Synairgen Share Discussion Threads

[amaretto1] 19/4/2020 11:43

What vacciteck got to do with synairgen ?

[nobbygnome] 19/4/2020 11:38

So for each patient you will effectively get a discontinuous curve based on the reading every day. So there are numerous ways you can compare that sort of data.

[nobbygnome] 19/4/2020 11:35

A reminder of the ordinal scale....

[nobbygnome] 19/4/2020 11:32

>> Mostro

I am not the slightest surprised that she will be looking to make some money out of it; I would if I was her. I think it is good to see academia and the private sector coming together. Not a problem for me!

[nobbygnome] 19/4/2020 11:31

>> toffee

The first thing to say is that there are many ways the ordinal scale data can be compared. Now stats are not my strong point so exactly which test is appropriate in this case, I would not like to guess. I will leave that to a statistician; the CRO they are using will have someone who is an expert in this sort of analysis.

In terms of statistical significance I paste below a link to a site where you can do some power calculations and can play around with some numbers. Don't forget that a number of patients in the placebo group will improve too so don't put 0 in that group. However, you can get an idea of the sort of difference you need to see to get statistical significance.

[toffeeman] 19/4/2020 11:24

Morning Nobster

If we have a two - arm trial with 50 people in each arm and we are measuring response on a 7 point scale, we will be looking at the mean and standard deviation in both arms.

What difference in means will be required to demonstrate statistical significance?

Off for a walk.

Best

[mostro] 19/4/2020 11:17

Morning Nobbygnome, hope you are having a good weekend!!

Just watched the very intelligent Dr Sarah Gilbert on the Andrew Marr show.. Some interesting comments on problems with production time/success of any vaccine.. How they are doing their best at Oxford to get something in place by September.

The bit I liked came at the end.. When asked who owns any vaccine Oxford may produce ( and therefore whom would make money on any success ) Dr Gilbert said it was a sort of venture between Oxford Uni and a 'small spin-off Company called Vaccitech' and that Oxford University was not looking to make any money out of any of this.... (Debatable at best).. What was not added however, was that the small spinoff business called Vaccitech was co-founded and is currently directed by (among others) our very own Dr Sarah Gilbert.. Dr Gilbert was not asked if Vaccitech was looking to make money on any vaccine success as the answer would have been pretty obvious.
I cannot help feeling something smells bad here..!!

Any Thoughts?

All Best and full Steam ahead next week.

[cambradjones] 19/4/2020 10:58

One things for certain, in the next week or two this is going to start moving sharply north as we get nearer to the results of the trial. I expect pi,s looking to take a position are watching closely for any sign the rerate has started and when it does I'm expecting you won't see the share price for dust.Of course some will derisk by taking some of the table as we get close to results, but I'm sure by then we will be well over a pound.On a positive trial result, blue sky predictions !!!

[nobbygnome] 19/4/2020 10:32

Depends on the reason. If it was for a bad reason then the chances are all patients would stop dosing straight away. If for a good reason, then the ones currently dosing would probably continue. Of course quite often once patients finish dosing they go into an open label extension so that would probably continue even if the main trial was 'paused'.

[wetdream] 19/4/2020 10:24

Just out of interest, how do you ‘pause’ a trial?
What happens to the patients?

[2nell] 19/4/2020 10:20

Many thanks Nobby.

One thing on that result was,if it was taken early on the benefits were significantly
better.

[nobbygnome] 19/4/2020 10:10

>> 2nell

That data was generated in vitro in culture. From my own experience, I know data generated in vitro does not necessarily translate into the same result in vivo sadly. But yes that data is encouraging.....

[2nell] 19/4/2020 10:06

Morning Nobby

I know the COPD trial is still ongoing, but would the data produced below not have the same outcome in this trail?

Measurements and Main Results: Adding IFN-β to MDMs, alveolar macrophages, and PBECs prior to, but not after, infection reduced the percentage of nucleoprotein 1–positive cells by 85, 56, and 66%, respectively (P < 0.05). Inhibition of infection lasted for 24 hours after removal of IFN-β and was maintained albeit reduced up to 1 week in MDMs and 72 hours in PBECs; this was similar between healthy control subjects and patients with COPD. IFN-β did not induce inflammatory cytokine production by MDMs or PBECs but reduced influenza-induced IL-1β production by PBECs.

[myst1] 19/4/2020 09:48

Thanks Nobby,

I think I understand.

