Synairgen Share Discussion Threads

[lunus1] 04/4/2020 20:43

So it looks like we begin recruiting on Monday. As others have said you’d expect an RNS confirming our addition.
hxxps://www.recoverytrial.net/

[nobbygnome] 04/4/2020 20:43

No its the other way round. SNG licensed it to AZ for a while before they gave it back.

[torreskid] 04/4/2020 20:40

Not sure if AZN have or had the patent on the drug formulation (how its made etc) and passed on to SNG

[nobbygnome] 04/4/2020 20:33

>> torreskid

Seven centres I think. Leicester starts on Monday.

[supernumerary] 04/4/2020 20:33

'No other company has inhaled interferon beta in trials as far as I am aware....' I agree your conclusion is most likely correct, but is there patent or other protection to prevent this?

[torreskid] 04/4/2020 20:31

Guys (and gals)
I think recruitment will not be difficult.
Southampton have recruited 6 patients (in 5 days) if we are to believe the twitter message.
I think 10 centres will be involved? It takes a bit of time to start a trial at any one centre, but once started, recruitment will accelerate, so for southampton I anticipate an average of 1 patient per day (weekends do not exist!! diseases have no calender)

So lets try and predict when all 100 patients have been recruited. If we can do so then we have a rough idea of when the trial will stop. (which will be exactly when the last patient has been recruited.

Southampton by end of month should have recruited a minimum of 30 cases. (i believe they will have more by then)
If we assume 3 centres start recruitment next week, then by the end of the month, each should have recruited 15 each (45 cases)
If the other 6 centres start around 15th April, then I anticipate they will make up the shortfall by end of this month (5 cases X 6 new recruiting centres)

Optimistically I anticipate that the last recruit to be randomised into the study will be end of April, and therefore results will be analysed on 16th of May onwards. Most of the data will be available (mainly primary end point and some of the secondary end-points), you just need to unblind and press enter!

At the risk of sounding as exuberant as Likya, this is great news/timing (may coincide with end of lockdown)

[nobbygnome] 04/4/2020 20:22

Interesting the discussions about the trial yesterday did not include SNG001 so it must have been added in the last 24 hours!

[nobbygnome] 04/4/2020 20:17

It is a nebulised version of beta interferon at the same concentration as SNG001 so must be one and the same! No other company has inhaled interferon beta in trials as far as I am aware....

[awise355] 04/4/2020 20:16

I was reading through 22 page doc but couldn't see SnG mentioned specifically, did I miss it?!

[likya123] 04/4/2020 20:03

Nobby, i agree with you on this one, RNS on Monday. This just got much more interesting!

As I keep trying to say, unprecedented times and therefore unprecedented situation.

[nobbygnome] 04/4/2020 19:59

But surely there must be an RNS about this on Monday....

[nobbygnome] 04/4/2020 19:59

And the placebo arm has more patients than the other arms. The randomisation is 2:1:1:1:1 so twice as many on placebo as any of the drugs.

[nobbygnome] 04/4/2020 19:58

>> likya

Don't get too excited. This is a trial with many arms so it will take a while to get enough patients in each arm. It will still be at least 2 months IMHO....

[nobbygnome] 04/4/2020 19:54

So post of the day goes to mdchand without a doubt!

This is worth putting on any other BB such as LSE. I don't use it so if someone else can oblige...

[nobbygnome] 04/4/2020 19:53

Well this study in the protocol highlighted by mdchand has SNG001 as one of the treatment arms. This is an open label study with many arms so the data can be analysed as you go along unlike SG016 the SNG double blind trial. I am somewhat surprised that SNG001 is part of this study and surely it has to be RNSed on Monday morning! This is a highly significant development!

[likya123] 04/4/2020 19:47

Nobby, can you put into laymans terms what we have not been told and should therefore expect to see in a RNS on Monday or early next week?

[nobbygnome] 04/4/2020 19:43

The dose level in the Recovery trial is 6M IU so the same as SNG001 in the SG016 study so it must be SNG.

Very intriguing. Why haven't we heard about this before....

[nobbygnome] 04/4/2020 19:25

>> Likya

Sorry but they just won't unblind it ahead of the result. The recruitment appears to be happening very quickly so perhaps it won't take 2 months but I stress it won't be unblinded until the end. That compromises the data.....

[nobbygnome] 04/4/2020 19:23

>> mdchand

I am a little confused. It seems from that document that SNG are involved in the Recovery trial because it says the interferon beta is nebulised so it must be SNG001. However, I can find no reference to SNG and they haven't said they are involved in this study. RNS on Monday?

Good find BTW...

[likya123] 04/4/2020 19:19

Nobby, have you seen the recent links to the "recovery trials" and the health secretary which seems to be suggeting Synairgen?

Nobby, I have much respect for you and your 2 month time period you've allocated for this trial but I honestly think you're about to be shocked when you see what happens next and the timescale it happens in.

I think it is very interesting to revisit the RNS about the pilot trials and how they can be immediately progressed.

This is no normal trial...this is completely unprecedented!

[mdchand] 04/4/2020 18:35

For those far smarter than me, this link be of interest (apologies if previously posted)

hxxps://www.recoverytrial.net/files/professional-downloads/recovery-protocol-v2-0-2020-03-23.pdf

[nobbygnome] 04/4/2020 18:14

So ańother centre recruiting from Monday which is excellent news. Good find likya.

[3fiona] 04/4/2020 18:07

Good finding- thank you!

[likya123] 04/4/2020 18:01

Current COVID-19 trials

Patients presenting with COVID-19 in our hospitals will be asked to take part in our clinical trials, as we join with national and international colleagues to fight this disease.

Patients will be able to take part in a clinical trial if they meet the inclusion criteria. This means they have been identified as eligible because the trial may best help someone like them.

To help them decide whether they want to take part, a member of staff will explain to them what the study involves. They will also give the person a patient information sheet (PIS). They are under no obligation to say yes, and their standard care will not be affected if they decide not to take part.

ISARIC

We are part of the International Severe Acute Respiratory and Emerging Infection Consortium (ISARIC). As part of this group, we are collecting clinical data and samples from patients who have confirmed COVID-19. By collecting this information we can better understand the disease and use this learning to inform treatment decisions and the wider public health response in our communities.

STATUS: open to recruitment

Visit www.isaric.tghn.org

RECOVERY

There are currently no proven treatments for COVID-19. In this clinical trial, patients with confirmed COVID-19 will be given one of three different medicines that have been used to treat other conditions, such as HIV, to see if they provide any benefits. This will help healthcare professionals decide if these treatments should be given in future.

This is an adaptive study, which means new therapies can be added to the trial as they become available.

STATUS: open to recruitment

Visit: www.recoverytrial.net

SARS Cov-2 infection study

In this clinical trial, patients who have confirmed COVID-19 and pneumonia will be given either a nebulised version of interferon beta (a naturally-occurring protein that supports anti-viral responses in the body) or a placebo (‘dummy’ medicine).

STATUS: Sponsor green light; due to start recruiting 06.04.20

Visit: www.synairgen.com/covid-19/