Member Info for JoeyDiamond

https://clinicaltrials.gov/ct2/show/NCT04552379

For anyone interested this is the IFN-B Chile trial involving Professor Eleanor Fish.

The results from the AZN trial appear good, again selective data readouts to maximise the numbers but a good result on paper. Like the other vaccines should be peer reviewed and full data made public.

If they do manage to get the 90% number (very odd a half dose makes efficacy go from 62% to 90%) after more testing then that spells trouble for Pfizer and Moderna. The AZN vaccine is 5-10 times cheaper and can be transported easy without the need for the cold storage etc. Their CEOs bailed at the peak makes we wonder if they had advance knowledge.

However questions remain.
a) Effiacy based on N=131. This is a low number, will more data reduce effiacy?
b) Many adverse events in the trial but all were explained away as no vaccine related? This is odd need to see data.
c) Explain why a half dose makes such a difference?
d) Immunity measured after 2 weeks which is peak time. What happens after 3 months etc?

I was thinking about individual countries, the WHO and the people responsible for planning prevention strategies for Covid-19. How will they go about preventing a 3rd wave? What strategy will be in play? How do you defend against the virus mutating and how do you mitigate this risk?

Then you think about the big difference between SNG001 and vaccines/mAbs in the way they work. SNG001 is a broad spectrum antiviral.

Vaccines and monoclonal antibodies specifically target the spike protein area of the virus. Essentially the idea is you neutralise the ability of the virus to infect by blocking the binding of the host cell receptor and spike protein of the virus. With this method being very selective and targeted it should be very successful in preventing disease.

However if there is a mutation of the spike protein it could prevent vaccines and mAbs from working effectively. The Phizer vaccine creator has said he believes there is a very small chance like 1-2% chance a mutation renders the vaccine ineffective, they are now testing the vaccine against mink and other mutated forms currently.

mAbs on the other hand can be very impacted by a spike protein mutation as they use 1 targeted and selected synthetic antibody. Scientists recognised this issue early on so the Covid-19 mAbs are designed using 2 different antibodies. Idea being if one is rendered ineffective by the virus the other antibody still works. However we have seen one mutated strain of the virus already become resistant to both of the antibodies in one of the well known mAbs treatments. As time gos on we could find more mAbs treatments become less effective. I think a mAbs treatment with 3 different antibodies would be a good way to go as that would pretty much stop the mutation chance altogether.

Scientists also say as the virus existence becomes under threat by vaccines/treatments it will likely mutate more to survive, this is normal in nature. With more mutations the chances of some vaccines/treaments becoming ineffective would increase. We also have the chance of a Covid-20 meaning all vaccines/mabs become inffective.

So what does this mean for pandemic planning and risk mitigation for the future?

Simply you need to defend against all potential outcomes and mitigate risks no matter how small they are. Would 90% risk mitigation be enough in a worldwide pandemic? Would 95%? etc

You will need a different treatment that is not as targeted in case of mutations and in case some people do not respond well to the vaccine/mabs. A broad spectrum drug is required as another option, one that is likely effective against all mutations of a virus.

If you were in charge of a country or WHO pandemic response would you just say yep we will just take a mAbs treatment or would you have multiple different treatments in the cupboard to mitigate risks?

I think sensible forward looking countries would like to have SNG001 in the arsenal to go alongside thei

Cravo doesnt hold SNG it was just an IMM ramp post.

SNG raised the cash for the P3 trials which would include the cost of providing 600 treatments.

https://www.who.int/news-room/feature-stories/detail/who-recommends-against-the-use-of-remdesivir-in-covid-19-patients

The scam of Remedesivir finally put to bed. No more profiteering on dodgy data.

https://www.washingtonpost.com/world/asia_pacific/coronavirus-vaccine-china-trial-sinovac/2020/11/18/4e47b0fe-294f-11eb-9c21-3cc501d0981f_story.html

While the vaccine appeared to be safe in these early clinical trials, the company reported that it generated lower levels of protective antibodies in the bloodstream compared with those arising in recovered coronavirus patients.

https://www.nih.gov/research-training/medical-research-initiatives/activ/covid-19-therapeutics-prioritized-testing-clinical-trials#activ1

This gives an overview of all the drugs on the US national trials (equivalent to Recovery trial in UK). Handy summary.

