The latest Investing Matters Podcast episode featuring Jeremy Skillington, CEO of Poolbeg Pharma has just been released. Listen here.
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Agree with Ghia to manage expectations for results write-up. RM said Q2, so let’s not expect anything until at least April, possibly a bit later.
The stakes are very high now (even higher than it was P2). So the last thing anyone wants is a rushed publication that someone important can poke holes in. Prefer to get it 100% and checked again and again and again before publishing. It’ll benefit us all as LTH.
I think my parents said they may get a 60 day follow up. I expect they are trying to add to the long covid data. Not necessarily protocol or end point data but good to have another 120 patients for the long covid factor too. Just builds the portfolio that bit more.
CW25 - only phase III and ACTIV-2 have follow ups post day 28 as per the protocols. Phase II (SG016) protocol states day 28 as the last day.
ApricotDanish - wish you well with your recovery!!
Thanks AD. Good luck with your recovery.
matterhorn - not that I know of but will check. I did read somewhere there was a 60 day long covid check up but think that was on the p3 protocol?
Interesting. Hope symptoms have abated for you now AD. Were you assessed as per the protocol or was it just a general check up on how you were felling?
Sterland55 - it's rather interesting that you received a call from a nurse this morning which is give or take day 50 for you. The SG016HOME protocol only states follow ups up to day 28, unless Synairgen is doing informal (long covid) check ups on patients. The fact that you weren't fully recovered at day 28 could be the reason for this follow up. There was no communication from the company stating any amendments to the protocol and I'm sure they would've communicated any such amendments. Intriguing.
I wonder whether CW25's parents who were on the trial also received a call long after day 28.
I've posted on tis before but I was enrolled exactly 7 days before the final patient. I was told initially that once everyone had completed, it would be 8 weeks before everything 'unblinded'. I'm not quite sure what that means, but on any view, that's Q2 - as per the RNS. In fact I was rung this morning by the nurse practitioner who supervised me and she was checking up on my status as I did not class myself as fully recovered when we last signed off in the first week of Feb. I confirmed I was 100% now and she had a list of patients to get through. So they're clearly still processing and finalising patient records and presumably that's all before the actual results of placebo/treatment are ascertained. So again, April onwards sounds totally realistic, but not perhaps before.
Seeing as the earliest they could possibly be is mid - late March it would have left the company a very short window to release them if they communicated Q1. As Ghia said Q2 gives them breathing space but I'd imagine they could land anytime from two weeks today...
Tommy - I think it's prudent to manage our own expectations I've seen it time and time again that we get ahead of ourselves and then the boar descends into misery when self imposed deadlines slip.
SNG has said Q2 so lets plan to that. If it comes sooner brilliant but lets not plan for that.
My strong expectation is preliminary results statement via RNS next Monday.
Peer review takes time but based on the need for solutions, I would expect some prelims within the next 6-8 weeks...
Candid...the RNS states Q2....
Southampton, UK - 20 January 2021: Synairgen plc (LSE: SNG), the respiratory drug discovery and development company, is pleased to announce that recruitment of 120 COVID-19 patients into its Phase II trial evaluating inhaled formulation of interferon-beta-1a (SNG001) conducted in the home setting has now been completed. Results from the trial are expected in Q2 2021.
So April-June. April means we can load up our new ISA allowances....there is potential for the Activ2 trial to move to P3 in March...plus EUA etc. So plenty news to come over the next few months.
I would also like an update on production capabilities. Surely this must be well in excess of the 100,000 RM was talking about last year (given 2 interferon suppliers not just 1).
It looks like the Brazilian strain si now in the UK, probably rest of Europe....unfortunately, this is not good as I believe it has stronger resistance to the vaccine. I dearly hope for all our sakes that this is not the case, as we need to get on with our lives.
All the best Synners...
Any thoughts as to when the results of this trial will be announced.
I think it could be soon.
Patient numbers fully enrolled for this trial was announced on 20th Jan:
“recruitment of 120 COVID-19 patients into its Phase II trial evaluating inhaled formulation of interferon-beta-1a (SNG001) conducted in the home setting has now been completed. Results from the trial are expected in Q2 2021”
Going by the previous data readout (magic Monday) on 20th July 2020, the announced full enrolment of patients was around 7 weeks prior to that.
The data readout might come sooner than expected as they already have the protocol in place for data analysis from last year.
They could of course hold off until the data from Active 2 trial is also available and announce both together. Thoughts?