Member Info for Brysoa

We are 78 days post recruitment completion on SG16. 12 to go until last 90 day assessment. I cannot see any announcement of interim P2 results now until they incorporate data relating to the full 90 day follow up. Anything relating to the 28-day follow up only would have been available long since. Assuming I am correct, the likely date of an announcement re SG16 is around 10 May, imo. Plenty of scope for information on other projects in the meantime. Patience is a virtue!

Kenneth ... sorry I did not make that clear. They are tweaking an injectable 1b commercial product and administering it by nebuliser. Home cooking. Is it that easy? If so what have Synairgen been up to for 10+ years? I don’t think do.

Yes, Dr Mary is a bit of a joker in the pack. He is clearly impressed with the performance of SNG001 in the p2 trial (hence use of slide showing the 001 results) and, in the absence of commercial grade inhalation IFN Beta 1, has decided with colleagues to try cooking up batches using injectable IFN beta 1b; think moonshine compared to commercial grade Bourbon whiskey. Except that there is nothing illegal in what he is doing as long as the product is not marketed. Hospitals have traditionally produced “special” products, often where no commercial pharma company considers it a viable option to supply. Dermatological ointments and eye drops are examples. So, a consortium of French hospitals could cook and use a home-brew product for use in their own systems. I think that this is their plan. Only if there was an attempt to commercialise the product would there be a need for it to go through P3 studies. Expensive and logistically only possible with a commercial sponsor. This could also run into ethical problems if there was an existing product (eg SNG001) licensed for use. In addition, I think it could only secure patent protection in its own right if it could be shown to be superior in some way to a formulation already patented. Whether the French government/EU would be prepared to play fast and loose with these legal, patent and ethical challenges and support the “Mary” initiative in the circumstances of the pandemic remains to be seen.

I am no expert but find the stability of the sp over the last 2-3 weeks interesting. No apparent big buys or sells by IIs, no apparent tree shakes. It’s as if everyone with skin in the game is hunkered down just waiting for the inevitable news, hopefully good, to hit and significant new potential buyers are similarly waiting for a signal of which way things will go. Eerie, almost!

Yes, Israel has a huge track record record in miracle cures ... going back 2000 years!

Lurker, “ A bit of the usual FOMO Friday will kick in I'm sure, but what's more important is that SNG is keeping a good price range on zero news and is another week closer to the #endgame. It's all good.”

I agree. I just feel something should drop on Monday, though, unless the home trial analysis is in the slow lane for tactical reasons.

... to see what, if anything, happens to the SP over the next hour.

COVERAGE TRIAL LINK:

https://clinicaltrials.gov/ct2/show/NCT04356495

COVERAGE trial link:

https://clinicaltrials.gov/ct2/show/NCT04356495

COVERAGE is trialling nebulised IFN beta 1b so not SNG001. The question is whether this somewhat shoe-string French initiative has enough steam to negatively impact on the progress of Synairgen. The study numbers are comparable to the SNG P2 study and one would expect that, in the normal course of events , would have to be followed by a formal P3 before the formulation was licensed. However, there is, as far as I am aware, no commercial pharma sponsor for the “product” to fund such an initiative. It is cooked-up in hospital pharmacies using injectable INF.

If the current trial is successful, who knows whether the French government could promote its use as an unlicensed preparation in the emergency situation of the pandemic. How would it stack up against SNG001 in safety and efficacy? Would it infringe Synairgen’s patent protections? Would current animosity between the UK and EU/France encourage the French to go ahead anyway? Interesting questions.

SYN00GOLD, I agree 100%.

This confirms that the only non-UK centre signed up is in Amarillo, Texas, and that it is not yet recruiting. Am I alone in thinking that this was not the pace of multi-national progress I was anticipating? Furthermore, it is interesting to note that there is a virtually total absence of participation in Sprinter in London and the Home Counties. I wonder why? It increasingly looks like most of our eggs are in the home-treatment basket, a point made in Sir Stephen’s most recent panel discussion last week, for the immediate term, at least.

Doc, Ferrari’s post appears to relate to a Serbian publication dated 2 February. If this is so, then it is very good news. Hard information that there were 40 recruits in the UK arm of P3 a fortnight after the start-up date with the prospect of 3 Serbian sites opening up within days. No?

Here is a link to a page with an abstract of the journal article in English. You can also access the full article on this page via the “PDF” button.

https://jvi.asm.org/content/early/2021/01/28/JVI.02415-20.long

Remember, Synairgen submitted a patent application last August for the use of SNG001 with corticosteroids in COPD and Covid-19. This Nature paper sheds further light on the interplay between the two molecules. It was a retrospective study with all of the contraints that that implies but good supportive information in any case.

179.90 before 9am. Nice to see!

My strong expectation is preliminary results statement via RNS next Monday.

Delayed volte-face!

I for one do not want vaccine failure. I know that the majority just want to put Covid behind them and get back to some kind of normality. Those who will be living with the reality of Covid for several years to come, however, will be the respiratory physicians, ITU specialists and other clinicians who will, IMO, be dealing with significant numbers of cases, particularly in the winter months over several years. We may not be talking about huge numbers by the standards of the current pandemic but we are talking about a significant and ongoing level of need, by no means fully met by current therapeutics. And that is before stockpiling in preparedness for a future pandemic situation caused by a possible variant virus breakout. The key question remains whether SNG001 demonstrates an outstanding efficacy at one or more stages in the disease. We will have answers to this in weeks. I remain optimistic, based on the science.

This meta-analysis relates to IFN beta 1a used subcutaneously in 5 randomised controlled studies. The fact that it confirms a benefit at a statistically significant level is good news, supporting the fundamental contention that IFN beta has a beneficial effect in Covid disease. What we know is that, when given by inhalation the beneficial effect is enhanced and the potential for side effects is diminished. So, I take great comfort from this paper which represents a further validation of the SNG001 thesis.