Member Info for spinnaker

Yes. Well done Mike.

Start of trial 27 April in all 11 sites. Target is 87 patients to be recruited for Spain. Spain currently has about two or three times the infection rate of the UK so I would hope they would manage that in two or three months. Say one trialist per week per hospital.

Take-up is subject to interest by the doctors at each hospital and also the number of competing trial products. Also of course hospitalisation rates which will currently be reducing in line with infection rate.

Best to all

Spinnaker

Geovanni Thanks for that link.

A bit concerning was the paragraph stating that post peak viral infection treatment with inhaled interferon carried more risk. Although that was a worry SNG had pre P2 trial that concern wasn't borne out by the SNG P2 20 July results and certainly the amendments to the home arm protocol and RMs last couple of interviews imply that SNG have become increasingly relaxed about a longer delay between infection onset and treatment. In fact, I doubt if very many of the triallists so far have been first dosed in less than 7 days after infection.

Interesting that this is the second paper on the BB today that indicates the earlier the interferon dosing the better the likely outcome. Accurate, fast POC testing and biomarkers for likelihood of progression to severe disease will be important to correctly target most at risk individuals and optimum treatment window for our treatment. I expect both these techniques will prove invaluable in the future. I regard the 'breathing difficulty' criterion to be a rough and ready measure that will not pick up patients very early but probably the best we can do at present before more nuanced and earlier identification of the patients most likely to benefit will be available. It isn't totally objective but the good thing is that it is an easy diagnosis to make and can be readily self-diagnosed.

I am hopeful that we are bumping along the bottom now in terms of share price and future news is likely to be positive for Synairgen.

Best to all

Spinnaker

I have emailed Clinigen to ask them to confirm that this old news from France is part of the international MAP that they are co-ordinating. I also asked if they could give any information on numbers treated under MAP in any/all countries. I have asked questions before and nothing was forthcoming and resulted in a circular journey to Synairgen and sent back to Clinigen.

It certainly looks to me that this is just is all part of the MAP. However I find it pretty annoying that no effort has been made to inform shareholders of the progress of MAP.

I am now beginning to think that due to the costs of initial funding of the supply of treatment which may be eventually refunded in some instances (perhaps coupled with limited availability) and the ongoing cost of data collection and provision post treatment, Synairgen have merely used MAP as a box tick and have not actively encouraged take-up. Certainly Clinigen have informed me that they are not able to carry out anything that may be considered marketing or promotion. There is though, a big difference between marketing and facilitating access to treatment for any doctor that may enquire on behalf of a patient. I am sure that if there had been any significant take-up we would have been told since it would be price sensitive information.

Best to all

Spinnaker

Thanks Titiana

I agree with Schrow and Andym. A fascinating read.

Truly unbelievable that the supposed P3 trial results have not been released prior to EUA.

https://www.republicworld.com/india-news/general-news/what-is-virafin-dcgi-approved-drug-claims-91-percent-covid-patients-return-negative-in-7-days.html

Big 90% plus headline recovery but no publication of P3 nor any mention of trial size.

Seems to be administered by injection. Doesn't say whether I/M S/C or I/V

Further info will be interesting to see but no doubt the company will be churning out the numbers of vials right now. For India's sake, let's hope this does actually work without severe side effects but I have no idea how the dose levels compare with the WHO Interferon Beta trial which was negative for efficacy. Also the journalist who reported (in Titiana's post) thought it was ridiculous that the drug had been approved prior to publication of P3. The P2 was totally inadequate not only due to the small sample size, (less than half the size of SNG P2) but also because it was not blinded to the treating physician. Even India wouldn't have approved it based only that P2 trial. Also the P2 results were only published in April 21, some 5 months after the Lancet publication of SNG's P2 results. It does seem pretty amazing that 250 people for the P3 trial were recruited, dosed and results analysed so quickly.

All very strange.

Best to all

Spinnaker

dafad
I can't seem to access the article. Does one need to subscribe?
Thanks
Spin

Just saw Bryosa's extract.

Please substitute 'lower risk of progression' for my 'not very ill' and vice versa.

Thanks Spin

Matterhorn

I also think I read something like that in the protocol. Ie it would be an algorithm or randomised but nevertheless if most of the patients are not very ill and they can't be given I/V or injections, the chances are that there won't be many people in the SNG trial who are displaying severe symptoms. I did think at the time when I read the protocol that they would have to either decide to either give a fair proportion of the severe patients the non-invasive treatments or equalise numbers on the trials. They obviously could not do both. In the former case the two non-invasive trials would fill up much more quickly than the others. This does not seem to be the case. Therefore I surmise that they are equalising numbers in each trial and this would automatically mean that a very high proportion of the cases treated with SNG001 would not be very ill.

