Member Info for DPC1825

@Carsgeek, we will receive a 'last patient dosed' RNS for P2 ACTIV-2 trial, we will receive a 'last patient dosed' RNS for international Sprinter P3 trial (I do not believe we will receive an RNS for the UK element of sprinter in isolation – I could be wrong here though).

Synairgen have told us (Assumed Worse case):
UK HT results can be expected by the end of June (if not before) ‘Q2’, it is my personal belief this will be late April.
Acitv-2 P2 Results can be expected by the end of June (if not before) – ‘Q2’ish’
Acitv-2 P3 Onboarding (If successful) can be expected by the end of July (if not before), ‘Q2’ish’ + 28 days.
International Sprinter P3 results can be expected by end of September (if not before),

I think it is important to remember all trials are still operating well within the expected timelines and parameters set by the company – nothing is currently overdue.

RM statement from Jan: https://www.youtube.com/watch?v=nhFqeW6sIXg
Sprinter Trial: https://clinicaltrials.gov/ct2/show/NCT04732949
Speak to Kris at Consillium for independent verification if required.

Thank you for confirming Matterhorn. Agreed, I had noted that the current absence of the P3 protocol for non-infused agents could add additional lead time to the Activ-2 P3 trial integration.

Strong chance of success here, patience is all that is required.

I believe your timelines are incorrect.

First and foremost we will receive an ACTIV-2 'Last Patient Dosed' RNS

We know we will then wait 28 days from the 'Last Patient Dosed' for analysis.

Then if all looks goods we will progress to Activ-2 P3, so we are at the very least 1 month away from progression to P3 (if not more).

That's my understanding of the key milestones here, please correct me if I'm wrong.

From the Synairgen Website - My guess is that is has something to do with the last line (However I'm no expert) :

'Two Phase II trials (SG005 and INEXAS) in asthma, conducted by Synairgen and AstraZeneca respectively, suggest that SNG001 boosts antiviral responses in the lungs, has a beneficial effect on lung function and, in more difficult to treat patients, improves asthma control during cold infections. However, the unexpectedly low exacerbation rate (<10%) in the INEXAS trial population suggests that the economic viability of the drug in an asthma indication would be limited.'

Ref 1: https://www.synairgen.com/programmes/ifn-%CE%B2-sng001-in-copd/

@Prion25, that was my initial concern as well, especially given we know the french are also currently trialing nebulised interferon-beta.

Hopefully this is just some muscle flexing that will die down.

'The European Union is preparing to use emergency powers to grab 'Europe's fair share' of vaccines from Britain including export bans, the seizure of factories and overriding patents on the Oxford-Astrazeneca Jabs'
THE TIMES - 17th March 21 1:15pm

@Junior, depends on your definition of soon, I am hoping for a Home trial RNS between 14th April - 30th April = 2 months blinded data since last patient dosed + 2-4 weeks for analysis.

P2 Activ-2 is anyone's guess as I don't believe we have any information or indication on how quickly this trial is being filled, and therefore cant estimate the 'last patient dosed' RNS or the follow on 'post 28 day' analysis RNS.

I'm hoping for a P2 Activ-2 last patient dosed this month but I might be too optimistic and have no experience in this arena.

'It reads to me that they are not able to supply to everyone who wants it, rather than they cannot supply to everyone they want to.'

@Simmo222, that's a really interesting view that I had not considered. I don't necessarily agree with you but its certainly food for thought.

'I think the overly optimistic approach mixed with a tendency to take a swipe at the vaccines and other drug developers too will be off putting to new investors.'

Absolutely agree Harchris, and I cant be the only one that has found comments of this nature cringe & difficult to read.

Doc also very much appreciate the recent contributions - fair, reasonable and balanced.

In my opinion:

£6-£8 ps by the end of Summer 21
£10+ in Jan 2022

Assuming all goes our way.

@Scinv - personally I also value your input here and believe you do bring an element of balance to the board.

Well done Tiger (And Eva)! looking at the sp increases now - very goods calls (Credit where credit is due).

Speculative Guess: Activ - 2 trial start RNS (First patient dosed), tomorrow morning??

@JoeyDiamond, I very much appreciate the clarification, I had misunderstood the released statement - apologies.

@smokieUK,
I referenced the web link for transparency in case misunderstanding was incorrect, and as mentioned I would happily be corrected.

My understanding is that there were two primary endpoint's:

PEFR (P= less than 5 (0.041, so endpoint was met)
BCSS (P= assumedly was greater than 5 so the endpoint was not met?)

However, the results were promising but warrant further research.

@Blessed22, in the words on John Bercow 'ORDER....ORDER...'

Feel free to correct me if I'm wrong but I believe the COPD trial missed one of its 2 primary end points.

Synairgen Statement: 'Although there was no SIGNIFICANT DIFFERENCE in total BCSS in this group over
the treatment period, there was a trend for the breathlessness component of the score' (1)

Ref 1: https://www.synairgen.com/wp-content/uploads/2020/09/200908-SG015-Press-Release-Final.pdf

@Scinv, yes this is my biggest concern currently, I believe P3 results due at the end of this month.

Shows you how quickly big pharma can move.

'Having made this statement to the markets, I don't think they are obliged to report first dosing.'

This comment is 100% INCORRECT, and has been made several times on this board.

Response form Consilium yesterday regarding 1st doing:

'Thank you for your email.

As a listed company Synairgen would have to report via RNS announcement any material information relating to the company including progression of SNG001 as a treatment. This would also include first patient dosed in the SG018 Phase III trial.'

hope not.