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in answer to a question on Activ-2 trial for inhaled interferon they said they expect P2 trial to complete in "next few weeks"
SNG interferon question and answer is from 35 minutes in
Kansas have enrolled over 40 patients themselves on to Activ - 2. Roughly 6 of those have been enrolled into the inhaled interferon arm of the trial. Available for mild out-patient cases. "Exciting to find out the results as its an at home treatment". Completing P2 next few weeks (110 patients across US sites). Then results will be reviewed by FDA and then they will make a decision to go to P3 which will be 1000 patients.
Great news and I’m sure all those people who’ve been complaining about a lack of activ2 mention from RM will be along shortly to appreciate this good news.
But I won’t hold my breath
Thanks Alphageddon, really interesting. I was drafting an email to Synairgen to point out that there are a few of the inclusion criteria for the other ACTIV2 trial drugs that make sure the patients enrolled are higher risk. I had been hoping it might have been possible to only recruit significantly breathless patients for SNG001 in ACTIV2. I can see it is too late to change pre-P3 ACTIV. The good news is that if any signal is visible at all, and the FDA/USGov have access to our HT too, they may commit to a full P3 home ACTIV in only those that are markedly or severely breathless on the OSCI scale at presentation.
Anyway we will have 110 more patients that will add to our safety data, and may add to a meta-analysis no the subgroup that the HT science has indicated we should focus on - marked or severe breathlessness.
I am somewhat concerned that ACTIV2 seems to have disappeared from the Synairgen site apart from the news of inclusion and first dose. Hopefully that is not a bad sign. Great to hear Dr Castro thinks it will be weeks until last dosed SNG patient in ACTIV2!!
ACTIV2 inclusion RNS 25th Jan
ACTIV2 first patient dosed 15th Feb
Dr Castro thinks 110 dosed "in the next few weeks"
If we assume by 10th June, that would mean 4 months to get 110 done. And he says circa 1000 for P3 ACTIV, though that number will be decided later from a power calculation after the ACTIV2 readout. The rate of recruitment is not fast but would be much quicker for ACTIV3, if it happens, as sites will be fully set up and used to using it. Indeed the USGov may add lots of sites to those drugs that progress from 2 ->3 as they have cleared the first hurdle and will be seen as more worthy of focussing on? All IMHO
sorry 2->3
Dosed 1 person a day! Country ravaged by disease and 300 million people?
Hardly inspiring
But as we all say
If it works it doesn’t matter
Despite your negativity we keep rolling forward toward approval.
It must really pain you that your deramping is so ineffective
I’m in
So I ain’t deramping
Topped up and borrowed to do so at 101
So I’m am v v much all in
I’m just so confused about constant drop
But delay is time. Time is money. If it works on breathless COVID non COVID it has huge future
If you build it they will come
That’s how I feel
Motley Fool aren't much better. Damned fence sitters imop.
Boyg you are a liar and a de-ramper. **** off
Er..... oak leaf
I don’t lie
I don’t deramp
I do, however, enjoy a good roll around
The great news is that in a few weeks more data will be added to the growing evidence of our drugs safety and efficacy. The chances are that the activ2 trial will find at least the same results we did in our home trial and the possibility find the results we missed in the placebo group. Either way I think it’s highly unlikely we’d have been kept on the trial this long if results were unfavourable. I’m feeling pretty confident that phase 3 is about to happen and although we may have some reservations about home trials and patient recruitment, a phase 3 admission to a USA led government trial is huge for Synairgens profile with the possibility of EUA
The other great news is that long after Covid-19 is over, and that won’t be for many years yet. Our drug will still be treating millions of patients with respiratory viral infections and saving billions in associated hospital costs.
The future for Synairgen is very bright
1. Many contributors have expressed concern about the lack of comment about ACTIV-2 progress during Richard Marsden's recent interview with Proactive Investors London. The Full Year Results statement, which complements the interview includes the latter, as does the accompanying Chairman's statement. ( both quoted below)
Moreover, as the financing and administration of the ACTIV-2 trial are not within Synairgen's remit, would it therefore be inappropriate for Richard Marsden to provide any update as regards its progress?
From the highlights:
" SNG001 included in US NIH government-funded ACTIV-2 Phase II/III trial in COVID-19 outpatients in January 2021 and commenced patient dosing in February 2021. Phase II evaluation will see the recruitment of up to 220 participants."
