The P2 toolkit11 Jan 2024 17:05
For a long while I've been thinking that the company was preparing a new diagniostic test or tests - something they've developed and used in UNIVERSAL and were honing in readiness for the P2s. A super-test if you like or even a piece of hardware. But I now think this is wide of the mark.
What we'll get - instead - is a much more targeted set of inclusion criteria - based on Sprinter's deep dive, and perhaps augmented by anything new that UNIVERSAL reveals. Key features being Age / Oxygen saturation & Co-morbidities. We're all hoping that Casanovalabs is involved, ( their participation has not been confirmed by anything other than off the record barroom chat - but the stars do seem to have aligned with the most recent research paper from them ) Casanovalabs could provide their IfN auto-ab test, which might even have been used on UNIVERSAL and should certainly help to find a good cohort of the P2 patients, but it's not the most important aspect of what is to come.
And this is positive. I had concerns whether the company could create a revolutionary test without huge external assistance - but if they're "just" refining the inclusion criteria - and deciding how to balance the different determinants in setting the new protocols - then that's a much faster and easier road.
We should remember that in the Interim report in June 23, Synairgen highlighted viral pneumonia and mentioned ventilated patients, viral shedders and immunocompromised patients as the areas they were interested in.
Really really sick patients - and a world away from the loosely identified mass-targeting of Sprinter( positive for C19 and maybe lo-flow oxygen - but not always). Casanovalabs assays should help id the 2 and 3rd of these - but SNG001 has never been trialed with ventilators and it remains to be seen if any of the 300 UNIVERSAL patients will have reached this stage and have anything useful to offer. Ventilated patients on SNG001 would be something to see..
UNIVERSAL is critical in joining the dots between a multitude of respiratory viruses - and demonstrating that Synairgen's Covid and COPD data and SNG's method of action can read across to all viruses - but the Covid data from Sprinter, and the viral clearance data from the COPD study are overwhelmingly going to be the most important factors in designing the new trials.
" Conducting non-interventional preparatory work to expand hospitalised patient populations for potential treatment with SNG001, which are likely to include: ventilated patients with confirmed viral pneumonia; and patients who are unable to clear virus and become persistent viral “shedders”, a majority of whom are immunocompromised. Subject to this preparatory work and regulatory approval timelines, trials are anticipated to start in H1 2024.
Insights from non-interventional studies and the substantial body of evidence gathered to date from previous clinical trials will inform a robust clinical programme for the development of SNG