Thats the original phase 2 trial for SNG001.

Sadly no mention of Synairgen on the Activ-2 trial, then again neither is MK-4482
https://www.clinicaltrials.gov/ct2/show/NCT04518410

MK-4482 has its own trial here
https://www.clinicaltrials.gov/ct2/show/NCT04575597

That was the equivalent of the Stephen Holgate lecture on interferon. Concludes that inhaled interferon should be use to deal with all viruses, not just covid but for future viruses too.

Interesting Eleanor is starting a new interferon trial in Santiago, Chile tomorrow. The idea of the trial is to give interferon as a preventative measure to entire households.

If 1 member of the household tests postive via PCR test, then the whole household is given interferon straight away as a preventative at day 1, day 6 and day 11. So 3 doses.

They will see if disease is prevented from worsening across the entire family amongst other endpoints. You can imagine if results are great here makes sense to do the same action in care homes.

The biggest point was she is using an injectable form of interferon for the new trial but really wants an inhaled form. She mentioned she has been in touch with Synairgen about the trial and they have shown interest in using their inhaled form of the drug.

Potentially we will have partnership with Eleanor in a new preventative trial.

For anyone who enjoyed Pro Ste Holgates lecture I would recommend everyone to watch if there is a replay as the information on detail about interferon was fantastic.

Dr Eleanor Fish too - an expert in interferons

Exactly Dibs61 if just one country produces an EUA then the pressure mounts on all the other countries.

Does also went to his least favourite daughter

A truly international trial is a master stroke.

Each individual country has its own regulator and rules to make a decision on EUA. Some countries will apply an EUA on less stringent data ie India. We also have MAP in place with Clinigen so a ready supply of the drug is available although limited supply.

Knowing there is such limited supply how long will some countries want to wait before granting an EUA? Wait to long and there may be no supply.

So the DMC will no doubt be requested to provide updates to countries and regulators on a very regular basis. If there is efficacy even at say 300 patients some countries they may well say thats enough data for us. No time to wait. Will USA want to lose out to Russia ;)

RM playing FOMO with 26 countries maybe? Dam interesting months ahead.

I was not expecting Russia to be on the list :0

https://ccf-nihr.zoom.us/webinar/register/WN_KZLwXfmUQaS3Cu0-UU48Zw

Nov 30, 2020 04:30 PM

This should be in everyones calendar - I persume you mean this one RScorpio?

We are talking about a corrupt UK government and their 'elite' scientists. I really doubt ethics have never been part of their decision making, making big profits has always come first.

I suspect SNG001 going on recovery trial would give it far too much advertising and would reduce experimental vaccine uptake amongst the population.

If the public find out we have an effective therapy then why risk an untested vaccine.

There can be no other sensible explanation why for a 2nd time SNG001 hasn't made the recovery trial. Pre vaccine news Recovery/CTAP requested synairgen make a request for admission to the trial (MP response on this board).

India deal - Nope, suspected rumour comes from a Drs twitter account in India when they were discussing trials.

SG017 special hidden trial - Just an Internal biomarker inhouse trial now discontinued. Boring.

P3 trial has started!- Not yet, he said a couple of weeks which I estimate most likely Mon 30 Nov or Tues 1st Dec.

Trial Duration will be 1 year! - Best case 2 months - can be up to 4 months.

Government have been hampering progress - Not the case, various agencies have been helpful.

FDA making trial harder by making all patients be at Ord scale 4 - This was Synairgens choice.

Clinigen will sell loads via MAP - Very few enquiries, MAP has been setup if we get an EUA to distribute the drug. No data can be obtained from this route, only data from trial can be used for full approval.

RM and Synairgen have fast broadband - No they still uses 56k dial up modems