Member Info for spinnaker

I'd like one too please Speedie.

Best to all

Spinnaker

Thanks Matterhorn and Prion.

A very interesting read.

Spin

Thanks for that Prion

Yes I had read about the short form ACE and how that gave a scientific basis for the SNG001 treatment not promoting cytokine storm during P2 hospital trials. It just seems odd that this wasn't referenced in the paper just published. Also that there was no differentiation between INFa and INFb let alone b1a /b1b. I must admit I haven't read it thoroughly and it is no doubt above my head.

To be honest I don't really know the difference between INFb and INFa except that they are both type 1 interferons. It does look as though there are loads of different interferons all of which have a role to play in our immune system and I understand that SNG have hit on B1a to be the most important or most likely to be efficacious as a treatment. This seems to be supported by most of the documents I have read. I can see though that the current fashion is to give multiple products at the same time (****tails) and of course the logistics of trialing this approach with interferons will take years. I am satisfied that as far as the research I have done Synairgen's approach should be good, appropriate and protective against hospitalisation, severe disease/death and also long Covid. I do have trust that Prof Holgate and others know what they are doing from a scientific point of view. A plus would be commercial success and use against flu and other respiratory viruses in the future for COPD, asthma and people with other co-morbidities.

I am still very excited about the prospects for this product and the share value but a bit concerned that the number of competing treatments for trials may delay trial completions and authorisation.

All the best

Spin

Sorry for re-posting. Unintentional.
I think we are all pretty frustrated with the government's handling of this awful situation on so many levels.

I used to think that the people in government were somehow more intelligent or at least knowledgeable than I was but over the years have also grown more cynical as you obviously have.
Sleep well.

Spin

Hold 4

If you are criticising Lord Winston I think you have the wrong target. To be honest I don't really understand your diatribe. I do realise that it is late Friday night so that could be related.

Best

Spinnaker

Matml

Thanks for that link which I have sent to Synairgen. There appears little or any mention of INFBeta but the thrust seems to be that type 1 INFs may promote inflammation later in the disease and suggests that Type3 INFs may be a more effective route and less likely to promote severe inflammation.

I am not a scientist so would welcome the experts input here. I understood that the initial worries that late treatment with SNG001 could initiate over-production of Cytokines had been pretty much disproved by our P2 trials so a bit concerned that this paper seems to re-state that former concern.

Many thanks

Spinnaker

Thanks for that Ducati 2

I am pasting below a further part of Lord Winston's speech which points out his concern that monoclonal antibodies are not likely to be adequate as an early treatment. He is definitely a supporter of Synairgen. His statement linked by Ducati followed my email to him pointing out his error in confusing Lord Bethel. Very politely, both Lords sent me copies of their emails to each other prior to the 8th Feb Grand Committee debate linked. I do not however any knowledge of a substantive response by Lord Bethell concerning the government's view on Synairgen's product and the facilitation of treatments generally.

Best Spinnaker

'The science community has repeatedly warned that we shall almost certainly need to live with Covid for a long time to come. This is likely for Covid-19 but is equally likely to be true of other deadly viruses in due course. So, in addition to global issues, we need everything we can muster: vaccines, better diagnostics, culture facilities, better public health—especially globally—and drugs which kill the virus. We also clearly need isolation, and that will reoccur from time to time. It is important that we do not breathe a huge sigh of collective relief at the blessing of new and better vaccines. There are still many important questions that we will need to consider. Randomised controlled trials must continue. One NIH trial, for example, done in the rhesus monkey, showed that they got protection with different vaccines, but these did not necessarily reduce the replication of the virus in nasal tissues, while some others did. Those are the sorts of reasons why we still do not know how problematic contact between people will be.'

That's very encouraging Spred. Thanks for posting. It definitely seems to refer directly to Synairgen although again there may have been a mix up with one of the French inhaled interferon versions.

The reference to 1010 patients treated in trials is confusing so that doesn't fill me with confidence with some of the other detail.

Spinnaker

Yes I agree gkb. I hadn't realised that my copy and pasted excerpt transposed an = sign for >55

Spin

JoeyD, Thanks for that which I had already read. I agree surprising that IM arm was not run in parallel but perhaps the product was not ready in time or adequate P1 tests not completed.

One thing, I stated in an earlier post that the P3 trial for GSK/VIR did not include old people but having tried to find a reference for that I can't so it may be incorrect.
Certainly the target group was for people who were likely to have a high liklihood of disease progression so should have included the elderly and over 55s are specified below as included.

'Inclusion Criteria:

Participant must be aged 18 years or older AND at high risk of progression of COVID-19 or = 55 years old
Participants must have a positive SARS-CoV-2 test result and oxygen saturation =94% on room air and have COVID-19 symptoms and be less than or equal to 5 days from onset of symptoms

Exclusion Criteria:

Currently hospitalized or judged by the investigator as likely to require hospitalization in the next 24 hours
Symptoms consistent with severe COVID-19
Participants who, in the judgement of the investigator are likely to die in the next 7 days
Severely immunocompromised participants'

Fairly similar Inclusions and exclusions to SNG001 home trial but not, I think, identical. Above extract from NIH https://www.clinicaltrials.gov/ct2/show/NCT04545060

Definitely SNG product has some USPs compared to anything else I have seen so if it is proven to work and is priced reasonably I am sure we will get sales. The only thing that would be better for general roll-out internationally would be cheap pills and they don't exist at the moment.

Spinnaker

Simmo, You are right about worst case scenario. I am hopeful that the international trial will be completed well before then but since it doesn't seem to have actually started anywhere but UK, the timing is pretty much unknown . If it is partially completed say in USA and UK and one or two other countries in the next two or three months then it is possible that we would be able to prove overwhelming efficacy as VIR GSK but it seems the fact we are going it alone as a small company may mitigate against this, at least in some posters' views.

