The most promising treatment is not in the top 5. Is that because another government(s) have a (substantial) preferential order and the EU does not want to invest when it has to play second fiddle?
Just a wild supposition.
And so Germany has eventually decided to join SG018 with 22 patients to be recruited.
Date of Competent Authority Decision = 29 Jun 2021.
https://www.clinicaltrialsregister.eu/ctr-search/trial/2020-004743-83/DE
Alphageddon - I thought so too, but I can't find a news release from the NIH announcing progression to phase III for BRII-196 and BRII-?198. It seems Brii Biosciences was the first to announce the news by issuing a RNS, unless someone can point me to it. We may or may not follow the same path.
Thx Helen3. So of the four agents starting in Feb 2021 SNG001 is the only one standing. From that I deduce that the other three already had their day 28 analysis.
So either SNG001’s day 28 analysis has already been performed, was successful and they’re finalising the phase III protocol or the other way round. Something along those lines it seems. And, while we’re in this holding phase they’ve started phase III recruitment as per Dr Castro to expedite things. Brilliant.
*its protocol
I struggle to find that argument of mine flawed. Using Recovery and ACTIV-2 in the same sentence as a counter argument is flawed.
ACTIV-2’s protocol is of a higher standard and collects better data than SG016HOME’s protocol. So it’s to our advantage.
Recovery is not even a double blinded trial and it’s protocol is/was inferior to SG016 & SG018.
Additionally we needed an international trial to enhance our chances of approval from other health authorities and to enable Synairgen to gather data to appropriately price the product. Would that have been granted on a UK based trial like Recovery given it’s a novel treatment?
And, to what extend would inclusion in Recovery have limited the quantity and quality of data gathered to maximise future potential use of SNG001?
By the time of that tweet Synairgen have already received approval by the UK & EU to conduct SG018 and were in advance talks with the US. In fact the trial was supposed to start end of Nov.
Obviously they’re not going to include SNG001 in Recovery. Duplication of effort and waste of valuable resources. Not saying these are the reasons, however it could have played a role.
Agree hanoihank.
SG016 Hospital was based on 86 patients - per protocol analysis. No health authority will entertain approving a drug on such a small data set.
Synairgen received Urgent Public Health status from the UK, US & France enabling quicker trials. This in itself is invaluable.
SNG being part of Recovery would potentially have been disastrous for Synairgen. You want those who know the drug best to design the trial protocol and to control and conduct the trials, not someone else. Evidence of this was the IFN trial run by WHO. It didn’t end well and damaged IFN’s image.
What should have been done differently is to give greater patient access to SG018 instead of competing against Recovery. Or so it seemed.
Jez2 - they advertised for a Clinical Quality Manager back in Jan 2021. It seems as though the ‘4 day’ reference is misleading. Synairgen always list any new roles on their website and this one is not listed.
Great find Joshholdforgold.
How’d you find that as it doesn’t appear when searching Synairgen?
SNG001 treats the cause. Ampion treats the effect. Different stages of the disease, but with some overlap. Treatment with SNG001 should mostly eliminate the need for Ampion - I'd hope.
Their phase II trial focuses on a similar hospital patient group as SG018. COPD patients are excluded.
https://clinicaltrials.gov/ct2/show/NCT04868890?term=AP-019&draw=2&rank=1
Oak - nope. One thing I’ve learned is not to create expectations.
Exactly.
It will be interesting and rather entertaining to see how things unfold over the next few months.
Matml74 - thanks for the link setting out both sides of the arguments. Much appreciated.
I agree data is king and that is the way to go about it. The only reason why I was entertaining the possibility of a readout is because of the circumstances we're finding ourselves in and if results are only released beginning of Nov we'll potentially not be in a position to supply reasonable quantities of drug during the first few months of winter. Note, I would only expect a readout if the signal is exceptionally strong.
I had a look at SG018’s entry in the Spanish trial register and it seems the first patient was enrolled on 01 Jun 2021 even though the trial start date is listed as 27 Apr 2021.
If that’s correct it means that more than a third of the 610 trial participants are from countries where enrolment did not start before Jun which is five months after the first patient was enrolled. The ‘third’ is based on the maximum target set for these countries [Spain (87), Italy (41), India (88) & South America (?)], although it does not mean actual recruitment will reach those country specific targets.
I doubt Synairgen envisaged such a slow roll-out of the trial. In my view this strengthens the rationale for an interim analysis and readout. Richard did mention in one of the Proactive interviews that an interim analysis and readout makes sense when recruitment is slow.
As per my original post, not doing an interim readout will hurt sales as it’ll be too late to have shelves stocked ready for the winter.
We'll have to wait and see.
https://reec.aemps.es/reec/public/advancedsearch.html
Eudract: 2020-004743-83
Last week or over the weekend, can't remember, someone asked about the benefits of the Aerogen Ultra which is used in phase III vs the Philips iNeb used in SG016. Here's a good article, which most of you would've seen already, talking about the Synairgen / Aerogen collaboration.
A factor which may have counted against SNG001 last year was the hesitance in the medical community with regards to using nebulisers due to the risk of infectious aerosols. A risk which is mitigated by the Aerogen Ultra. It's a good thing Synairgen switched.
https://www.hospimedica.com/covid-19/articles/294785231/closed-circuit-nebulizer-technology-to-help-deliver-potential-covid-19-inhaled-therapies.html
Misspoke? No. Misinterpreted? Yes I’d say so as I suspect SNG001 has been given the go ahead to commence phase III recruitment while awaiting final day 28 analysis at which point a final decision will be made on progression.
No the trial is not filled, by no means.
My original post stated that the U.K. leg of the trial is stated to be ‘no longer recruiting’ as per the link provided earlier. However, as pointed out by Joey it could be that the status was automatically changed to ‘no longer recruiting’ due to an ‘end date’ which was listed from the outset.
So we don’t know. Again, this referred to the U.K. leg only.
s120896 - that is a possibility of course and so I’m not focused on the date. Even one of the current completion dates on the NIH protocol is wrong. BUT, what I do know is that the recruitment status have changed. I vividly remember it used to state ‘Recruiting’.
He knew exactly what he said. It's just been incorrectly interpreted by some I'd say.
Some news at least and that is that the UK leg of SG018 has concluded with a recruitment end date of 01 Jun 2021.
https://www.isrctn.com/ISRCTN85436698