Chairman's statement;
"The inclusion of SNG001 in the US government-funded ACTIV-2 trial is a further indication of international interest in our inhaled interferon beta treatment."
2. In recent days, two contributors to this board referred to Synairgen's "failed COPD trials". Comments in the full year results statement beg to differ.
From the highlights:
"Positive data from interim analysis of SNG001 trial in COPD patients supporting future progression of SNG001 for exacerbating COPD patients".
" Phase I and II trial data have shown that SNG001 activates lung antiviral defences as measured in sputum cells, and that SNG001 has been well tolerated in approximately 280 asthma/COPD/COVID-19 patients to-date." (unequivocal evidence of the drug's safety)
I believe that these trials were suspended, with the company's priority shifting to Covid-19 trials. There is nothing here or elsewhere to indicate any "failure" during the interim progress prior to the trial's suspension.
The Full Year's results statement is detailed and comprehensive. Everything is reasonably straightforward, in sufficient detail, and above board. I look forward to the forthcoming results, particularly those from Synairgen's Phase III trials.
Regards and good wishes to all genuine Synairgen investors.
TLWILLIAMS
100% agree with what you're saying. Activ-2/3 participants would almost certainly have been gagged on enrolment.
It is a 100% us government funded trial and they will control all data and media releases, that would be a totally normal and expected approach, also giving them first refusal on successful treatments imho.
@35 mins.
Doc why are you always using such negative language these days?
"If they chucked us off"
"If that happened sp would take a hit"
What a load of rubbish!
If we we're upgraded to activ-3, if a body of evidence suggested it would be hugely beneficial to the affectivenes of our drug, then the share price would rocked up.. no question at all!
Have you sold recently and now hoping for another dip to enter before news? Possibly, hence all the negatively, suggestive posting ...
Doc - why on earth would you want SNG001 to be removed from ACTIV-2 which would kill off a potentially huge market for Synairgen especially since it may potentially be the or one of the best therapeutics to prevent people from being hospitalised in the first place. SNG001 will never be added to ACTIV-3 as there is no need for such a move as we do have a phase III trial running at the moment.
Page 14 of the protocol has the following to say about who gets what agent. The decision to give SNG001 to lower risk patients is quite telling.
'For infused agents, enrollment will be restricted to participants at higher risk of progression to severe COVID-19. Non-infused agents will be open to participants at both “higher” and “lower” risk of progression to severe COVID-19.'
The doctor's words in the video are being misinterpreted.
Doc, you constantly talk nonsense designed (in many ways) to confuse. SP is where it is and your job is done. Move on ffs
Great news from Kansas. Doc see 35 -38 mins. A very good question but Kansas was only able to give recruitment figures for that particular hospital. Slow take-up. 40 total for all 5? Activ-2 treatments and about half a dozen for SNG001. We don't know how many centres have SNG so it is difficult to extrapolate total take-up.
The protocol stated that I/V would be generally reserved for more serious patients and I suppose the corollary is that there will be more of the less serious cases for interferon. I am not sure this was the intention but the Kansas guy definitely said that the less serious cases were being used in the interferon trial. About six so far out of 40 in Kansas and he thought a few weeks to fill the 110 people for SNG and then to be assessed for suitability for P3 by external bodies inc FDA. Hopefully more hospitals will be recruited if and when we get into P3 (1000) patients.
It definitely seems that our treatment has been slower to fill than the Brii product. Also if only less serious patients are being treated with SNG it may well be that we will only get safety data and not much to help efficacy figures. This should not prevent progression to P3. I am sure Synairgen will ensure that the data from the home trial will be given to the Activ-2 trial administrators and there is certainly a possibility that the protocol for P3 will be changed in order to obtain statistically relevant figures.
Best to all investors
Spinnaker
Doc, I don't pretend to know much about science, investing or the commercial world but I can spot a bad person a mile away. It always came easy to me that. Even got told off on Redditt for calling one out.
Doc, re your 19.31 post.
What would be even better is if they put us into P3 in Activ-3 in parallel with upgrading to P3 in Activ-2.
That would definitely be positive for the SP.
Spinnaker
Matterhorn and Matt
I don't think we are misinterpreting the doctors words but he may be misinterpreting the protocol as I implied below. The protocol did not have the intent to limit SNG to less serious patients but that may happen by means of misinterpretation of the protocol and/or the natural situation that seriously ill patients are sent to hospital for I/V treatment leaving only the not very ill for the Camostat pills and SNG.
Spin