The next focusIR Investor Webinar takes places on 14th May with guest speakers from Blue Whale Growth Fund, Taseko Mines, Kavango Resources and CQS Natural Resources fund. Please register here.
London South East prides itself on its community spirit, and in order to keep the chat section problem free, we ask all members to follow these simple rules. In these rules, we refer to ourselves as "we", "us", "our". The user of the website is referred to as "you" and "your".
By posting on our share chat boards you are agreeing to the following:
The IP address of all posts is recorded to aid in enforcing these conditions. As a user you agree to any information you have entered being stored in a database. You agree that we have the right to remove, edit, move or close any topic or board at any time should we see fit. You agree that we have the right to remove any post without notice. You agree that we have the right to suspend your account without notice.
Please note some users may not behave properly and may post content that is misleading, untrue or offensive.
It is not possible for us to fully monitor all content all of the time but where we have actually received notice of any content that is potentially misleading, untrue, offensive, unlawful, infringes third party rights or is potentially in breach of these terms and conditions, then we will review such content, decide whether to remove it from this website and act accordingly.
Premium Members are members that have a premium subscription with London South East. You can subscribe here.
London South East does not endorse such members, and posts should not be construed as advice and represent the opinions of the authors, not those of London South East Ltd, or its affiliates.
Oh, looks like the MHRA and EU contradict each other (surprise!). If that's the case and the HRA website takes precedence then apologies Nolupus - I stand corrected!
Nolupus, I would be inclined to go with what is on the approval over what is said in an interview. If an approval were to have a discrepancy then it could undermine an entire trial.
Is the amount of inhalation not controlled by the nebuliser? From the i-neb website;
https://www.usa.philips.com/healthcare/product/HC85167/i-neb-battery-powered-drug-delivery-system
AAD delivers the right amount of medication, regardless of size or breathing patterns. It can also be adjusted per condition (if approved to do so).
Bella - yeah. I'm not bothered. Wonder what'll be the next thing someone will think up to try to get people to worry about ;)
ChrisTOffer,
I think we should listen to Richard's interviews again and be logical :-)
RIchard has always stated that the treatment is the same for COPD as with Covid
On clinical trials website we see a discrepancy which we cannot explain ...
We know that both trials are set up for once a day treatment but as this is an inhaled treatment and not a tablet well we can only speculate about the discrepancy....
1) time of inhalation ?
Would it be stupid to say that one could inhale 6ml for 10 minutes instead of 12ml for 5 minutes ??
Oh I also forgot to mention cost considerations...if it does what is says on the tin with 1/2 the expensive bit then perhaps this is why as they will need to be able to sell it. Didn't AZ withdraw last time due cost or did I imagine that.
Ghia - Safe to say I disagree.
Hi Jakman, i do think you're onto something there as, "data from the 109 COPD patients with confirmed viral infection generates useful safety, biomarker and potentially efficacy data to support ongoing trials of SNG001 in COVID-19 patients."
In my mind the entire dataset is improved because they have 2 different dosing levels. It may also explain why it's taking longer than usual to collate and make it all presentable.
Rich... Richard has said on several occasions that it is, a formulation which is backed up by the patent. Perhaps they're using a slightly different formulation which helps make the Interferon perform just as well at a lower dose or perhaps the nebulizer creates a finer mist. Is this also why they wanted to check against COPD results to confirm it is performing as well, the same or even better.
Whatever the outcome, we need to stop this virus in its tracks and prevent it from attacking other organs including the brain... Some nasty long term side effects coming to light now.
Keep wearing your masks everyone.
Nolupus - interesting that even with the knowledge that Covid suppresses interferon production, they still reduced the dosing level for SG016 when they could well have gotten approval for the full dosage approved in SG015.
I mentioned earlier about the positive feedback loop that I read about. Just found it again;
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7188648/
"Notably, IFN-ß production leads to a positive feedback loop that further stimulates the expression of many of the IFN-a genes".
Rich - it’s not scaremongering It’s a legitimate discussion. After all the purpose of the trial is to prove safety and efficacy.
I think we are fairly confident the safety is good did they drop the dosage for Hospital on safety grounds to protect against cykotine storm or because they thought less was required for efficacy only SNG will know the rational behind the decision.
The trial Result will back them up one way or the other.
I agree with Chris It’s more reassuring that they have tweaked dosing rather than just duplicated COPd.
Simmo222,
I have never said that Synairgen have got it wrong or are desperate ...
I have however asked the question if the COvid patient at baseline is the same as the COPD patient at baseline ...
Timing of treatment is essentiel to the dosing imo ....
