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Synairgen fast-tracks trial of Covid-19 vaccine
StockMarketWire.com
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Synairgen is speeding up its Phase III trial design evaluating SNG001 as a treatment for patients with Covid-19.
Following discussions with the regulatory agencies it has made changes to its Phase III trial known as SG018.
It has removed the lower dose arm, thereby reducing the number of patients required to complete the placebo-controlled trial from 900 patients to 610 patients.
It has also made changes to primary endpoints which 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.
The company has also agreed to the addition of assessments for Long Covid-19 symptoms on day 60 and day 90. Dosing at trial sites for SG018 s is expected to commence imminently.
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.
The SG016 home trial which 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 is recruiting patients for trials.
At 9:49am: (LON:SNG) Synairgen PLC share price was 0p at 120p
Story provided by StockMarketWire.com
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