Member Info for Brysoa

Bizarre! All of today’s trading took place in the dark in respect of those immense Thursday trades and how they reflected market sentiment. If I had taken fright and sold shares today feeling that the sp was heading south because of a lack of buying sentiment, i would be a little miffed right now.

Firstly, those here highlighting the difference between systemic (subcutaneous or intravenous) interferon and SNG001 are right on the money. Inhaled delivery means less drug, direct action where its needed and less side effects.

I do think, however, that the publicity around the WHO trial may have a short term dampening effect on the sp. if I was in this for a fast buck, I might be a little worried by the reports. News from Synairgen in due course should sort that, though.

https://edition.cnn.com/2020/10/13/health/eli-lilly-pauses-trial-monoclonal-antibody-coronavirus/index.html

My understanding of the status of the ongoing SNG001 trial is:
The ongoing study started out in March as a trial comprising 2 components: a hospital arm and a home trial arm. The former made more rapid progress and closed in early July with the announcement of interim findings shortly in late July. The protocol was amended in August to the effect that, on completion of the second of the 2 initial arms of the study, now designated “pilot studies”, the trial would roll forward into a “pivotal” stage with a further 200-600 subjects enrolled (total with the original 210 now 400-800). The actual numbers required for the pivotal phase would be determined by the outcome of the 2 pilots. The pivotal phase would have the equivalent status of a Phase 3 study in regulatory terms.
We can only speculate as to where we are on the journey from the announcement of the revised trial protocol to final completion of the trial. My guess is that we are now into the pivotal phase but I have no idea how far into that we are and what numbers will have been determined based on the outcome of the initial home trial numbers. The listed date for the completion of the trial is 1 February 2021 but that is presumably based on a need for 800 subjects and limited availability of cases - so a worst case scenario. There must be substantial pressure to crack on in the circumstances of the current wave of illness. Let’s hope that we are close to the finishing line but recognise that we could have a while yet to wait. I also believe that peer review is a red herring - I am increasingly of the view that there is no intention to publish what is now regarded as one of two pilot studies and that we will not see a scientific publication until the trial, as now defined, has been completed. This is almost entirely irrelevant in regulatory and commercial terms.

Yes, toxic and really breathless. What a stupid man. He is taking the ultimate gamble. Whereas Walter Reed is a proper tertiary hospital, staffed by real specialists, the so-called “medical centre” in the White House looks to be not much more than a sick bay, albeit a rather plush one, staffed by an osteopath (Dr Conley).

God help him!

WedME, thank you for this synthesis. Very helpful even for those here who understand a bit of the science to have the strands brought together as you have done.

A question, prompted by another post, “competition dropping like flies”: Gilead’s trial of subcutaneous Rebif (INF Beta 1a) has been paused, at least for severely ill patients because of a higher incidence of adverse effects in the study arm. We know that nebulised SNG001 has a good safety profile. What is your take on this information in terms of implications for us?

The Daily Telegraph has an article today regarding “rationing” of Remdesivir. I posted the following comment there:

What has happened to the new Southampton interferon drug, SNG001, that was credited with reducing chances of serious illness ensuing in cases of COVID by 80% some 2 months ago? Since then - radio silence.
Meantime, mounting evidence from across the world seems to show conclusively that intrinsic interferon deficiency, either because of gender, age or other patient characteristics or as a result suppression by the COVID infection, is closely linked to the more severe, life threatening, form of the disease.
Why is there so little public and clinical focus on interferon treatment generally and the Southampton treatment in particular?

... for sure.

