchers to conduct the research; all supplies for the trial are delivered directly to the patient's door by courier, and all trial visits and assessments are conducted virtually by video call. After a slow start in the summer, recruitment and dosing are now progressing well with a noticeable increase in the last two months. Those interested in participating in the trial can visit www.covidtrialathome.com.
Richard Marsden, CEO of Synairgen, said: "With this adaptation we should be able to reduce the time taken to complete the trial, which, together with an expedited rev