Member Info for Matml74

@NiceDay22 - Polygon up to 17% no doubt!

Seen this move by them too many times.

Bill again......

https://www.google.co.uk/amp/s/www.forbes.com/sites/williamhaseltine/2022/01/04/breaching-the-barrier-that-protects-children-from-serious-covid-19-related-disease/amp/

I like this bit......

”By my count, there are more than 20 different mechanisms SARS-CoV-2 deploys to suppress the induction of interferon and interferon-stimulated genes, as well as MHC-I. Each one of these mechanisms makes an attractive target for therapies that can protect children and adults from infection and disease. We must harness the knowledge and technology we have at our disposal to change the course of the pandemic for the better. Otherwise 2022 won’t look much different from 2021, with more and more infectious variants destabilizing our best efforts to recover from the damage of the past two years and forge a way forward.”

Becuase it’s a completely different trial looking at subcutaneous injected INF and it’s an interpretation of the data from that trial.

It could also relate to accessing government funding/contracts through Barda/US Covid antiviral funding programs.

https://www.niaid.nih.gov/research/antivirals

Robert,

I don't think many actually realise how significant a result the P2 data was. If you explore other FDA approved drugs for respiratory viral infections you will see that the degrees of improvement required to get approval are actually quite small.

For example take Zanamivir (Relenza) which is an inhaled treatment for influenza. The efficacy data was as follows:

• In the influenza-positive population (n = 1572), significantly more zanamivir-treated patients were rapid resolvers compared with those receiving placebo (807 [72%] vs 765 [64%].
• the median time to the alleviation of major symptoms was four days in both zanamivir groups and seven days in the placebo group (P< or =0.01).

When that drug came on the market it generated GSK $1billion in sales for what many would consider quite a small benefit (8%), although statistically significant, versus placebo treatment.

Tamiflu is another example which has been discussed at length on this board previously.

So if we take it back to SNG and covid, would authorities jump on a treatment that provided a 10 or 20% benefit over placebo? As there is no other covid drug in the hospital setting that can currently do that then it is still a good result. In the US at present that would mean an extra 10k to 20k beds not taken up by covid patient.

Obviously I would love to see P2 like numbers as it would mean a huge change in the direction of the pandemic but all I really want to see if a statistically significant result in favour of the drug vs placebo for the primary and key secondary endpoints of progression to severe disease/death. If that happens then the drug will get to market.

I struggle to SEE how this company can be valued less than £1b MCAP at the end of 2022 so I think 40p with a spike to 50p

Bill is one of the few journalists you will read who truely understands what this virus is doing and how it does it.

“These three studies lead to a conclusion that not only can SARS-CoV-2 suppress the innate immune system, it can also evolve to do so even more efficiently. This explains at least in part why Omicron is so efficient at transmitting from person to person. It underscores the importance of understanding the three traits that are most important in the pandemic: antigenic variation that allows reinfection of previously infected and vaccinated people; suppression of the innate immune system, which drives asymptomatic transmission; and speed of replication, which allows the virus to outpace the memory response.”

https://www.forbes.com/sites/williamhaseltine/2021/12/29/new-evidence-of-immune-suppression-by-sars-cov-2/?sh=5a92e50f4e76

Whilst the P3 hospital data is a company maker don’t underestimate the importance of Activ 2 in SNG001’s development. Data from that trial showing significant viral replication reduction will mean SNG001 will have a big role to play in outpatient setting as well.

Surely this has been done to death. Mattehorn’s post earlier today sums up the situation perfectly and is the scenario that is unplaying at present.

Topline 35 day endpoints (both primary & secondary) will be released between now and mid January.

Secondary 90 day endpoints will be released in March/April.

It has only been 13/14 days since the data was unblinded with Xmas impacting the timeline so mid January is a possibility but I think they should be able to get the topline out sooner than that.

Highlights

• COVID-19 experience calls global attempts to exploit knowledge on innate antiviral immunity for future pandemics.

• IFN-ß plays an early protective role in Sars-COV-2 infection and can mitigate disease progression.

