(Alliance News) - Synairgen PLC on Friday said its Covid-19 treatment SNG001 has been given a fast track designation by the US Food and Drug Administration.
This has enabled the respiratory drug discovery and development company based in Southampton to initiate its phase III SG018 trial in the US and shorten its review times with the FDA. Dosing is expected to start imminently in the UK, it said.
Shares in Synairgen were up 37% at 148.75 pence in London on Friday.
Synairgen said its SG018 trial has been amended with regulatory agencies and is making positive progress. 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", changed primary endpoints to 'time to hospital discharge' and 'time to recovery', and added assessments for Long Covid-19 symptoms, where patients are unable to shake off the effects of the virus months after initially falling ill, on day 60 and 90.
Chief Executive Richard Marsden said: "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. With trial sites now being set up, we anticipate dosing the first patients imminently."
In November, Synairgen reported SNG001 was shown to be "well tolerated", and patients who received the drug had greater odds of improvement and recovered more rapidly from the coronavirus.
By Zoe Wickens; zoewickens@alliancenews.com
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Synairgen (SNG)