The latest Investing Matters Podcast episode featuring Alex Schlich, founder and managing director of Yellowstone Advisory, has just been released. Listen here.
We’ve had scientific articles on Interferons covering
mRNA enhancement extending vaccine protection
There are many exciting areas for this drug, which explains why Poly are still involved and why Activ didn’t just drop our drug.
We see so much good news and interesting science that’s seems to get lost. I know a number of us on this board and other boards are continually sharing these items with Richard and his team. Good to see they’re hiring someone to promote it
Early intervention is not the best route for sng001. The drug is too expensive to throw at patients who “might” go on to suffer hospitalisation. We also have two pills already in that arena.
SNG001 shows a tremendous benefit in hospitalised patients where they’re showing respiratory decline and where the drug options for intervention are very limited. It’s the best cost / benefit route with the least competition
It’s interesting what she says but we still have to remember what the board said at the AGM.
The drug is unlikely to go to market within the next 12 months. Their focus is on further trials which tends to suggest they’re not currently looking at any kind of EUA.
Whether that would or could change off the back of Activ data or some form of new design criteria is anyones guess.
It does at least suggest that NIH and the FDA are looking at a wider range of approval criteria than just phase 3 endpoints and clearly recognise the difficulty in producing a trial of sufficient power to demonstrate efficacy of some drugs in this new world of changing variants, the ebb and flow of Covid-19 waves during trials and the changing landscape of SOC.
It certainly has the potential to be positive for Synairgen given their subgroup analysis and ATS presentation.
Get the nod for EUA application by FDA and MHRA
Off the back of roughly 200 patients but questions remain over the balance of placebo vs drug after a very high 45% mortality in the placebo arm. Far higher than is usual in a control group.
The full data on patients will be interesting
A lot of the focus was lost on Friday because of the usual suspects trying to promote a conspiracy theory around SNG001 missing from a slide. Primarily driven by the great Straw Man poster on this board who likes to build up a force narrative. Claim it’s fact and then shoot it down as being wrong.
In all that confusion we missed something that actually is very important in what Stacey actually presented.
41min in on the outpatient slide she discusses the way forward for outpatient subgroup and how they are looking at the potential of combining Meta Analysis as Surrogate End points.
This feeds into something I’ve mentioned a number of times on this board regarding ways in which the FDA looks at drug approvals.
examination of data from a number of independent studies of the same subject, in order to determine overall trends.
A surrogate endpoint
Used for accelerated approval is a marker - a laboratory measurement, radiographic image, physical sign or other measure that is thought to predict clinical benefit, but is not itself a measure of clinical benefit.
A stand out of this slide package that caught my eye is the agent prioritisation slide.
“Is the agent part of another robust trial”
“Remove from Activ trial consideration”
This clearly shows how NIH are focussed on progressing drugs in trials and an investment in time, resources and money that demonstrate their platforms value in the fight against Covid-19
One of the key reasons in my view why they won’t give up our Activ data until they’ve decided how it fits into their ongoing work
In the US approximately half of the 4 million newborns are infected during their first winter with 1-3% hospitalized and an additional 4-7% and 10-16% seen in emergency departments or physician offices, respectively, for RSV infections
RSV causes 118 thousand deaths, 6 million cases of severe acute lower respiratory illness and 3 million hospitalizations in children under 5 years of age
Insufficiency in airway interferon activation defines clinical severity to infant RSV infection
Blocking interferon signaling enhances RSV infection of primary pediatric human lung epithelial cells.