The early Cuban national experience with intramuscular beta interferon 2b described in this June pre-print is a reminder of the generic efficacy of interferons in COVID-19. I don’t know if it has yet been published formally but it informally validates the case for the use of interferon, however administered, in the disease. The SNG thesis is that beta 1a is more effective and delivery by inhalation is more directly targeted and less prone to systemic side effects than injected interferon.
https://www.medrxiv.org/content/10.1101/2020.05.29.20109199v1

Upup, I kind of agree with most of what you see in your inspirational post although I think the Trump angle is a bit of a stretch – hope I’m wrong! What beats me is why this amazing opportunity is attracting so little investment interest. Is it that there is very little understanding in the mainstream pi and maybe II communities of what we have here, so very little buying pressure? Is it that there are comparatively small numbers of liquid shares in the market - not enough to generate a meaningful market? Or are there dark mm forces at play holding the sp down at least in the short term? Maybe a bit of all 3.

We shouldn’t underestimate the significance of this development. To state the obvious, it would not be permitted unless there was acceptance of a compelling case for efficacy and safety. It’s like, “We know this works and is safe but have to wait for the regulatory machinery run its course. Meantime, you can offer this drug to any hospitalised patient in the UK and EU as long as their doctor wishes to use it with some paperwork around It’s use”. There will be a lot of lay and professional publicity about this over the next few days and I think that the take-up across Europe will be substantial. It is, in my opinion, a huge step forward. How this is reflected in the mad world of AIM in the short term is anybody’s guess!

Sleep well WedME. Been there, done that. Nothing like the feel of that duvet after a weekend on. At last, not only are all the pieces joining up but, as someone said here yesterday, the penny is beginning to drop in a big way. Hopefully, by the time you wake up we will be in clear blue territory..

Please forgive this pedantry but it is important: “Inhaler” and “nebuliser” are not synonyms. SNG001 is administered by a nebuliser, not by an inhaler. An inhaler, as typically used by people with asthma, is a pressurised apparatus that needs to be “fired” by the user in synchrony with inspiration (breathing in). A nebuliser produces a mist that is breathed in somewhat like the way one might use a vaping pipe if one was stupid enough to indulge in the habit. Nebulised medicines can be administered to sedated or ventilated patients with a bit of ingenuity in a way that a drug in an inhaler can’t. So, let’s keep to the term “nebuliser” when talking about SNG001.

It is a pleasure reading the insightful, mature and Informative evening and weekend posts here when the trolls and nutters who infest the daytime shift are missing in action!

Not an issue for SNG. Although Varona intend to test their bronchodilator / anti-inflammatory product in COVID, the product has no read-across mode of action In comparison with SNG001. Furthermore, the mode of administration is by pressurised inhaler and not by nebuliser. The former requires a degree of learning in how to use the device as well as being pretty well a nonstarter for a patient who is sedated. There are no negatives in this story for SNG and if there is a positive it is further confirmation that pharma is yet again demonstrating a belief that direct administration of medicines through the airways has distinct benefits over other modes of administration.

“ .... so tell me, Prime Minister, when you talk of ‘new medicines’, what, apart from dexamethasone, are you referring to?“ Bound to be asked, I would have thought.

Roche’s ACTEMRA damned with faint praise:

https://www.biopharmadive.com/news/roche-actemra-covid-19-positive-study-results/585490/

With all the high quality research posted here over the weekend, confirming the scientific rational for SG001 being a game-changer in the treatment of COVID-19, I feel it is inevitable that we will see a steady downward drift in the sp tomorrow morning!

Great find, Monticello. This article, published just 5 days ago in the uber-prestigious journal, Nature, draws a clear, evidence-based cause and effect relationship between a deficiency of Type I interferon (caused be the viral infection) and the onset of the severe second stage illness. In its last sentence the authors signal the potential benefit of interferons as a therapeutic strategy.

It all depends whether the intention is to seek publication of the in-hospital only results or the full study including the home treatment arm. I am increasingly of the view that it is the latter, otherwise we would have had peer review by now. If I am
right then it will be a while yet As I am not aware that the home based arm had concluded yet. By the way, the peer review process is relevant only in the context of journal publication of findings. As others have repeatedly said, pharma and regulators are not sitting waiting for peer review outcomes.