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Thanks
Matterhorn, It's a unique situation and the Activ trial is quite unique in itself, the way it is being run. I believe they will still run with Regeneron and like you say compare against the existing data generated. I can't see how they have any other choice unless there is another MAb that shows no loss of efficacy against omicron which they can swap in as comparator.
Matml74 - hypothetical question for you if you don’t mind. My response to Blue83 was (probably) a bit far fetched.
Let’s assume Regeneron’s mAbs are ineffective against omicron and there’s no alternative except a placebo, but you don’t want to go down that route. In the world of trials would it be conceivable to continue the trial without practically having an active comparator, for the reasons mentioned, alongside the trial drug, but you compare the trial drug’s results against the active comparator’s results achieved against a previous variant? Also assume the inclusion & exclusion criteria are the same.
I’m not suggesting this might happen or advocate this. Purely just a question out of curiosity of what could be possible.
Thanks, sounds less concerning.
I have just finished a course on clinical trails. I was surprised at their approach to losses and changes in protocol. In my previous experience (in finance) we have always been able to extend a sample & not think about comparative tests or attributing losses in a comparative situation.
Blue,
Activ 2 P2 SNG001 was trialled against placebo.
Activ 2 P3 SNG001 is trialled against comparator - Regeneron.
As of today I believe Activ 2 P3 for SNG001 has not yet begun enrolment so there will be no starting again. I expect that Regeneron will continue as the comparator unless it is shown to be completely ineffective against omicron. The idea of trialling against a comparator is to continually improve on your SOC options not taking into account the ethical issues around placebo use. We can only go on what is in the protocol at present and I guess we will find out more in the next week or so wrt all the MAb's.
We should all know that the drug is not targeting a specific virus, let alone a specific variant of a given virus. It was concocted well before COVID-19.
Why can't they just split the results between the different varients? Would that be seen as diluting the final statistics.
Blue83 - Matml74 is more qualified to answer your question, although I’ll share my view. I did think about this a bit further since my post and I’d guess Regeneron’s results can still be used as a benchmark even though it was against a different variant. Any new drug to be trialled would need to perform equally or better against the new variant than what Regeneron achieved against a previous variant.
For SAB it could mean that their MAbs treatment potentially gets removed from phase III.
Matterhorn & Matml74 - have a point posted at 12.38 above - copied below.
What happens in a test if the comparator is pulled out? A trail has to have a control group, is the comparator the control rather than a placebo in ACTIV3? Start ACTIV3 again? hope not!
"following on from your comment. I guess it’s too early to say as we can’t yet definitively say omicron will outdo delta. But, should that be the case then it would have significant implications for ACTIV-2 phase III. If Regeneron’s mAbs are ineffective it would not make sense using it as an active comparator. And, if SAB’s mAbs are also ineffective, which is possible, then why still trial them in phase III. That leaves SNG all be itself."
Mystic Meg seems to have got it wrong AJ316 -
“ Mystic megs back, called it last time bang on the money not said it since but ’ve got that feeling again. RNS inbound tomorrow morning heard it here first.”
I suppose you still have 2 hours to prove us wrong!
Mystic megs back, called it last time bang on the money not said it since but ’ve got that feeling again. RNS inbound tomorrow morning heard it here first.
Mr Costs the SNG formulation is generic. If the market doesn't know this then it (the market) should do more research.
You can guarantee every senior government scientist on both sides of the pond is absolutely aware of the risks of escape variants to treatments and of the advantage of a variant agnostic therapeutic should our results be as good as P2
I seem to recall that the PPE order from Turkey was faulty.
Your evidence regarding pre orders. Surly Synairgen are taking a risk by making product which may not be saleabile
SNG wont release any information regarding the variants as they are most likely in talks/discussions with a major and like someone has just said "you don't show your hand"
Gold
Why would synairgen lay bare all their cards on the table at this point ,Sure ,get approvals and orders and repay the shareholders then let someone else decide if. 001 is less effective than other drugs .
Don't see Az ,Moderna ,gillead,etc lining up virus mutations just to prove their drugs don't really work .
City. Absolutely. Different variants have been tested in a labortory environment by Synairgen and Sng001 has proved very successful.
Boris Johnson's is doing another press conference later today. Should be interesting.
CityTTrader - I get that but does the market know this? Would an update do any harm? Big pharma will always roll out the band with the hint of any good news, SNG need to grab this opportunity.
We seem to be on the only covid company in the entire world who hasn't had any pre orders...
Even a Turkish PPE company managed to obtain orders from the government.
SNG have repeatedly stated that SNG001 is effective on all current and future varients. If you need to confirm this then you can call Tel: 023 8051 2800
Matml74 - following on from your comment. I guess it’s too early to say as we can’t yet definitively say omicron will outdo delta. But, should that be the case then it would have significant implications for ACTIV-2 phase III. If Regeneron’s mAbs are ineffective it would not make sense using it as an active comparator. And, if SAB’s mAbs are also ineffective, which is possible, then why still trial them in phase III. That leaves SNG all be itself.
Why have SNG not released an update saying they are confident their treatment will work against Omicron?
This is the SNG comparator treatment for Activ 2 P3 at present! The case for a rapid EUA for SNG in hospitalised patients is growing by the day.
https://www.wsj.com/articles/covid-19-antibody-drugs-are-challenged-by-omicron-preliminary-testing-indicates-11638270003?mod=latest_headlines
'Preliminary tests indicate the Covid-19 antibody drug ****tail from Regeneron Pharmaceuticals Inc. loses effectiveness against Omicron, the company said Tuesday, a sign that some products in an important class of therapies might need modifying if the new strain becomes widespread.'
Separate testing of another authorized Covid-19 antibody drug ****tail, from Eli Lilly & Co., indicates it also isn’t as effective against Omicron, outside scientists said. Lilly said it is testing the new variant against its antibody treatment and wouldn’t speculate on what the results will be.
The findings are the early results of researchers’ race to assess the impact of the new Omicron variant on Covid-19 treatments that patients, doctors and hospitals have been relying on, as well as pills in development that have promised to keep people out of the hospital.
Researchers say some antibody therapies are likely to be especially vulnerable to Omicron because it contains mutations to the spike protein that the Regeneron and Lilly drugs target, while other drugs should hold up well because they attack elements of the virus unchanged in the variant.'