I'm confident on the results based on my research, but if we just miss the <0.05 level using the ordinal scale there is still a chance that the regulators will still be interested. (I'm sure they wouldn't dismiss it in that scenario with so much at stake!). From that point of view therefore, it is not so much a binary result compared to normal times and it would have to be given a chance, which perhaps reduces any risk a little?

[likya123] 19/4/2020 09:32

From lse board..

16 Apr 2020
Interferons Global Market Report 2020-30


The global interferons market is expected to grow from $6.9 billion in 2019 to about $7.5 billion in 2020 due to an increase in demand for the use of interferons along with antiretrovirals and anti-malerial drugs in the treatment of Covid-19 patients. The market is expected to stabilize and reach $8.1 billion at a CAGR of 4% through 2023.

The pandemic outbreak of corona virus is expected to drive the growth of interferons market. This is because of the ongoing trials on various drug candidates including interferons as potential therapeutic options for covid-19 treatment. Interferon-beta (IFN-beta) is a naturally occurring protein that controls the body’s antiviral responses. The drug regulators including the Medicines and Healthcare products Regulatory Agency (MHRA) and Health Research Authority (HRA) have approved the initiation of trials evaluating interferons. For example, SNG001 which is an inhalation formulation of interferon-beta-1a that is delivered to the lungs directly via nebulization.

The therapeutic potential of interferon biosimilars for hepatitis and cancer, coupled with the ongoing studies on interferon biosimilars to have prophylactic or therapeutic effectiveness in SARS (severe acute respiratory syndrome), influenza or another virus pandemic, is contributing to the increasing adoption of interferon biosimilars over expensive biologics.

Global interferon drugs market is projected to grow at a rapid pace in the next few years due to the increasing incidence of chronic diseases such as hepatitis-B, hepatitis-C, cancer and multiple sclerosis, the use of interferons in combinational therapies, and advent of novel drug delivery systems. 

The use of interferons in combinational therapies, and advent of novel drug delivery systems is therefore expected to drive the market for interferons. Interferons are also being tested for their use in the treatment of COVID-19.

[nobbygnome] 19/4/2020 09:21

Good questions!

A positive result will be a statistically significant result (a p value of < 0.05) using the ordinal scale which is the primary endpoint. Now the results from the ordinal scale can be sliced and diced in any number of ways (as confirmed by Richard Marsden the CEO) which increases the chance of being able to see some statistically significant result. The drug has been delivered to lots of people already in various trials with a very benign safety record so I would be very surprised if there are any safety issues.

And yes although on the face of it we are waiting for a binary result, I think there is a chance of a middle result in two ways. Firstly if on a number of endpoints derived from the ordinal scale the p value just misses the < 0.05 level, that may be enough for regulators to be interested. There are only 50 patients per group so the study is not powered to see relatively small differences. And to that end the COPD study may well produce a statistically significant result even if SG016 doesn't because it has more patients and in a way is a more controlled study.

Happy to explain more if any of that isn't clear.

[myst1] 19/4/2020 09:06

Hi Nobby, great thread.

Maybe a silly question about the results of the trial, but what is the definition of a positive result?

Do 100% of volunteers need to show an improvement/ recovery?

Do a certain percentage need to show an improvement/ recovery?

What if we achieve 100% recovery but report certain side effects?

Will the ultimate result be either success or failure or could there be something in the middle?

[best1467] 19/4/2020 07:53

Ref result date we will get RNS notifying last patient recruited so at that point with the ergency in mind we have the two week treatment I would imagine within a week of that.
So it all hinges on the last patient RNS, Am slightly surprised we have not had a number update already

[imjustdandy] 19/4/2020 07:49

SNG will be a covid 19 winner that I'm sure of.

[imjustdandy] 19/4/2020 07:47

I believe we fit these 2 new schemes plus we are eligible for a loan. However, the 2 grants are more attractive than a loan. R&D and fund match. Bring it on tomorrow Mr Treasury .

[talk2dubya] 19/4/2020 07:42

Would we not be eligible for some sort of a grant instead of a loan ? Interesting tweet flagged on LSE:



Get your google translate out!

[imjustdandy] 19/4/2020 07:20

Watch this space tomorrow Nobby when this is announced. We fit both categories IMO

[nobbygnome] 19/4/2020 07:14

>> imjustdandy

I hope you are correct but don't know how you are so certain.