Best Spin

Doc, it might be best to filter Oak as I now have. We don't want the board taken over by a personal spat.

Spin

Matterhorn and Matt

I don't think we are misinterpreting the doctors words but he may be misinterpreting the protocol as I implied below. The protocol did not have the intent to limit SNG to less serious patients but that may happen by means of misinterpretation of the protocol and/or the natural situation that seriously ill patients are sent to hospital for I/V treatment leaving only the not very ill for the Camostat pills and SNG.

Spin

Doc, re your 19.31 post.
What would be even better is if they put us into P3 in Activ-3 in parallel with upgrading to P3 in Activ-2.

That would definitely be positive for the SP.

Spinnaker

Great news from Kansas. Doc see 35 -38 mins. A very good question but Kansas was only able to give recruitment figures for that particular hospital. Slow take-up. 40 total for all 5? Activ-2 treatments and about half a dozen for SNG001. We don't know how many centres have SNG so it is difficult to extrapolate total take-up.

The protocol stated that I/V would be generally reserved for more serious patients and I suppose the corollary is that there will be more of the less serious cases for interferon. I am not sure this was the intention but the Kansas guy definitely said that the less serious cases were being used in the interferon trial. About six so far out of 40 in Kansas and he thought a few weeks to fill the 110 people for SNG and then to be assessed for suitability for P3 by external bodies inc FDA. Hopefully more hospitals will be recruited if and when we get into P3 (1000) patients.

It definitely seems that our treatment has been slower to fill than the Brii product. Also if only less serious patients are being treated with SNG it may well be that we will only get safety data and not much to help efficacy figures. This should not prevent progression to P3. I am sure Synairgen will ensure that the data from the home trial will be given to the Activ-2 trial administrators and there is certainly a possibility that the protocol for P3 will be changed in order to obtain statistically relevant figures.

Best to all investors

Spinnaker

Thin Shins

I agree entirely. Fingers crossed.

Hasn't the Brii product just been promoted to P3.

Spin

Too right GKB. I have also been posting similar for months.

Prion, on your point about RM's expectation of 30% hospitalisation. That was way out wasn't it? I expected less than 10% and posted such, months ago. Given the Activ-2 entry criteria are wider, at least for the current P2, the hospitalisation rate may well be lower than for our home trial. This may explain why RM ignored Activ-2 in the briefing interview.

Spinnaker

There are some very genuine and sober posters on here paticularly Ghia , Harchris , Matt and Doc most of the time. I am not surprised Doc is frustrated. So am I. There are other posters like Oakleaf who remind me of the politicians on Question Time who trot out the same party line garbage irrespective of the question asked or the truth and call people names. One doesn't know if they actually believe what they say but suspects very strongly that they don't and are just saying it through habit or Pavlovian response.

We are mostly frustrated that SNG has not contributed to help prevent deaths in the UK over the winter. I expected a tie up with a big pharma after July and government assistance and then EUA EUA. RM stated the rate of progress was dramatic and this most certainly was the case between March and July but since then it appears to be back to the normal speed of pharmaceutical development and trials as though there was no pandemic.

Very concerning that RM did not mention Activ-2 in the interview. Also no progress on MAP, not even confirmation that one person has received the treatment, no indication of any product yet available and no offer of donation of product to India. No news on P3 progress other than a delay of three to six months and no news on Long Covid data from the home trial. Before anyone comes back, yes I do realise that an interview with Katy is not the place to give new news.

I suppose given all this and the fact that with present information there is now limited hope of approval in time for use next autumn/winter during the expected fourth wave it should be no surprise that the SP is floundering. What a crying shame.

Spinnaker

Thanks Matml

Obviously there is a hell of a lot of research going on in China at the moment and has been since the start of the pandemic. This paper comes from scientists all based in Guangzhou in Guangdong province.

The conclusion was about the only bit I could understand and it is clear that these guys think treatments and prophylactics are urgently required. and Interferon B should fit the bill. As we all know however, no matter the scientific evidence that SNG treatment has an excellent and widely accepted academic and in vitro research basis for efficacy, that is of no value in the regime of required human clinical trials that we are signed up to. There is no difference between a treatment that nobody has a clue why it might work and one with a logical theoretical scientific basis. The proof of the pudding is in the eating. The weight of evidence we already have leads us to consider that the chances of trial success should be very high but there is still a chance that the numbers won't be adequate to be statistically significant on any of the individual Phase 2 trials and only an amalgamation and meta analysis of all trials including both Phase 3s may be required.

