Member Info for Brysoa

“Stella gains”? How much lager can they get?

gave = have!

I remain mystified as to the game-plan of the French group (Dr Mary et al), French government and Novartis. Why would the French health minister make an announcement to the effect that the group gave “validated” an effective therapeutic, to say in the next breath, “ Oh, and the Brits in Southampton have a patent on this treatment”. And what is Novartis’s game? Frankly, I just don’t get it!

Argonauts, fair enough. I had misread your motive. Apologies!

Argonauta ... I would get out when you can! 8am tomorrow at the latest!

Well spotted the DT article - good opportunity to build some PR and/or make some subtle points via the comments facility on the piece.

22 July will be the anniversary of the lodging of the Covid-19 patent. This is a significant date, representing the end of the “priority year”. As I understand it (not a patent expert), this year allows time for the company to to obtain more experimental data to support the patent application or to refine aspects of the invention that are likely to be the most important. Data from HT will undoubtedly be filed. It seems uncertain whether any additional findings from ACTIV-2 or P3 will be available against this timescale, although the deadline will surely be concentrating Southampton minds.

ACTIV-2 protocol summary says, “ The study includes both infused and non-infused agents. For infused agents, enrollment will be restricted to participants at higher risk of progression to severe COVID-19. Non-infused agents will be open to participants at both "higher" and "lower" risk of progression to severe COVID-19”

Tonlin, I envy your £1.60 average!

Matterhorn. I was referring to a short thread not here but on Reddit (my mistake!)on Thursday of last week regarding a letter from Therese Coffey, MP, in her capacity as constituency MP of a regular poster on Reddit. It included the paragraph,

"... With regards to SNG001, the Government is greatly encouraged by the preliminary result of this treatment. Initial findings suggest that it could significantly reduce the risk of the disease developing more severely and that hospital admissions could be cut by a third. These are, however, preliminary results. The Department of Health & Social Care has been working constructively with Synairgen to assist them in generating data in support of SNG001 and continues to monitor progress closely."

The discussion there centred round the fact that this could only reference data from the HT study as it made reference to prevention of hospital admission - even if it is difficult to reconcile the statement in the letter with the data published on Friday.

Kevin I, do you think the company was bounced into the RNS and event by the inappropriate release of some confidential information in an MP’s response to a poster on here. I didn’t see the webinar but from what I have read it sounded like an incomplete report on the study - no mention on long Covid, etc. It could be that there was insufficient time to pull together an optimal presentation and certain people were just not available at short notice. Why else would you choose to have an RNS, etc on the Friday before a holiday weekend. Just doesn’t smell right to me. Either was, it seems to have reflected badly on the company’s management.

Excellent find/post, Matml74. The theoretical scientific case for IFN therapy EFFICACY becomes more unassailable by the day. The safety argument ditto. We just need clinical trial validation and a demonstration that the treatment (SNG001) can be manufactured and delivered at scale. Soon!

... of steady flow of fairly chunky buys. In any sane market they would be moving the dial upwards!

Steady flow of chunky buys all afternoon - not moving the dial!

SGD27, credit for the find is due to Mattm1 on Reddit. The comments are mine. Re the huge difference in the number of IUs of beta 1a and 1b, I don’t know the answer. It could be that the scales are different for the 2 variants. Maybe someone on here knows the answer. What would be important is that the authors selected appropriate doses for the 2 versions in the trial.

Posted last night on Reddit: “Nature publication. Role of interferon therapy in severe COVID-19: the COVIFERON randomized controlled trial
https://www.nature.com/articles/s41598-021-86859-y
“ In patients with laboratory-confirmed SARS-CoV-2 infection, as compared with the base therapeutic regiment, the benefit of a significant reduction in TTCI was observed in the IFNß1a arm. This finding needs further confirmation in larger studies.”

It is really interesting and supportive, not only of the general line that IFN 1 has a beneficial effect in Covid-19 but also of the specific case for SNG001.

OK, it is a very small, open label but randomised study, pass the salt please, but, to the extent that it has any validity, there are several key messages in the paper:

1 Patients in both IFN arms seemed to fare better than those in the control arm
2 In the case of the beta 1a arm that superiority was greater and statistically significant whereas in the beta 1b arm it was not.
3 Although the study was not powered to provide statistically valid evidence on mortality, there was a gradient for survival in favour of beta 1a over beta 1b over control. This finding echoes the result in the hospital arm of SG016.
4 These findings were derived with subcutaneous IFN preparations, sub optimal in comparison to nebulised product.
5 Beta 1a is, of course, the form of IFN used in the formulation of SNG001 whereas, critically, beta 1b is the formulation used by Dr Mary and collaborators in Amiens. I have felt for a while that the Amiens operation was the most significant confounding factor in the smooth commercialisation of SNG001. IF the findings in this paper were to be shown, on the basis of further study to be valid, as they relate to the relative performance of 1a and 1b in nebulised form, then the French threat retreats markedly.

So, much food for thought. It would be a mistake to bet the farm on a small and imperfect study like this but, personally, I take comfort from the thrust of its findings.

The sample size chosen for any clinical study is predicated on the number of subjects required to demonstrate a clinically relevant and statistically significant effect. So we should be confident that Synairgen have not chosen a sample side of 120 at random.
My understanding of case hospitalisation rates by age and presence of underlying morbidity suggests to me that the case admission rate would be likely to be around 12-15% in the absence of intervention. Based on this,my expectation is that there could have been around 7-8 admissions in the placebo group. I am also confident that the admissions in the study group could be 3 or less. This would certainly deliver a statistically significant result. That’s as far as this Mystic Meg is prepared to venture!

A lot of talk here tonight about SNG001 working best when “there is a fire to put out“. Whereas I believe that is true, the real test in the HT study will be not what happens to the patients on the active compound but what happens to the patients in the placebo arm of the study. A successful outcome will be the absence of development of severe disease and/or hospital admission, oxygen/ventilator support in patients on 001, compared to a progression in a number of subjects in the placebo arm to more serious disease, both acute in the short term and persistent in the runthrough to 90 days - at a statistically significant level. So, I’m not as pessimistic as some regarding the likely outcome of the study. The nature of the results will be different from those in the hospital study but, in my opinion, still stand to demonstrate clear protection of patients in the 001 group and clear water between the outcomes of the two study groups.

Interesting to hear RM make reference to a “tweaking” of the inpatient P2 protocol to include a 12 month review of patients. I hadn’t heard this before although it is a bit of a no-brainier. This should mean that the patients in the hospital arm of SG16 will be due to undergo a one year review now and in the period up to 28 May. Something else to look forward to in the summer!

Last patient dosed 20 January 2021. LPLV due 20 April. Add 3 weeks for data quality and analysis (as per the timescale list June/July. Takes you to 10 May.