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The text matters, because it provides a clear guidance to competitors as to exactly what has been patented and it will of course be used by the owner of a patent as and when they have to take legal steps against anyone breaching their patent.
Where in the influenza patent do you see it covers SNG001’s formulation specifically?
Scinv - first of all. Do not use capital letters when you talk to me. I’m not a toddler.
Secondly, I never said it’s law. I know how it works.
The text detailing the covid-19 patent is not publicly available so there’s no guarantee it’ll read the same as the influenza one. Although the chances are good I guess.
I read the current patent to be broader than just the specific INF beta formulation based on how it’s defined. The treatment method, illness and stage of illness forms part of the patent.
The use of Inhaled IFB beta would have been allowed to be used for covid-19 prior to the registration of Synairgen’s patent. Again we don’t know what this patent (i.e. Covid-19) protects.
Further the influenza patent ONLY covers Influenza so the use of inhaled IFN beta for any other virus would have been allowed.
Testing/trialing inhaled IFN beta does not breach a patent. Only once you want to commercialise it - that’s my understanding.
Here’s some text re the influenza patent …
[0008]
We have now found a new method of treating individuals, particularly hospitalized patients, with lower respiratory tract illness that has developed during or following an ILI.
Summary of the Invention
[0009]
Accordingly, the invention provides interferon-ß (IFN-ß) for use in the treatment of lower respiratory tract illness that has developed during or following an established influenza like illness (ILI), wherein said treatment is by aerosol delivery of said medicament to the lower respiratory tract; wherein ILI is defined as (a) a fever >37.8°C plus two of the following symptoms: headache, cough, sore throat and myalgia and (b) confirmed influenza; wherein established ILI means an illness in which the symptoms have been apparent for at least 48 hours; wherein the lower respiratory tract illness is caused by influenza; and wherein the IFN-ß is delivered to the lower respiratory tract by aerosol at least 48 hours after ILI symptoms become apparent.
Definition of IFN-ß.
[0015]
The term IFN-ß as used herein will be understood to refer to any form or analog of IFN-ß that retains the biological activity of native IFN-ß and preferably retains the activity of IFN-ß that is present in the lung and, in particular, the bronchial and/or alveolar epithelium. The IFN-ß may be identical to or comprise the sequence of human IFN-ß1a (SEQ ID NO: 2) or human IFN-ß1b (SEQ ID NO: 4). IFN-ß also refers to a variant polypeptide having an amino acid sequence which varies from that of SEQ ID NO: 2 or 4. Alternatively, IFN-ß may be chemically-modified. A variant of IFN-ß may be a naturally occurring variant, for example a variant which is expressed by a non-human species. Also, variants of IFN-ß include sequences which vary from SEQ ID NO: 2 or 4 but are not necessarily naturally occurring.
https://patents.google.com/?assignee=Synairgen&oq=Synairgen
You’ve got your trials mixed up. The clinical trials website you’ve got phase II. The EU link you have the original and now out of date phase III protocol.
We should get one within the next seven days whether that’s in the form of an RNS or updated SG018 trial protocol. We’ll have to wait and see. This is based on the timelines the company set out for phase III recruitment.
SNG001 is being trialled as a treatment for covid-19 and to determine whether it’ll prevent or lessen the effects of long covid. But, it’s not being trialled as a treatment for long covid per se.
Doc - yes they could’ve done more re home trial. I guess they treated it as an insurance policy (which is what they said) and instead focused on getting phase III hospital up and running not realising the value of the home trial.
Ads1982 - your biggest issues seems to be with the perceived delay in SG016 HOME results. There are mainly two reasons why we've not seen results yet.
1) The trial collects long covid data where participants are followed up at day 60 and 90. Day 90 for the last recruited patient was Monday 19 Apr. If you read the protocol you will notice the questions being asked at these intervals are open to bias should results have been released prior. To ensure the trial's integrity is protected results have not been released.
