Member Info for Brysoa

Apologies if posted before:

https://lemminginvestors.blogspot.com/

“If SNG001 gains FDA approval I seriously doubt Synairgen will survive as an independent entity, it will almost certainly be gobbled up by a larger pharmaceutical company. This is not just my opinion; it is the opinion of city sources. If correct, then Synairgen will command multi-bag status from and likely well ahead of Numis target valuation of £9.90p.”

Re the transition from ACTIV-2 phase-II to phase-III, I think that the key phrase in the RNS is “seamlessly expand”. This implies that there is a process of monitoring progress and that a go/no-go point is reached at about 200 subjects recruited (half of whom are generic controls). If the decision is taken to proceed at that point, the trial becomes P-III OVERNIGHT, as it were, still based on the original protocol, end-points, etc with some 100 subjects already under the belt. So, the timing of the transition is not critical. The fact of progression to P-III is.

.... and here is some information including the sites participating in ACTIV-2:

https://www.riseabovecovid.org/en/

Here is the link that confirms that, as of 10 February, only the SNG001 arm of the trial was under way, the other 3 candidates to follow. Of course one or all could be under way now - or not. It does confirm, though that we were ready to go.

Statement—Four Potential COVID-19 Therapeutics Enter Phase 2/3 Testing in NIH ACTIV-2 Trial The added sub-studies will test four interventions for safety and efficacy: SNG001, an inhalable beta interferon delivered by nebulizer, (Synairgen); AZD7442, a long-acting monoclonal antibody combination that will be studied as both an infusion and an intramuscular injection (AstraZeneca); and Camostat mesilate, an orally administered serine protease inhibitor that may block SARS-CoV-2, the virus that causes COVID-19, from entering cells (Sagent Pharmaceuticals). The first volunteer enrolled in the SNG001 sub-study on February 10. The other agents under study are expected to begin enrolling participants soon.

https://www.niaid.nih.gov/news-events/statement-four-potential-covid-19-therapeutics-enter-phase-23-testing-nih-activ-2-trial

.... forgot to mention the fact that there are 104 ACTIV-2 sites and, only 210 enrolments are required for the initial P2 phase; an average of just about 2 enrolments per centre. With the other 3 prospects apparently a tad behind SNG001 could we see enrolment within a week? Why not?

It is we shareholders that are sponsoring P3 worldwide through the November raise. US are certainly putting huge logistical support behind the at-home NIH Activ2 study, at a level and pace that would be hard to match for any small company operating alone. That kind of commitment and, hopefully, delivery at pace doesn’t come cheap. So thank you Dr Fauci, et al.

Statement—Four Potential COVID-19 Therapeutics Enter Phase 2/3 Testing in NIH ACTIV-2 Trial The added sub-studies will test four interventions for safety and efficacy: SNG001, an inhalable beta interferon delivered by nebulizer, (Synairgen); AZD7442, a long-acting monoclonal antibody combination that will be studied as both an infusion and an intramuscular injection (AstraZeneca); and Camostat mesilate, an orally administered serine protease inhibitor that may block SARS-CoV-2, the virus that causes COVID-19, from entering cells (Sagent Pharmaceuticals). The first volunteer enrolled in the SNG001 sub-study on February 10. The other agents under study are expected to begin enrolling participants soon.
https://www.niaid.nih.gov/news-events/statement-four-potential-covid-19-therapeutics-enter-phase-23-testing-nih-activ-2-trial

It’s official” - such sweet words. Even though we have known that this was in the bag for what seems like ages and didn’t doubt the veracity of the January RNS, it is great to see it in black and ****e on the ACTIV-2 website and to know that recruitment is actively under way!

It’s quite nice to see steady progress on the sp front in the absence of real news.and without any overt mm shenanigans. Confidence building for me, if I needed it!

Hold4results - thank you. 5 is better than 3. Just 15 more to go. I remain frustrated by the adverse effect of Recovery on the ground, their key goal seeming to be hoovering huge numbers of cases into their net.

The only key message I get from this is that only 3 sites are recruiting in England as of 1 February: Hull, Birmingham and Southampton. Is this because the super-trawler called Recovery is squeezing us out? And no mention of any starts elsewhere. Please correct me if I am missing something.

Kenneth
It’s a pity there seem to be no participating hospitals in Scotland for the P3 trial. Best bet if either needs admission may be Ninewells, Dundee from the point of view of MAP access. Prof Chalmers is the Covid guru there. Meantime, in addition to breathing exercises, they should definitely be taking Vitamin D and Zinc supplements. Dr Fauci allegedly takes 6000 IU of the former as prophylaxis. In addition, perhaps more contentiously, you should check out Nigella seeds and honey as natural antivirals. One RCT last year suggested some beneficial effect. No personal experience but, in the absence of access to interferon. Maybe worth a try. Worth doing research on in any case. Hope things go well.

It’s an interesting choice of paper for a senior medical academic to write to. Not chosen by chance, for sure, but a thesis could be written on the factors influencing the choice.

“Does anyone know or believe if synairgen will rns the first patients dosed abroad, or can we safely assume that the full international phase 3 trial has started? “

This is just my personal view but I am not expecting to see 20 or so RNSs announcing first dosing in the participant countries. It is one study, unlike the large vaccine studies mounted and reported individually in different territories (eg Novavax).

Really no point looking at the real-time reporting of trades. The big-ticket transactions are happening behind the curtain, to be revealed a day or two after the event.

Could it be the absence of any statement from NIH or information on the ACTIV website. The only “official” statement that I am aware of it our RNS, the accuracy of which I do not doubt. But it can’t have the same effect as confirmation from the trial sponsor will do when they get around to announcing it.

... trading at $2.85

This would be an important consideration in a P3 home based study - eg ACTIV-2 -going forward. Hopefully not a big factor in the home arm of the SG016 study as the majority of cases would have been recruited before there was too much new variant around. It seems not to be much of a factor in hospital treated cases as the hospital case fatality is, so far, reported as being comparable in new and old variant disease. Nevertheless something the statisticians will be looking out for.

Lock-in

I would be very disappointed if they hadn’t. In the Uk at least. But if you learn that one centre - doesn’t have to be Hull - is recruiting at the rate of n cases per week it gives you the basis to extrapolate to what might be happening overall and what we might be looking at in timescales - weeks or months.

Information on a lady who happened to be first patient recruited is not really useful. I wouldn’t be interested in any attempt to invade her privacy in any case. Ok, I know that she agreed to be on tv etc but she is still entitled to privacy now. But, if people have contacts in the Hull hospital, it would be useful to know the rate at which people are being recruited to the study. One a day or even every other day would be a very promising start. None since Ms Constantin, not so good.