Synairgen Share Discussion Threads

[sharestingoriginal] 03/5/2020 08:53

Hi NobbyI believe that hospital data can be shared with Synairgen only. The patient / consultants coordinating the trial are blind and rightly so. The at home trial is very much early intervention focussed. Learnings from the COPD and Asthma trials show the drug works best at first signal (sore throat / cough ...). With only 125 patients involved in the double blind trial this could happen very quickly, especially with much increased awareness around SNG001. I believe positive signals will be taken from the hospital trials, which will allow progression of the MHRA and FDA regulatory application.

[sharestingoriginal] 03/5/2020 08:40

Please all ask a question regarding SNG001 and the first UK at home drug treatment trials. [e-mail]

[wetdream] 03/5/2020 08:00

Sounds like Boris scored 5. ‘Litres of oxygen’ administered.
8-/

[nobbygnome] 03/5/2020 07:20

A link to the ordinal scale is below; it's on page 6 of the document. It doesn't refer to hypoxia but the use of oxygen which is still the primary treatment as far as I know. As I have previously said it is a good endpoint in my view because it enables data to be analysed in multiple ways which increases the chance of seeing a statistically significant result.

[nobbygnome] 03/5/2020 07:05

>> hms_trader

As previously discussed, no-one will know the results yet because the trial is still blinded so how could that affect their thinking. I am not sure how many times I have said that now. My understanding is that the major thinking behind this trial was it could enable them to get the treatment into care homes as well as hospital. After all that is where the major need is at present and will be in the future.

[amaretto1] 03/5/2020 06:55

Stop worrying yourself.

[lithological heterogeneities] 03/5/2020 03:18

Sky News tweet

[hms_trader] 03/5/2020 01:49

I have seen posts on LSE suggesting a different angle to what is understood regarding the Home Trials on here. The view is that the reason for the Home Trials is that perhaps the drug was found not to be as effective in the hospitals due to patients being identified as infected too late in the cycle for it to make a difference thus the aim to get it into the Home was to get the patient at an earlier stage to determine whether the drug may have greater efficacy at that point.

Nobby - what are your views on this being the case?

Thanks

[torreskid] 02/5/2020 22:56

Below are the Primary and secondary points being measured in SG016 trial.
It is all about demonstrating an improvement in managing the patients being admitted into hospital (You are only admitted if you have a fever and/or new cough PLUS HYPOXIA (low oxygen levels), so currently, some improve after admission, but a lot deteriorate. There are many measures of 'deterioration', and these are noted below.

The Primary end point is the Ordinal Scale which although 'complex' is relatively 'precise'/reliable in relation to breathlessness and hypoxia (the only fly in the ointment, is that since the study was approved, the medical knowledge has improved (wrt covid) with the strange phenomena of disproportionately low oxygen level to the 'symptom' of breathlessness (ie patient should be more breathless than they are-- just an interesting observation which may 'cloud' the Ordinal scale measures (cos you will be given oxygen even though you dont feel breathless)

Measures include
1)Change in condition measured using the Ordinal Scale for Clinical Improvement during the dosing period.

Progression to pneumonia as diagnosed by chest x-ray, if no pneumonia is present
at time of enrolment
b. Evolution of pneumonia, as diagnosed by chest x-ray, if pneumonia is present at
time of enrolment
c. Time to clinical resolution ≥4 of 5 vital signs (temperature, O2 sats, Resp
rate, heart rate, systolic blood pressure).
d. LRT Symptoms (Changes in daily symptoms breathlessness, cough and sputum scale
(BCSS) symptoms score during the study period (including disaggregated scores))
e. Virus clearance/load
f. Safety and tolerability
g. Blood and sputum biomarkers if samples are available

The biomarkers collected will help identify/support the 'mechanism' by which SG001 'works'- They will look for reduction in 'viral load' as the 'reason' but even if there is improvement without reduction in viral load then this is not a bad thing

Getting excited as the recruitment for pilot is nearing the end... results will be hotly anticipated by many

for the record, this is not the cure or a magic bullet

[crookie3634] 02/5/2020 22:11

Welcome ShareSting, no prizes for guessing my guise on LSE.

Good to have you onboard.

[sharestingoriginal] 02/5/2020 21:54

Hello all I am sharesting from LSE. Nobby I have just downloaded the app. This is actually pretty cool. Catch up tomorrow for a chat.

[lithological heterogeneities] 02/5/2020 20:59

Sky News tweet

[aquilla] 02/5/2020 20:34

The piece from Sky News.
The presenter mentioned that the search is on for a vaccine but that that could be 12 to 18 months away. Laura Bundock then came on and talked about the various treatments undergoing research. Blood plasma therapy...anti viral drugs including Remdesivir. Then SNG001 was given a mention: "a respiratory drug being tested on patients with lung disease, asthma and multiple sclerosis."

[crookie3634] 02/5/2020 20:32

hxxps://www.who.int/blueprint/priority-diseases/key-action/COVID-19_Treatment_Trial_Design_Master_Protocol_synopsis_Final_18022020.pdf

WHO Scale that we are being measured against. Interesting point in there regarding recruitment and data being used from the pilot study straight away and added into the pivotal stage.

[crookie3634] 02/5/2020 20:15

Nobby this Q might be best for you, how much significance does the WHO ordinal scale need to show to get the trial progressed? Or is it that in current situation as long as it is safe and shows some level of improvement in patients it could get progressed? I am interested as having read the previous COPD document it showed improvements but not in all categories so interested to what people think might be required for the regulators to approve it? I get a feeling as long as it is safe and shows some improvements on patients they would pass it. Like others have said it will be one of many treatments so wondering if they will be more lenient in the current crisis?

[lithological heterogeneities] 02/5/2020 20:13

markinvestor

Great find !

[markinvestor] 02/5/2020 19:50

Apologies if this has already been posted. An interesting article on Interferon Beta released yesterday

[wetdream] 02/5/2020 18:50

Nobbygnome,

Re ‘early data’ - thanks.

[lithological heterogeneities] 02/5/2020 18:34

Synairgens time will come next month.Huge Worldwide publicity.Huge share price rises.Mkt Cap still stupidly low .

[lithological heterogeneities] 02/5/2020 18:32

I just saw it myself on Sky News at 18:15 as a brief mention when talking about Remdesivir So watch Sky News again between 19:10 to 19:20 as will probably be repeated.

[lithological heterogeneities] 02/5/2020 17:58

We both did !

But it WAS on Sky News. Only mentioned by SNG001 while talking about Remdesivir apparently. Did not see it.

Just wait till it's on ALL the TV channels in the World next month as the main story !

[lithological heterogeneities] 02/5/2020 17:56

So it WAS just on Sky News.

[lithological heterogeneities] 02/5/2020 17:56

From "Vanv" just now, who saw it on sky news 20 mins ago:

VanV

RE: skyToday 17:55
the article might be two months old, but Sky News 20 minutes ago mentioned SNG001 during its report on Remdesivir.

[joyfulcornet] 02/5/2020 17:55

This is dated Thursday 19thMarch