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The home delivery and remote patient support system has been set up with the MoH & NHS as a new endeavour to treat people in their homes - the expectation is it becomes a permanent program. If SNG can get the data they need out of P3/meta analysis, SNG001 could slot straight in to the program, based on the successful at home administration in the SNG home trial.

It's for Molnupiravir

https://www.panoramictrial.org/

Merck massaged their trial data and got the drug over the line w regulators and this is the result, govt both buying the drug and trialing it at the same time.

This has to be the goal for SNG now. An EUA or partial approval based on analysis and meta data, along with a phase 4 and/or confirmatory study in the real world.

This para from the RNS certainly looks to suggest the same:

"Synairgen expects to receive the Phase 2 data from ACTIV-2 in the first half of this year and will evaluate it alongside the full dataset from its SPRINTER trial to better understand the effects of SNG001 in patients at risk of developing severe illness due to respiratory viruses.

SNG001 has demonstrated in vitro antiviral activity against a broad range of respiratory viruses including SARS-CoV-2 and its variants including Delta and Omicron. The recent topline data from the Phase 3 SPRINTER trial showed an encouraging signal in reduction of progression to severe disease and death on top of standard of care (36% relative risk reduction in the per protocol population) which the Company is seeking to confirm in a large platform trial.*

The thing w a bad haircut is if you leave it, it grows out

Just to clarify, Dr Marys full tweet was:

****

"The COVERAGE trial is currently continuing with an inhaled interferon-ß1b arm."

Hope something can be merged with activ2.

*****
The 'hope something can be merged with ACTIV 2' is his comment, not mine

https://twitter.com/MARYau_MCU_PH/status/1503885540671860739?t=Su1NuKnQAkVSu1e1IRMBjQ&s=19

Dr Mary tweeted this morning (before the RNS dropped)

"The COVERAGE trial is currently continuing with an inhaled interferon-ß1b arm."

Hope something can be merged with activ2.

The quote is the last line of the study just published by COVERAGE - the link below

https://www.sciencedirect.com/science/article/pii/S1198743X22001082

"Conclusions
Our findings are consistent with the European Medicines Agency’s COVID-19 taskforce statement that there is currently insufficient evidence that inhaled corticosteroids are beneficial for people with COVID-19."

And at the very end of the paper (you'll need to dl the pdf and search 'interferon' to find it)

"consistent with the European Medicines Agency’s COVID-19 taskforce (COVID-ETF) statement
that there is currently insufficient evidence that inhaled corticosteroids are beneficial for
people with COVID-19.[21] The COVERAGE trial is currently continuing with an inhaled
interferon-ß1b arm.*

Nice find Titania, thanks for sharing.

This appeared around mid Jan. From the advice of some of the more informed posters on this board, I understand it's meant to qualify the questions asked to sprinter trial participants re breathlessness, etc by asking the same questions to non trial participating covid patients.

Thanks for the above posts.

This aspect:

"SNP rs9984273 is a relatively common polymorphism according to available data (REF: https://www.ncbi.nlm.nih.gov/snp/rs9984273#frequency_tab), carried by approximately 45% of people with African origin, 34% of Caucasians and 10% of Asians. This difference in the appearance of this SNP makes some populations much more vulnerable for steroid use."

Would seem to have implications for the geographical sub groups of Sprinter.

Thank you for sharing Titania

Found the thread with Richlist's chi square and some other clever contributions, regarding combined data - which is an interesting read some three weeks removed from the initial shock of it all.

(Bit of crap in there as well, but as it goes on this board)

I think this is so spot on. With hindsight, the parameters and primary endpoints of the trial were bound to fail. However, if SNG has gone through the same paces and can be seen against other in hospital antiviral treatments on a like for like basis, then it should put the company in a good place w the FDA etc.

Next question tho, did poly expect this and hence their buying since P3 results?

Nice find CMWW, thank you

Any media published by/of the company would draw attention, it would be linked to the missed endpoints and the P3 story would have more legs, more bot articles and more search results on Google. There is genuinely nothing good a media appearance would do without positive data to change the narrative.

Thank you for this insight Tommy D, hope you don't mind me re-posting.

TommyD_19

Today 10:37

Posts: 696

Price: 22.22

Merck MCAP 194bn employees 60k

Took 6 weeks from top line data to data readout analysis on Molnupiravir

Synairgen 16 days since Top line

I expect there is a PR School of thought that says get the bad out of the way, don't dress it up and then you can come in with full Positivity going forward.

Wigster

'Google "Synairgen" and the words "failed trial" aren't hard to find in the results unfortunately'

This is where I think strategic silence is a good strategy atm, let the dust completely settle, get your ducks all in a row and come out swinging when the time is right.

Published yesterday in Cell

https://www.cell.com/trends/immunology/fulltext/S1471-4906(22)00047-3

"The investigators also identified the presence of certain autoantibodies, including those targeting type I interferons (IFNs), that could predict PASC. Their observations suggest plausible mechanisms by which SARS-CoV-2 infection can cause persistent symptoms. For example, a higher degree of SARS-CoV-2 viremia likely reflects higher tissue viral burden and increased likelihood of end-organ damage. Higher viremia might also be associated with immunologic perturbations that could lead to organ dysfunction; some of these might persist beyond early convalescence. The relationships for other factors are less clear, for example, EBV viremia may more plausibly reflect the severity of initial illness rather than represent a causal mechanism of PASC, although the recent observation that EBV reactivation might lead to multiple sclerosis suggests this virus can contribute to autoimmune syndromes [2.]. Furthermore, the identification of a relationship with anti-IFN antibodies, previously shown to be important in acute COVID-19 [3.], suggests another mechanism that may tie together an impaired antiviral response, an enhanced inflammatory response, and generation of downstream autoimmune processes.
In a different analysis of several hundred individuals during acute infection and up to a year later [4.], Cervia and colleagues identified a distinct SARS-CoV-2 specific immunoglobulin signature during acute infection among those who went on to develop PASC. Specifically, they found that reduced IgM and IgG3 titers during acute infection were a risk factor for PASC, which the authors suggest might be related to reduced production of type I IFNs resulting in a failure of isotype switching. Using these laboratory measurements in combination with certain clinical factors (e.g., age, asthma history, number of acute COVID-19 symptoms), the team generated a prediction model to identify those who developed PASC [4.]."

Thank you for your excellent posts Tommy D

Would just look to add that we need to keep in mind that we are still well and truly in exceptional times, remove yourself from the UK and life is nowhere near 'back to normal' - the need for effective treatments is urgent.

The trial was run across 17 different medical jurisdictions, across the Alpha and Delta waves, with varying SOC and pressures on hospital beds etc.

Despite this, we still saw results in progression to severe disease and death consistent with the data from phase 2

We know from the results of P2 & P3 that the company can show statistical significance on this metric. It really can't be disputed at this point. We also know the treatment is safe, which given the history of interferon is an absolutely huge hurdle overcome.

Whether regulators would accept that for an EUA is of course an entirely different question and one I expect no one here could answer. However, from Tommy's posts above (and others on here over the last week's) there are certainly examples of drugs that didn't meet their P3 endpoints that still gained approval.

10-12 weeks would look to be consistent with the upward trend in cases/hospitalisation in the UK, considering the booster roll out was Nov/Dec