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There are other potential uses...

https://www.sciencedirect.com/science/article/abs/pii/S0306987722002365

It's a very good point Doc

Also to consider is the potential for a grant or other non-dilutive funding

https://medicalcountermeasures.gov/newsroom/2023/ards_baa/

What is interesting is if they can deliver a successful P2 the successful safety data of a P3 is already established.

Https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10272952/

Inhalation treatment with IFN-β-1b and LPV/RTV successfully cured patients who had a worsening respiratory status after antibiotic and hydroxychloroquine treatment failed to reverse COVID-19 progression [89]. In a retrospective cohort study of 466 patients, treatment with aerosolized IFN-α2b within 5 days since hospital admission lowered in-hospital mortality risk [90]. Another double-blind RCT showed that nebulized IFN-β1b had greater prospects of conferring rapid improvement and recovery [91]. In a systematic review and meta-analysis, several RCTs consistently reported that IFN-β treatment can lower intensive care unit admission risk by 42% and increase the discharge rate by 3.05-fold in patients with COVID-19, thus supporting its use as a safe therapy for COVID-19 [92], [93]

A heads up that the French inhaled INFb trial has been updated on clinical trials dot com, with the trial completed on 16 June.

https://classic.clinicaltrials.gov/ct2/history/NCT04469491?A=9&B=10&C=merged#StudyPageTop

Looks to have stopped at the halfway mark.

DD

With the auto-abs, this was probably discussed the most and I got the impression that it would be on hospital admission and multi-viral, with the other subsets it's difficult to say as finer detail wasn't discussed and with for example ventilated patients one would assume they have been in hospital for a while.

The question of it would be one trial after the other or concurrently was asked and answered that each trial would run at its own pace depending on the cohort, so start and end times would vary but the start of one would be dependent on the other finishing etc.

Sorry missed one out

Ventilated patients

So it would appear we are looking at up to 5 separate but associated trials.

An interesting point raised today was that while the 'clock is ticking' on various SNG001 patents, the Exclusivity window on approved biologics in the US is 12 years and between 8-10 years in other jurisdictions.

In terms of the cohorts to be stratified (and assumingly the different trials to be run) I have the below in my notes:

Auto-abs to inf (with input from the Casanova group)

Auto-immune

Long term viral persistence

Patients with "high" viral load

There was also mention of "the elderly" tho I am not sure if that was a larger subgroup they would target in further trials

The impression was that these trials would be multi-viral and that some by the nature of the condition they are treating would be open label

A shareholder I think summed it up well towards the end. At last year's AGM the theme was very much "hope"

Hope to get on a platform trial, hope to pull concrete and encouraging data from sprinter, hope for long covid results etc etc

This year the theme was plans. Highly targeted company run trials that will produce the data required by regulators and partners.

The overall takeaway I have on first reflection is the data they generated over the pandemic, together with advancements in testing (ie auto-antibodies) will allow highly targeted P2s (some potentially open label). The data generated from these studies will then create the inflection point for share value and the interest from potential partners. There will be multiple studies, all targeting a different cohort of stratified patient (IE, one study for auto-abs, another for ventilated patients, another for auto-immune etc)

This in the context that non-dilutive funding and platform opportunities are still being persued.

Happy to be corrected, but I believe the resolution re NED pay is retroactive - IE they have already gone over the limit.

Yup.

Another installment of the companies partnership with Scientific American, Rick Bright, de la Cruz etc

https://www.scientificamerican.com/custom-media/how-immune-boosting-medicine-could-save-lives-in-a-pandemic/

Https://cms.mhra.gov.uk/mhra/api-reg

https://cms.mhra.gov.uk/mhra/api-reg/uk-api-33401

Anyone know what this means? Dated 13 May 23

Https://www.moneycontroller.co.uk/finance-news/synairgen-plc/7th-isirv-avg-conference-2023-1355219

I guess a big question with this one is if Universal is looking at the same biomarkers

Thanks Titania

Just as this study has come out of France, a little reminder that a study of inhaled INFb is ongoing in Amines

https://clinicaltrials.gov/ct2/show/NCT04469491

It would seem there are a few ideas out there re what 'focused' trials could mean. A more interesting theory I've heard is that it could challenge trials vs RSV, Rhinovirus etc as these would possible ethically unlike covid.

The Group is now advancing a clinical development plan for SNG001 designed to address the unmet need in targeted patient populations that appear to be most responsive to SNG001 in previous clinical trials, as well as in immunocompromised patients who are particularly vulnerable to respiratory viral infections, and also ventilated patients with confirmed viral pneumonia. This plan will start with a series of focused, investigator-led/Synairgen-sponsored studies that build a pathway towards a Phase 3 registrational programme. Preparation is underway for these focused trials to initiate in H2 2023.