Member Info for Brysoa

I don’t know if this has been mentioned on here before but I have wondered since the headline results were announced whether the companies intention was to wait until the end of the home trial before completing the analysis for publication of a single integrated paper, In which case we shouldn’t expect to see peer review results for quite some time yet. Maybe someone knows for sure that this is wrong.

Nothing new about the Amiens trial. It’s been on the radar for a couple of months. But it’s an open label, single centre In-hospital, oxygen-supplementary-only study not yet recruiting. Who knows what the formulation of their IFN is in terms of pH, etc. Is it patented? Can it be patented? Lots of questions. Maybe SNG and/or their patent lawyers know the answers. Ditto the significant IIs of recent days/weeks. It is not impossible that this study will never get off the ground, let alone be completed - unless, of course, the French government/EU decide to weigh In with support.

The SP response to today’s news is bizarre and must be being managed behind the scenes for some purpose. I can’t see a chink in the SNG armour And expected a much more positive market response.

In fact, I would go so far as to say that those few missing words put a completely different complexion on the RNS. Much more positive that it reads without the numbers.

Thank you AscotMatt. And what a tit-bit to miss out! “Significant“ would be any value of <=0.05. Values of <=0.001 are very highly significant indeed and highly relevant to the COVID applicability.

Hopefully we will get an update of the RNS including the missing p value in:

“Over the treatment period, lung antiviral responses to viral infection were significantly enhanced in patients receiving SNG001 compared to those on placebo, as assessed by measuring increases in the gene expression of interferon beta-dependent antiviral biomarkers MX1 (p=“

Rather an important fact to be inadvertently omitted!

Hurrah! I just worked out how to do it! It’s done!

Re Feedmyeyes ...as a relative newbie here, can someone kindly explain how I go about filtering nutters like this out!

I reckon there is absolutely no intelligence to be had looking at the reported “recent trades” in real time. Most of the big trades that drive the market are reported late - sometimes days late.

I keep looking for evidence to support the argument that there is a weakness in the case for SNG001. Prof Wilkinson, the PI on the Phase II Covid study, who we should remember is formally independent of Synairgen, lays out In this video the headline results in a very straightforward way. His reputation is on the line and you can take it that he is not overstating the case. As time goes on I am more And more of the persuasion that the peer review process, if initiated as seems to be the case, must be complete. If so, the only reasonable interpretation for the absence of a further announcement/RNS is that there is a commercial, as distinct from scientific, reason for the delay on release of information; Ditto the COPD study. How can this be other than good news for shareholders, even if in the short term it is tantalising and a bit frustrating?

Hi modpod. Same background but public health specialty; same sentiments re sng001. The key is in the route of administration. Good results In other studies with injected interferon beta products validate the efficacy argument but with big caveats re side effects that a nebulised product seems to avoid.

Good analysis, jm4910. Where I differ slightly is in the determination of the numbers required for the pivotal add-on part of the study. I think that the revision makes it clear that the number needed will be determined by the outcomes of both arms of what are now described as pilot studies. If the home trial results mirror the hospital treatment results then you are right and the additional numbers should be at the lower end of the spectrum. In any case, that number will not be determined and the pivotal extension will not start until the home trial is complete and headline results available. So that is a rate-limiting factor. What is very good news, though, is that all of these elements are being rolled up into a single integrated study that should act as a Phase III equivalent and that a pathway is now clear towards regulatory approval. Whether anything materialises in the interim in the way of EUA Is anyone’s guess but the prospects of this could be enhanced by a good COPD trial outcome, demonstrating anti-viral efficacy.

In the EUA authorisation statement on convalescent plasma, the FDA say,
“The FDA determined that it is reasonable to believe that COVID-19 convalescent plasma may be effective in lessening the severity or shortening the length of COVID-19 illness in some hospitalized patients. The agency also determined that the known and potential benefits of the product, when used to treat COVID-19, outweigh the known and potential risks of the product and that that there are no adequate, approved, and available alternative treatments.“
It’s worth considering each part of this statement carefully. Taken together they represent a very guarded position on the efficacy and safety of plasma treatment. Damning with faint praise, I would say. The key is in the last part, to the effect that this Will have to do until something that actually works comes along.

If it’s Rebif it will represent at least a medium term plus for sng001 as will validate the argument for interferon beta 1a but with the attendant disadvantages of systemic delivery. For this reason, I would prefer to see Rebif as the great Trump hope than something else.

This document sums up my reasons for investment, particularly the section on pharmacokinetics and on side effects of systemic administration of Interferon beta. Also the statement that it seems unlikely that inhaled interferon beta is associated with systemic absorption. Hence no or little by way of side effects.

https://www.cebm.net/covid-19/drug-vignettes-interferons/

Well said, breath easy!

B2hs2L .... I think you were making this point about side effects of interferon beta: that it is pretty toxic stuff with a substantial propensity to do harm to people and make them feel unwell. All medicines are poisons but good medicines focus their effect on tissues and cells that you want to influence or damage (eg cancer cells) with minimum collateral damage to surrounding health tissue. So you need to try to get a drug to the point of maximal impact in maximal concentration there but minimal concentration elsewhere. Giving interferon by injection is s bit of a blunderbuss strategy. Giving it by nébulisation is very much more focused on maximal delivery to the respiratory epithelium and much lower concentrations and adverse effects elsewhere. The article you quote refers to injectable interferon and actually very much strengthens the case for sng001.

Sparkle1. Not following, I am afraid.
1. nebulised material can be administered via ventilator to sedated/unconscious subjects.
2 in any case, the subjects in the study cited by Medicalstudent88 were not unconscious.

Good research, Medicalstudent! A couple of observations: In the absence of any statement to the contrary, it looks like the interferon Beta 1b used in this study was administered intravenously or at least by injection. You will know this from the full text paper. I say this, knowing that there are some groups playing around with (or contemplating doing so) nebulised preparations of interferon species, one of which is in France and another in Canada, I think.

Assuming that this study is using INF beta by injection, although they are demonstrating an effect it will be at the expense of much higher doses than are required in a nebulised delivery. Also, the patient is exposed to greater likelihood of side effects due to the drug. It seems to me that sng001 faces 2 potential hazards, assuming Of course that the preliminary study results are borne out: firstly that the patent protection of a nebulised delivery formulation can be circumvented using a different IFN species or a different delivery formulation and secondly that parentéral delivery is just as good in cost benefit terms. Interested in your thoughts.

Yes, ChrisToffer, I had a look to refresh my memory. The trial is, as you say covering the hospital and home arms and the latter had yet to run fully. Anyone interested the code number is SG016. Nothing is impossible but I would reckon that the scientific report will not be written up until the second arm is complete and analysed. Again, that is quite a different matter from the statement made for market regulatory purposes last week and any ongoing engagement with regulators.