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Synairgen is now close to completing a Phase II study in COPD patients with confirmed respiratory viral infections and pre-existing significant impairment of lung function. With 109 out of a target 120 participants already dosed, this trial has been paused to minimise the chance of vulnerable patients being exposed to further infection risk and to minimise distraction for respiratory staff in the UK hospitals and GP sites conducting the trial, who will be at the forefront in dealing with patients suffering from COVID-19. The Company is currently exploring ways to adapt the trial to enable patients in the pre-treatment pool to be dosed if they become infected with SARS-CoV-2.
Early data from this double-blind, placebo-controlled trial have demonstrated that the antiviral responses in the lung (assessed using sputum biomarkers) are similar to those observed in the asthma trial, where we saw clinical benefit in lung function.
Use of proceeds
COVID-19 clinical trial activity GBP7m
Manufacture of SNG001 drug product and other supply GBP4m
chain considerations
Strengthened balance sheet for potential partnering GBP3m
discussions with regards to the COVID-19, future
pandemic preparedness, and the COPD opportunity,
working capital and fees
3. Current Trading and Future Prospects
Synairgen has recruited 109 of the 120 patients required for its IFN-beta trial in COPD, with data expected in Summer 2020. The opportunity now afforded to the Company with regards to COVID-19 is significant and the trial of SNG001 is expected to commence imminently. As at 31 December 2019, the Company had cash of approximately GBP2.45m (unaudited).
Looking to close out the Asthma Placebo trial by adapting the conditions for remaining 11 patients. Results Summer 2020 regardless of Covid activity.
This trial is also double blinded and placebo method. Yet note the paragraph reading Early Data, yet to be unblinded but they used Sputum Biomarkers to assess activity in the lung. Could this be the same way they have assessed Early Data from the current trial and hence pushed on to the extension, I think it could be, that’s why they are positive it works.
Look at the next bit use of proceeds, 4mill already assigned to manufacture the drug, I wonder how much of the 7 mill for the current trial is drug cost and how much is everything else? How much would 4 mill get? Then 3mill on top of current cash balance of 2.45 mill for future partnering discussions? Rumours of RM having meetings with Evercore I wonder what they do?? Or why he would need that meeting? I think there is so much to come here and believe a lot is going on in the background. They know they can’t go it alone so who are they going to sign up with? Deals for Covid and COPD IMO. The results from the previous COPD studies look perfect for Covid as the best results were shown with the people who would suffer most hence why they are being precise with recruitment.This has a high chance of being successfu
We know Manchester too their first a couple of weeks ago and Nottingham had its 3rd last week, Leicester still open to recruitment as well, Soton must have done loads starting in March and being based local. I think the timings they have put on are fine they should recruit and have finished by mid to end of May, if they did roughly 75 in 6 weeks another 25 in the next 3-4 weeks very achievable. Then data analysis and results June so flexibility to meet their deadlines did they ever give a date at the start or did they say roughly 8 weeks to complete?
E-mailed Jody to ask some questions last week, was passed out as you can imagine. I didn’t want to take up time that should be spent on the trial. The trial was listed to take 400 patients if required in or out of hospital so home trial is under same scope.
Good spot Miggy so recruitment could be a tiny bit closer, expect news next week outlining the home trial details and news of our seller and buyer!! Who took Griffiths shares??? And Lansdowne placing shares? And the 3.5 over last two days??? Someone has!! And expect another TR1 for Lansdowne shortly.
Interesting as they advised they completed recruitment in a week on the 22nd April so less than 10 needed at the other 9 sites! I wonder if they opened back up?
Wouldn’t surprise me if the drop is money leaving for AVCT and GDR as they both landed news this morning. These shares have an underbelly of traders at the moment jumping from one to the next.
I will be holding, not expecting FDA approval until anything up to end of June so possible it could be 8 weeks yet. However I echo the thoughts that investing some of this is a good move and would not be done at this stage if there was a high risk of not getting FDA approval. Looks like they are pushing full on to get these areas into commercialisation as quickly as possible which can only be a good thing with a small short term pain.