IFN treatment blocks the number and size of infection plaques, as well as the production of viral transcript, while blocking IFN signaling is sufficient to potentiate infection
Mathematical Modeling Finds Disparate Interferon Production Rates Drive Strain-Specific Immunodynamics during Deadly Influenza Infection
Studies suggest that the timing of the type-I interferon response is key in limiting viral replication and recruiting an appropriate pro-inflammatory response [38,39,40]. Induction of interferon production is also partially responsible for regulating the activity of innate immune cells such as macrophages and neutrophils
Although it remains unclear how H5N1 and other highly pathogenic viruses induce a more severe inflammatory response, there are several potential explanations. One possibility is that H5N1 viruses replicate more quickly, and that observed differences in the immune response are driven primarily by the viral replication rate . Another possibility is that H5N1 viruses may antagonize the immune system differently during the early stages of infection. A specific candidate mechanism involves the influenza virus’ nonstructural protein 1 (NS1). NS1 is well-established as an antagonist of intracellular immune signaling through the inhibition of retinoic acid-inducible gene I (RIG-I) activity, which leads to a delayed type-I interferon response
This article continues the theme in the benefits of early interferon response in RSV virus
https://pubmed.ncbi.nlm.nih.gov › ...RIG-I activation inhibits human respiratory syncytial virus ... - PubMed
The type I IFN response is the first-line defense mechanism against invading viruses, including ASFV (18). Therefore, viruses have evolved diverse antagonistic strategies to evade the type I IFN response and facilitate rapid replication in host cells (19). The virulent ASFV strain Armenia/07 has been shown to inhibit IFN-ß production
African swine fever
This is what I posted about the ATS review. You’d think the guy would at least learn to copy and paste properly.
RE: ATS 2022 Conference Report20 Jul 2022 11:37
Those findings have just been published and peer reviewed in an article from one the worlds leading respiratory organisations
But as per usual he rewords things to spread his typical half truths. The publication clearly states the article has been peer reviewed. He’s either blind or stupid.
But typically docdaneeka tries to turn a good story about our drug being top of the list of items they talk about in their publication, into a stupid argument about peer review. Just as he tries to turn a great post about Strive into a stupid argument about sng001 missing from a slide when it was clearly listed on another slide. He suggests there’s some issue with sng001 being on an inpatient trial because it’s been on an outpatient trial.
The guy is full of smoke and mirrors designed to displace good news and he’s got lots of form in telling these half truths and misrepresenting peoples posts
Typically full of more mistruths but to be expected.
The ATS article was peer reviewed by the editors. No one said it was a scientific paper or reviewed in such but just like so many of your comments, you rewrite them to suit your own agenda and then present them as fact, they’re only fact in your imagination.
I use to think you’d made a mistake in the way you posted your comments or misrepresented facts but I’ve seen it so often it’s clear it’s your standard operation and agenda.
You stated that Synairgen have no interest in pursuing Covid for their drug. Absolute nonsense.
Then you stated Strive is not a multi viral trial platform when clearly they’re looking at multiple viruses. I suggest you google multi-viral (more than one
You come on here purely to create arguments, and insult people, it’s in so many of your posts over the last two years, I’ve lost count.
Here’s another example of the nonsense you post
“If your interpretation was correct then SNG would be the only ever trialist on this platform - unless other Ifn therapies were also to be tested”
It’s merely your twisting interpretation of what people post to suit your own argumentative views.
What you’ve shown evidence of is drugs on a phase 2/phase 3 trial doing p2/p3 phases. You make it sound as though that a revelation about how Activ works, it isn’t.
For someone who described one of my statements as the most “pathetic he’d ever read” you really should look in the mirror
“ All 8 of the Activ 2 trialists took exactly the same route as SNG with P2 followed by P3. ”
Given Activ2 was a phase 2, phase 3 trial that’s hardly surprising that drugs on that trial went through both phases.
But completely misses the point that any drug that’s a candidate for inpatient trial can as in Activ be part of a purely phase 3 trial.
Can sng001 jump from from outpatient to inpatient, of course it can. In fact it would be ridiculous to suggest that just because a drug has been tested in outpatient it can’t be considered In inpatient trials.
Drugs are assigned on the merits of their likely effectiveness in the environment they’re being considered for given the available knowledge of how they work. Sng001 isn’t locked into only working in non hospitalised patients.
Let’s look at the criteria:
Strive is looking for drugs to prevent death or severe illness in inpatient setting. SNG001 has shown 70% efficacy. That by quite a large margin is one of the best figures of any trialled inpatient drug.
Drugs to prevent Long Covid-19. Research shows
Dysfunctional IFN response leads to LC in elderly and immunosuppressed patients. SNG data shows they’re the most likely responder group to our drug.
Strive is looking multi viral therapeutics. SNG is recognised through its mechanism of action as a potential treatment for a wide range of respiratory viruses.
Before anyone says “show me where sng001 is linked to strive”
Well if you can’t join the dots and see a picture perhaps you should try specsavers!