• LAV and agents fostering innate immunity, including IFN-ß, may represent first-line strategy for controlling viral pandemics.

• Clinical trials with IFN-ß in COVID-19 patients should include personalized therapies based on novel biomarkers.

• Research on mechanisms of antiviral innate immunity should be encouraged for its potential impact on public health prevention strategies.

Apparently there are a few green boxes trying to deramp.......

“Emerging data suggest that IFN-I-mediated boosting of patients’ immunity, achieved directly through the exogenous administration of IFN-ß early post viral infection, or indirectly following inoculation of heterologous vaccines (e.g., Bacillus Calmette Guerin), might play a role against SARS-CoV-2. We review how recent insights on the viral and human determinants of critical COVID-19 pneumonia can foster clinical studies of IFN therapy. We also discuss how early therapeutic use of IFN-ß and prophylactic campaigns with live attenuated vaccines might prevent a first wave of new pandemic viruses.”

https://www.sciencedirect.com/science/article/pii/S1359610121000927?via%3Dihub

Ndn, Polar got involved well after P2 results but they did manage to buy a fair chunk around a £1 last Christmas. I think their average will be in the 140-170 range.

It is a rebalance as they have done most end of quarters this year (3 out of 4).

Andy, I understand the previous results completely. I have been here pre P2 readout. I did not state that I am expecting 20-25%, I said that this would still be a 'good' result when put in context of the other treatments available in relation to deaths.

The 79% efficacy you refer was for progression to severe disease in the P2 trial not to recovery. This will be a secondary endpoint in the P3 and I am hoping for a similar result for this endpoint. There are a much larger range of end-points in this trial that can provide a treatment effect signal which is good for shareholders as a non significant result in one endpoint, IMO likely to be the time to hospital discharge endpoint, won't mean failure.

Deaths weren't used as an endpoint in P2 due to the underpowered sample size otherwise it would have shown 100% effect in that. Any positive figure in reducing deaths in favour of the drug will be a big positive and will grab the main headline.

Doc, Those results would be absolutely exceptional and probably unrealistic based on the large variety of settings the trial has taken place in, the differing standards of care between each countries etc etc.

You need to look at what is currently available in hospital treatment and it is very limited. MAb's are basically now redundant until rejigged and basically trialled again. Dexamethasone which was hailed as a huge success provides a small benefit in late stage disease and little to no benefit in reduction of death in those receiving oxygen and non respiratory support cohorts.

"In the dexamethasone group, the incidence of death was lower than that in the usual care group among patients receiving invasive mechanical ventilation (29.3% vs. 41.4%; rate ratio, 0.64; 95% CI, 0.51 to 0.81) and among those receiving oxygen without invasive mechanical ventilation (23.3% vs. 26.2%; rate ratio, 0.82; 95% CI, 0.72 to 0.94) but not among those who were receiving no respiratory support at randomization (17.8% vs. 14.0%; rate ratio, 1.19; 95% CI, 0.92 to 1.55)."

https://www.nejm.org/doi/full/10.1056/nejmoa2021436

So IMO anything from about 20-25% reduction in progressing to mechanical ventilation/death would be a good result. However with the targeting of the 'breathless' patient group in this trial I am hoping to see a much greater benefit than that.

Polar are rebalancing. The examples you showed below for April and June were end of quarter rebalances!

UK ordered more Meck pills today despite the drug currently undergoing a UK trial!

LOL. Ain't that the truth. What the **** is wrong with the DHSC and UK GOV!

Thanks Matterhorn. Interesting they went 13 patients over the required amount. Must have been strong recruitment last few days of trial.

Think we will definitely get data readout early/mid January now with those changes and further 90 day data in late March/April.

Andybe, Good question. Polygon don’t operate like that. They buy for maximum return. Polar however, may have to rebalance according to their rules.

It’s an end of Qrt rebalance. Polar have done this 3 times this year. They added shares last month and this rebalance takes them just below where they were originally at.

Keep believing that champ! :-)