Miggy in his interview he mentioned providing doses on a global scale, I guess a 16 strong team won’t be able to deliver on that so support will be required to move to the next stage. Personally I hope we get taken over simply because I have no idea what I want to see at!!that would make the choice for me! Looks like we will get further news on the home trial from today’s RNS so news before the trial. Would they announce anything on a partnership/manufacturing deal before the trials are finished? I would be surprised if they did. What about this interest from other areas? Nothing yet. If successful you could imagine the news flow being huge on so many fronts. I think they will tell us when the home trial starts with details so hopefully another update next week. Can see that trial generating results for June as well should be quicker recruitment. Looks shrewd to have lined up the money for the production and drug production, but painful for us at the moment, I am sure we have suffered placing selling Maybe more than just Lansdowne look at the chart!! It will breakout on demand the last two weeks has clearly had behind the scenes activity hence the resistance.
RNS - great update 75% there results in June!! Novel study at home!
Successfully taking - not treated successfully slightly different. Still positive the medicine can be taken outside of hospital though.
It was 2 weeks ago with the AGM result where we had the brief one liner on the study being fast tracked and further updates to follow. Since then the trail has had two amendments, the focus as it should be is getting the trail right. I also expect there are discussions and interest in the background that is taking up plenty of time for the team. End of this week start of next week seems a logical time for an update of sorts on progress and changes, positive spin on home based trial would be massive for the company. The news is all about care homes what better time to say we are now trialing our treatment in the home which opens up massive potential to support those most vulnerable to the disease before it takes them into hospital. Not too worried about the SP I see the graph pattern and daily pattern of trading as Lansdowne and placing shares being sold into the rises. Let’s not forget Griffiths sold 16 mill, Lansdowne have sold 4 mil placing shares and we don’t know how many others have sold placing shares, where have they gone? No TR1 advising of new holdings so assume into PIs hands which is why the SP is where it is. Once the feeding has stopped buying pressure will take this up to where it showed it could get to.
ShareSting if they put out an RNS then the right people will find out, if they keep it to the HRA website then only those with an interest will be in the know. I can’t see why it wouldn’t be viewed as a positive by the market but there are a couple of areas of risk as Jack pointed out. It might not be in reaction to actual data but more from a practical point of view the hospital trial is not ideal for how they want to administer it or that recruitment numbers are not where they want them no update yet on this. The recent money raised from the placing must have factored this trial in and Richard has been bullish about global supply so that tells us something. Recruiting 120 people from GP surgeries can’t be a huge ask surely? And no competition for patients from other trials by taking this route. The addition of another Professor who if you look at his background is very attuned to this type of activity is another positive. Dates and length of trial could be pushed back as they need 14 days for a patient to complete which even if they recruited everyone next week is tight. Looking at June for results IMO but all this needs to be in an RNS so people are aware, I still think we get one today or tomorrow being month end/ start of new month with a progress update.
Simply has to be an RNS tomorrow morning, maybe approvals came late today after hours. Interesting to see how it will be positioned.
Jack/Trek love the debate one simple question why was this in the scope of the trial from the start if they never intended to do home trials and was a reaction to poor hospital data?
ShareSting the 50 consultants are they supplied by Transcrip? I assume they must be? Let’s not forget Transcrip are no amateurs look at their non executive board lots of links to Roche!
Jack it’s more down to getting the best possible result and looks like they identified some issues to iron out. The results you mention are diagnosis of Covid not impact of SNG001 on the patient. Don’t discount your points as balanced views required. I do however believe this was always in the study scope (I posted the link here last week) and IMO the fast track we had was this element of the trial. I guess we won’t know for another month who is right. It won’t take long to get 120 patients in home settings so don’t see a reason for delay.
Love the different opinions. I think it could be more middle ground and they found some difficulties on practicalities and therefore knowing the COPD experience are trying to address it quickly. Remember it is not Synairgen running the trial there is another company running it. Why wouldn’t they go into home trials?? Care homes, prevent hospital trip free up NHS beds. Sounds like the ideal area to target and opens mass market if successful for home use. As has been pointed out blinded trial results not known so how can we say it’s not going well? More likely this is the result of the fast paced approval IMO. Richard said updates to follow probably had to get everything in place.
This will also speed up recruitment can’t be difficult to recruit 120 across the country in the next 2 weeks.
There must be an RNS this week, substantial adjustment to the trial, expecting something tomorrow you can’t leave this to be found out via websites.
I wonder if being the 30th April tomorrow we will get an update, end of month, 6 weeks into trials and seems a logical time to provide a rounded report in progress and timescales for trial results.