RE: Is anyone bothering to add to their positions?1 Mar 2022 16:34
Thank you for your enquiry and for your patience as we have responded to queries.
There was a rapid improvement in standard of care over the course of the pandemic. When the Phase 2 study was conducted, no patients in the Phase 2 study received systemic corticosteroids for COVID-19 at baseline whereas at the time when the Phase 3 SPRINTER trial was conducted, 87% of patients did. Additionally, unlike in the Phase 2 study, many patients in the Phase 3 study also received the direct acting antiviral remdesivir. This change in standard of care may have compromised the potential of SNG001 to show a clinical benefit in SPRINTER.
As announced on 21st February, we are reviewing the study's full dataset to better understand the detailed results and implications for development of SNG001 and will provide an update as soon as possible as in accordance with our stock market listing rules. While the overall study outcome is disappointing, we have observed an encouraging trend in prevention of progression to severe disease and death (36. 3% in the per protocol population), which we and our clinical advisors strongly believe merits further investigation in a large platform trial. We are exploring trials that might be suitable.
The study results will also be submitted for peer review with a goal of being accepted for presentation and/or publication as soon as possible.
In the meantime, we eagerly await the Phase 2 data from the US NIH ACTIV-2 trial in home- based COVID-19 patients, and that trial’s larger, follow-on Phase 3 study, as part of the development path for SNG001. Once available, we will review the Phase 2 data from the US NIH ACTIV-2 trial in home-based COVID-19 patients treated earlier in the course of the infection.
During the conduct of a clinical trial, the results remain confidential to the sponsors until all data has been collected, statistically analysed and quality controlled. This is to avoid any bias and premature disclosure. The statisticians passed us the quality-controlled data and the results were announced in line with financial reporting obligations.
As one would expect, in readiness for a potential favourable outcome of the SPRINTER trial, several operational plans were progressed (as announced to the LSE such as Ashfield and a general scale up of operations) to ensure we would be in a position to rapidly execute our regulatory and launch plans for this global health emergency.
As the world prepares to live with COVID-19, we recognize the importance of well-tolerated treatments and the need to ensure preparedness for future pandemics and thank you for your continued support
Brooke
Brooke S Clarke
Senior Vice President, Head of Communications
Synairgen