The P2 trial has not yet filled in USA but it is quite possible that EUA could be applied for whilst the P3 is running if P2 results at home in both UK and USA Activ 2 are very good. I think this is our best hope for an early (say May) EUA application.

Spinnaker

Does anyone know if Accustem will be listed on AIM or main LSE market? The fact that TILS shifted from AIM to main market on 21 Jan 2021 is presumably irrelevant. Also the requirements for main market listing may not be achieved by Accustem. Therefore I guess they will be on AIM.

If this is the case, am I correct in thinking that the initial price will be set in the opening auction?

Thanks

Spinnaker

You are quite right Ghia. Let's hope the UK gov. and its advisors recognise this and they don't rush out to order too many doses of the VIR-7831 just yet before Synairgen have completed their trials.
Spin

Hopefully Activ 2 will be quicker than the VIR ICE P3 trials that were announced in October last year.
http://pharmabiz.com/NewsDetails.aspx?aid=131648&sid=2

It does look as though we are 5 or 6 months behind at present.

vol Yes you may be right. There are two further differentiations.

Vir drug not tested on old people
Vir drug can do more harm than good if given too late in the day.

Well, an extra £5 on our share price would be nice but I think that would be called ramping!

Spinnaker

Now $62 - that's about $1.5 B increase in Capital Value due to successful P3 for a pre hospitalisation I/V treatment and confirmation that request for EUA will be made.

We have possible advantages over this treatment so bring on the Activ 2 results.
Namely:-
*Remote treatment possible
*Price
*Probable wider long term efficacy due to virus agnostic potential

Drawbacks may be shorter period of effectiveness in vivo but I'm not sure about this one.

Spinnaker

Amazing!
VIR Bio shares have just risen by $10 from $47 to $58 on NASDAQ That's an increase in Market Cap of c$1.2B on my rough calcs.

Just shows the potential value of what we have.

Spinnaker

A great thread. I agree with Doc and others that it is dangerous to assume there has been any significant progression either regarding the trials or manufacturing that has not leaked out. There are a number of holders on this BB that are spending a fair bit of time searching for just these nuggets on the web and on the ground at least in UK.

It is much too early for any progression from P2 to P3 in the Activ 2 trial. That would be market sensitive info and we would be informed by RNS.

My expectations of any swift progress on P3 is low and reducing but there may be a good kick for the international trial if we have a positive read-out of UK at home P2. If there is international media interest at this point it could give a real boost to trial recruitment levels for the international P3.

The UK winter wave has unfortunately been missed without the contribution that SNG could have made to reducing stress on the NHS and the cataclysmic death toll. I expect that although positive cases will rise significantly following release from lockdown over the next three months the hospitalisation levels may well stabilise at or even below current levels until next September or October as 2020. At this point the levels of illness will depend significantly on the effectiveness of the vaccine after 6 months and whether any new variants are expanding in the country following the summer holidays. Also the take up of vaccine in the 16 to 40 year age groups will be pertinent.

However, given the very cautionary advice coming from the government's advisors there will be a concerted intent by the government to be as prepared as possible for resurgence of infection during next winter. Undoubtedly this will include support for PCR testing and identification of variants, vaccine manufacturers and also stockpiling of variant agnostic treatments that have been approved by the summer. I am betting on SNG001 to be on this list. I also expect that the UK is likely to approve SNG before any other government except perhaps USA. BJ will want to ensure that he gets something else right before next winter apart from the vaccine. Also the current cold relations between UK and EU, if still continuing at the relevant time would mitigate against the EU authorising any British treatment too quickly. If the USA and UK give EUA the EU may follow but may not do so until full authorisation.

It's an interesting time and I am waiting expectantly having about 30% of my capital invested here.

Best to all

Spinnaker

I have posted below a list of anti-virals currently in trial. This is from a link from the Merck article. https://www.evaluate.com/vantage/articles/news/trial-results/molnupiravirs-big-day-draws-near

Best to all

Spinnaker

I think SNG still looks very solid subject to positive trials and not too much delay on the international P3. I would expect that we should have information from the P2 home trial before Activ 2 but this may not be adequate to change the status quo significantly. Activ 2 and submission for EUA /roll-on to P3 will be the more significant early SP catalyst IMO

Antivirals in development for Covid-19
Project Company Setting Note
Veklury (IV) Gilead FDA-approved in Covid-19 patients requiring hospitalisation Repurposed Ebola research project
Molnupiravir (oral) Merck & Co/Ridgeback Ph2/3 trials in hospitalised (NCT04575584) and non-hospitalised (NCT04575597) pts ongoing Repurposed flu antiviral
AT-527 (oral) Roche/Atea Ph2 trial in hospitalised patients (NCT04396106) ongoing; non-hospitalised trial due to start (NCT04709835) Repurposed hep C antiviral
PF-07304814 (IV) Pfizer Ph1b ongoing in hospitalised patients (NCT04535167, excludes severely ill or with certain pre-existing conditions) Repurposed SARS research project
MP0420 (ensovibep; IV) Novartis/Molecular Partners Ph1 trial in UK ongoing in healthy volunteers Designed for SARS-Cov-2
MP0423 Novartis/Molecular Partners Preclinical Designed for SARS-Cov-2; could be better against variants than MP0420 due to different targeting mechanisms
Source: EvaluatePharma & clinicaltrials.gov.

Apologies for double post

Spinn

Thanks for that post and link Johnny.

I see this was a tiny trial of critically ill patients based on licence on compassionate use grounds. The tablets performed better than hydroxchloroquine. I saw reference to another larger trial and will try and check that out.

Spinnaker