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mact4 - The subsequent changes to the protocol would be beneficial from a phase III perspective as only high risk patients are eligible. From a phase II perspective I don’t think the changes impacted us - difficult to say really. The initial phase II recruitment criteria had a wider scope (low & high risk). Most importantly for phase II we need to show safety and early reduction of viral load/improvement in symptoms.
Matterhorn, my poor brain can't take in all this data. I had to sleep on the conversation between Dudio and Ghia to process their discussion!
Is your opinion that the more up-to-date protocol more beneficial to SNG001?
mact4 - the inclusion criteria for ACTIV-2 phase II which were applicable to SNG001 were more relaxed than SG016HOME. It’s changed in subsequent versions of the protocol. Based on the latest version phase III is more aligned at least from an age perspective.
BigjohnnyWin - politicians don’t approve drugs!
That is a pretty bold statement I would say.
Kevin. It's the Synairgen board, so people are welcome to express their opinions on the treatments. Most of us posting come from different educations and try and offer something useful.
All the best
I guess employing clinical research people for the launch of sng001 tells us all we need to know
RM is confident anyway.
‘ Synairgen is a respiratory-focused pharmaceutical company preparing to launch SNG001 for the treatment of COVID in the US, UK & EU.’
Why not leave the research and data gathering to RM and his team of experts, rather than guessing the next steps.
It is an undisputed fact. We are getting closer to results each day - time flow is linear and one-directional! :-)
We must be getting very close to results given the number of people who seem desperate lately to point out that interferons and Synairgen treatments don’t work.
Dudio, you may be right that meta analysis of both sets of data will give a better and clearer reading for SNG001. It would certainly be a positive move.
There is one big difference between both trials (maybe the experts here can confirm. I must admit to getting somewhat easily confused with the different trials!).
Inclusion in for the SNG016 home trial, only required a positive Covid test and a risk factor.
Activ2 inclusion requires a lot more including breathlessness (criteria 3 in a long list of acceptable symptoms) ie giving SNG001 more of 'a fire to put out'
Ghia. My second post is just a summary of my first! ;-)
Dudio - I agree with your second post and I’ve mentioned previously the @home data solved a big problem for us.
If we had shown stellar results in everyone this would have pushed us into the mass market high volume but low ticket price.
As it turns out we are a more targeted drug which is really effective in those that need it. Hence a large ticket price is justifiable and this is likely the more lucrative market.
Sng should send all tory cabinet ministers a million free shares. We would have authorisation in no time. Brown envelopes for bungleboris and his chums are all that our leaders take as a drugs efficacy.
Dudio
I just hope they obtain more quality data from Activ 2 which includes the effect of sng 001 on viral loads and its efficacy on a range of variants . There are opportunities to use screening tests for interferon deficiency for those who will develop severe disease which makes it more cost effective and there are also other biomarkers other than breathlessness .Its taken longer than I hoped but its proven safe and quality data is king
Ghia. Good to see you posting again.
Regards
SNG001 isn't going to be given to everyone. It's too expensive for starters. It's role is likely to 'put out fires' as RM suggests.
It'll be those with breathlessness in the home setting or who have been admitted to hospital.
The Home trial didn't produce enough data for this cohort.
I suspect Activ 2 P2, as a home trial may not produce enough data either.
But combining relevant data from the Original P2, Home trial and Activ 2 P2 (a meta analysis), might give more evidence for SNG001's role before any P3 results come out.
Dudio - I think you have drawn the wrong conclusion from the @home data.
“ more confirmation that Synairgen isn't right as a broad combatant of Covid”
The data did not suggest this the data actually suggested that the majority of patients who caught covid including those in the presumed vulnerable age range and risk factors would experience very mild symptoms.
Ergo you might as well give them something to mask the symptoms and let them get on with it themselves.
What the data did suggest is that there may be a way predicting at an early stage who is likely to need intervention and that SNG001 is a very effective drug at treating these patients in the home setting, as well as being effective at a later stage in the hospital setting.
I’ve been pondering.
Synairgen's Home trial data was seen as disappointing. Albeit, Synairgen now hypothesise that their focus is: patients with breathlessness, partly on the back of this trial.
In the 'car crash' presentation on the day of Home trial results, Synairgen pooled together some of the data from the Home trial and added it to the original P2 data. Let's call this P2+
Now we're soon to get data from the Activ 2 P2 trial, which is another home trial and perhaps we'll again get disappointing results, because there won't be enough of our sweet-spot of patients with breathlessness and or hospitalised.
So, surely Synairgen will add any relevant 'breathlessness' or 'hospitalised' data from Activ 2 P2 to the 'P2+' data, using a meta analysis?
Maybe what we'll get from any Activ 2 P2 data / reporting is more confirmation that Synairgen isn't right as a broad combatant of Covid, but a bit more data to back up the hypothesis that their sweetspot is those with breathlessness / or have to go to hospital?
But then how would the market react to this? Positive, because there's more proof with more good data to back up their hypothesis? Or negative, because Activ 2 P2 isn't seen as the silver bullet?