Like the patient with the headache if you give him the paracetamol tablet early enough it just might not turn into a migraine....
Great.........back to science......
Running out of scaremongering options? ;)
Maybe another reason for the interim readout of COPD results to produce a comparison of different doses with other types of viral infection into the lung?
Spot on as always Ghia!
Thanks for clarifying Rich! I find it really interesting (and reassuring) that they've adjusted the levels between the 2 trials. I guess if its been proven safe for COPD at 12mIU then a reduction wouldn't have been as hard to make for the covid trial.
Simmo222
Basically speaking , would you treat someone with a headache with a 500mg paracetamol tablet ?
Yes i would
Would I treat someone with a migraine with the same tablet ?
Well I would if I had nothing else to offer but I don't believe it would be very effective
Now it could be said that if you treated someone early on with a headache then it might not blow into a full scale migraine :-)
Anyway we will just have to rely on the experts as they never get it wrong :-)
I can only really think of two reasons for reducing the dose for COVID. Safety or efficacy.
I'd be quite surprised if they thought they needed to reduce the dose for safety reasons, bearing in mind all the other IFN-B studies (injecting more to the whole body), and all the existing SNG trial data using the higher inhaled dose safely in patients. So you would think it's surely more likely that they think they can achieve the same efficacy with a lower dose and that the amount of IFN-B entering the lungs has been more than sufficient.
Ok this board can't cope with brackets on the end. It was for SG015 and SG016:
https://www.clinicaltrialsregister.eu/ctr-search/trial/2017-003679-75/GB
https://www.clinicaltrialsregister.eu/ctr-search/trial/2020-001023-14/GB
COPD 12 million IU. COVID 6 million IU.
Chris - Agreed it was interesting to see the comparative dosing levels, regardless of type of IFN. Since everything else has been a much higher dose via SC or IV.
No one is questioning if SNG have got it right because obviously they have the experience. Equally it’s valid to suggest that the dosage may not be optimised for COVID since it is a carry over from COPD. This would have been a call that SNG made in order to progress quickly I trust they made the right call.
Hi Rich, am I missing something cause the Sg006 trial there shows 6mIU as well? I think SNG001 has always been 6mIU even dating back to the AZN sponsored trials in asthma.
I think my train of thought the other day when enquiring about dosing levels was to compare similarities/differences with the wuhan study to see if they were significant. The dosing levels were not massively different (6mIU compared to 10mIU per day) however it appears that the biggest difference is the type of interferon itself. That makes it harder to compare the studies, or use one as a projection for the other.
There was a question mark over the dosing level as the trial application for covid would have needed to be read across from COPD as much as possible to save time. I am confident in SNG that they wouldnt have gotten this far into 2 covid trials if they thought the levels weren't correct.
The most promising thing I did read was that beta is supposedly more effective than alpha. I even read somewhere that beta promotes interferon alpha production. Is that correct Nolupus?
I think the experts knowing best is a perfectly sensible response, rather than implying it's probably not going to be enough ;)
You say they can't change the dosage....well the link Dave posted suggests otherwise and suggests they HAVE changed the dosage (and reduced it).
The link for the COPD trial (https://www.clinicaltrialsregister.eu/ctr-search/trial/2017-003679-75/GB) shows 12 million IU.
The link for the COVID trial (https://www.clinicaltrialsregister.eu/ctr-search/trial/2020-001023-14/GB) shows 6 million IU.
That would suggest to me that they don't think they need as high dosage to achieve efficacy. Not that they haven't got enough.
Rich,
One does'nt need to know the exact dosage level in Sng001 to extrapolate
The simple fact is that the dosage level is the same for COPD patients and Covid patients
As many scientific papers have pointed out, covid 19 hampers the immune system response by blocking inf stimulation...
Just saying that Synairgen should know more than anyone is of course a way out of answering the question because as we know they had'nt any other choice but to go with the dosage level they had already tested with ( for safety and regulatory reasons because changing the dosing levels would have delayed the whole process )
If they had the choice , would they have gone with the same dosage levels ??
We should be able to ask ourselves questions like this without being brushed off with ´ the professionals know best ´ imv
Do we actually know the dosage levels in either?
One would expect that Synairgen, having been studying it for well over 10 years, are pretty well placed to get the dosing right...
ChrisTOffer ,
Comparing dosage levels of interferon beta and alpha is a waste of time and has no scientific basis ....
We may compare the dosing levels required for IV , SC or inhaled with interferon beta 1a if you wish or like myself ask oneself if the dosing levels should be the same for SNG001 in COPD patients as with Covid patients ?
Tougher questions which only the results may or may not answer