RE: Disappointing, but what comes next?1 Oct 2021 19:43
Here’s my analysis of where we are.
1. COVID-19 is not going to go away. The nature of the virus and mutations means that vaccines and mabs, while effective will always be subject to playing catch-up. The present situation with near maximal vaccination of many populations with effective vaccines is about as good as it is ever going to be. Still we see breakthrough infections close to bringing hospitals and countries to their knees. Mabs as therapeutics only effective in those who are anybody negative ie the unvaccinated, previously unexposed or those without persistent antibody mediated immunity.
2. SNG appears on the evidence we have to be very effective. Being considered fir progression to P3 of activ2 is really sound evidence of efficacy. Activ2 has target recruitment if nearly 9000 patients. Ineffective treatments have been kicked out. The structure is such that license holders can decide not to go to P3. Remember p2 is placebo controlled, p3 is against regeneron. I don’t think we know the fine detail of this. I would think it needs to be a level playing field for SNG board to agree to go through ie not just antibody negative patients- that would bias towards mabs in outcome. I think the board are currently thinking carefully about this.
3. SPRINTER trial is 80% recruited. That is incredible. COVID is such a fast moving target that it can be difficult to setup and recruit to. The November final recruitment is only 1 month off target.
It is of coarse not a foregone conclusion but there is clearly going to be a big COVID therapeutic market ongoing. All the objective evidence we have is positive for SNG. This is just another blip on the way, based on about as much evidence as the last blip in April. I’m holding firm for all the reasons outlined above,