Following discussions with the regulatory agencies, the trial – known as the SG018 trial – has been amended to remove the lower dose arm, which will reduce the number of patients required to complete the placebo-controlled trial from 900 patients to 610 patients.
Changes have also made to the 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 a placebo, Synairgen said.
The respiratory drug discovery and development company has also agreed to the addition to the trial of assessments for Long COVID-19 symptoms on day 60 and day 90.
Initiation of the first trial sites has commenced in the UK, with dosing expected to commence imminently.
Synairgen's investigational new drug application to the US Food and Drug Administration (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.
Meanwhile, the SG016 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 seeing recruitment and dosing levels pick up now after a slow start in the summer.
"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,” said Richard Marsden, the chief executive officer of Synairgen in a statement.
“SNG0011 is one of the few potential treatments to have shown efficacy against severe viral lung infections such as COVID-19, and multiple approaches will be needed to minimise the impact of this deadly virus,” he noted.
"There remains a great need to develop breakthrough treatments for patients who become ill with COVID-19, despite the recent successes from the vaccine developers. This is especially important if vaccine uptake is poor for any reason, or if any mutations in the SARS-CoV-2 virus render the vaccines less effective,” Marsden concluded.