2) I'm sure you're aware long covid has become an increasingly important 'illness', if I may call it that, for which there is no preventative drug and/or treatment. As far as I know SG016 is the first trial to have covered long covid and if all goes well SNG001 migth be the first drug to show efficacy in preventing long covid.
Your disappointment is the result of a lack of knowledge, not because of the company's management.
Fruitsnveg - your comment is misleading in that you are quoting cumulative cases since the pandemic started. That's rather different to the current situation. And, Doc's comment refers to the current situation. Of course they have covid, but the rate of infection is not high. I would however expect the rate to increase as winter approaches.
https://graphics.reuters.com/world-coronavirus-tracker-and-maps/countries-and-territories/south-africa/
But, having said that winter is coming up. It'll be interesting to see how that goes.
Shpunken - South Africa is not being ravaged by the virus. They’ve had super low infection rates since beginning of Feb. Managed to get the spike in Jan under control with a some restrictions, not even a lockdown. Currently it stands at 14 per 100k whereas the UK is now at 25.
Estimated phase III (SPRINTER) final dosing is 04 May which is derived from the Primary Completion Date of 01 Jun.
Primary completion date - The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure.
John117 - try the below.
https://uk.linkedin.com/in/simonwholden
Invt - if everything falls in place perfectly as intended we’re probably looking at the 2nd half of Jul at the earliest. I’m hopeful we’ll get an indication within the next few weeks on progress which will give a clearer indication of when results are to be expected.
Schrow123 - thanks for stating your thought process. Makes perfect sense to me.
Agree with you Oak. It’s very possible both phase II home trials might just prove sufficient for EUA provided results are strong. I think RM knows already what is required for submitting an application. It would’ve been discussed I’m sure.
I just found this and it seems that you can commence a trial in India at a site once that site’s ethics committee (EC) has approved the trial. Refer to rule 25(i) page 156. It could be that the recruitment start date of 04 Jun is the date at which they expect all ECs to have provided approval, instead of the actual start date. Agree with you Schrow123 - their regulator have had a good look at our data and it'll make approval of drug easier should we conduct trials there which is why I like rule 25(xiv) of the link.
https://cdsco.gov.in/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=NDI2MQ==
Schrow123 - we’ve not had many EU countries going for long. Spain and Portugal seems like the only two that may have started recruitment in the 2nd half of Mar. Even though Belgium seemed to have started beginning Mar it turned out this week with the update of the EU trial register that their Ethics committee only issued an approval on 31 Mar.
What I found interesting re the UK was the addition of Nottingham NHS Trust at the end of Mar which is quite late given we’ve started on 10 Jan. Nottingham only admits about seven covid patients daily on average (at present) so have we added them because we’re having some trouble filling our UK cohort even though we had 15 sites as at 21 Feb or are we expanding UK recruitment beyond the set target.
Matml74 - that’s correct, but to meet the said date the last patient need to be recruited by 04 May.
Definition of primary completion date as per NIH trial register: ‘The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. ‘
Doc/Ghia - I share your concern around the perceived slow start of the phase III trial.
There are 10 days left for the last patient to be recruited if the trial is to meet its ESTIMATED primary completion date. I know it’s an estimated date, but how will it be perceived by the market if the trial is delayed? (Especially when you call it SPRINTER.) It sure would raise the risk profile to a certain extend if getting the product to market is delayed, provided it’s successful.
As of late I question the rationale for conducting a trial in India as the risk is just too high. I’m saying this for two reasons:
1) Trial start date is 04 Jun which is after phase III is supposed to have finished collecting primary endpoint data. Recruiting 88 patients across 10 sites will prob take a month to be safe which means the trial is delayed by two months.
2) Point raised by Ghia - the situation is so bad the hospitals will not have the time to conduct quality trials and there’s no guarantee things will have improved by 04 Jun. This is what happened when they aimed to do trials in Italy in Jan/Feb 2020.
Obviously we don’t know what’s going on behind the scenes and we may even complete the trial as per the estimated dates. Should that not be the case will the company decide to do an interim analysis? I hope so.
Interesting. Quite late.