The only thing that will enable authorisation in the west is successful and statistically relevant trial results. Unfortunately, most of us, are probably well down on our investment at current SP and the try line we are attacking does not appear to be getting much closer after multiple phases still retaining possession. The only thing that we still cling onto is the belief that the science is sound and we will score before the end of the game. If the game is refereed fairly we should emerge victorious but there are many tackles and possible turnovers still to come no doubt and we must never underestimate the oppo.

Sorry about my rugby metaphors.

Best

Spinnaker

Hi Matterhorn

I have written to Clinigen last year, I think, and they said they can't give me any info re any treatments requested or supplied under MAP and referred me to Synairgen. Synairgen referred me back to Clinigen as I recall and gave no information. As far as I was concerned MAP could have been a very good way to get visibility and at least anecdotal evidence of efficacy if not up to the standard of a formal trial.

This MAP status could have been utilised to save lives, produce additional data and provide promotion as a by-product and still can but no information has been released. The only feedback was from Kenneth who posted on here months ago about his father in Dundee but I don't think he got anywhere with either Clinigen and the doctor in charge of his father was more interested in promoting a local trial drug. That's not much info!

Even if SNG can only manufacture 10,000 this month and donated them to Delhi or wherever under compassionate use protocol I am sure Indian doctors would be very grateful and provide us with some data in return. The BoD do seem very blinkered and we have not been informed of any progress.

Unbelievably, Consilium were not prepared to release or possibly didn't even know the list of P3 trial countries when I asked them even though it had been reported by Synairgen to NIH and was in the public domain and posted on here immediately after my enquiry.

I am not sure there is enough oversight, carrot or stick being applied to our advisors, Consilium and Clinigen.

Spinnaker

That is a very interesting suggestion soonbetime. However I think that, politically, in the west, at least, your proposal would not be seen as P.C.. So long as we have the possibility of chasing the vaccine magic bullet that will be seen as preferable to rampant infection and treating those exhibiting breathing difficulties and at severe risk of serious disease. There is a possibility that the establishment view would change in the future if the vaccine effort was seen to be failing but certainly not at present.

Having said that, the UK is unusual in having a very high proportion of people willing to take up the vaccine and therefore although the current target market for SNG001 in Britain is small, this is not the case in many other parts of the world including much of the US and parts of Europe. I still feel that if we can get authorisation before the winter we will be able to sell the product in quantity.

I am still spitting blood that we have had no information released on MAP penetration and Clinigen may not have supplied the drug to anyone yet. Very poor show.

I am not sure of the cost price of the product but in exchange for a legal release and agreement to provide data it could be a great humanitarian and PR move to donate say 100,000 (or even 10,000) treatments to one or more Indian states for compassionate purposes right now. I certainly hope that some of our investment has been put to stockpiling the product, otherwise if and when we receive approval there won't be any fast roll-out. Also Scinv may have a valid point that without proof of ability to deliver in quantity short-term the US authorities would not countenance EUA. We would therefore have to wait possibly up to Christmas and publication and Peer Review of P3 hospital trials before any authorisation is granted.

Very disappointing at present not helped by the fact that sentiment is diabolical, general market has shifted to value stocks and SP going through the floor.

Best to all

Spinnaker

Yes Prion I know. What amuses me is Germany is going off on a complete tangent to EU central.
Spin

Another good thread with a broad range of views.

I didn't see the live conference but an abridged version. I don't remember hearing anything about the 30 and 90 day results. Can someone please tell me why these results have not been released, I saw mention in this thread about signing further patient acceptance forms. Do we have an indication of timing for release of this information please?

Very disappointing SP move on Friday and I am not totally sure that there will be a recovery next week. I do agree that there is negative sentiment partly due to delayed timing of P3 trial news enhanced by the UK excellent reduction and now stabilisation of rate of new infections despite the gradual lifting of lockdown. Surprisingly it looks at the moment as though things are proceeding as per government expectations and plans for a change. However infection rates in Germany and France are ten times ours so there will be plenty of scope for new variants which may upset the current status quo, particularly if travel restrictions are eased. Also the progression of Brazil and Sth Africa strains together with Indian strain potentially.

There is still all to play for but the Covid target market is smaller than we imagined back in July and there will be other drugs in competition by the time we get P3 results and (hopefully) subsequent approval. Like most on here I am depressed that despite all the company's efforts thousands have died who could potentially have been saved over the winter months and it no longer looks certain that we will have approval and mass manufacture by September in time for next winter.

Good luck all

Spinnaker

I can't see this cheap drug getting out there anytime soon without government money from somewhere to run approved trials. If it was found to work it could be a very cheap prophylactic for places like Brazil and India who don't have fast or deep vaccine coverage.
https://trialsitenews.com/germany-conservative-party-from-bavaria-promotes-ivermectin-for-e50m-clinical-trial-fund-targeting-covid-19/

Best

Spinnaker