The latest Investing Matters Podcast with Jean Roche, Co-Manager of Schroder UK Mid Cap Investment Trust has just been released. Listen here.
Synairgen has no involvement in the LOXL2 programme except being a beneficiary of royalties (17%) on all future sales.
Thanks Ghia. Appreciated. Thought it would be the case, but just needed confirmation as I wasn’t sure whether there’d be some limitations other than the ones you highlighted. I’m no expert in that field.
Just been thinking about SNG001 being trialled for COPD prior to the arrival of Covid-19 which has now been ‘permanently‘ paused. Assuming SNG001 get’s approval as a Covid-19 treatment, it would not be wrong to assume that going forward most or a significant % of viral exacerbations in COPD patients will be caused by Covid-19 which means we can treat these COPD patients, which in return means Synairgen will be able to monetise part of its COPD market straight away as patients will be treated under the Covid-19 banner.
Those who are experts in drug licensing could you opine on the possible limits that may be placed on treating COPD patients experiencing exacerbations caused by Covid-19?
Meelie - here’s what the protocol states. [Quote] Active Comparator: Casirivimab + Imdevimab (Phase III only) Administered by IV infusion
https://clinicaltrials.gov/ct2/show/NCT04518410
gggg21 - he was on last Thursday, but his appearance is not guaranteed.
The ACTIV-2 trail end date of Dec 2023 has absolutely nothing to do with Synairgen’s SNG001. It’s totally irrelevant. The aim will be to finish recruitment for SNG001, as part of this trial, this year and data collection for primary and secondary end points will be collected during 2021 and beginning 2022.
TC Louise - the ACTIV-2 trial is managed and conducted independent from Synairgen. Their involvement is minimal to the extend it would not justify a new hire just to help with ACTIV-2.
The ACTIV trials will run for as long as it needs to until they’ve served their purpose. So it’s very possible they’ll be open until 2023.
Greenfish89 - Phase II has a placebo arm. Phase III has an active comparator. Where do you see (quote) ‘phase 2 assessing how dugs perform against each other.’ ? There is no first and second part to phase II.
gggg21 - the role’s been advertised since 04 Aug 2021 which is when I brought it to the BB’s attention.
My initial views were the same as yours. Assuming the job advert is correct then it makes no sense to make this hire as the wording specifically references visiting trial sites while we won’t have any trial sites by the time the hire is made. Based on this I’m ‘perplexed’ about the hire, provided it is a new hire.
Any of the following are possibilities or a combination of them.
1) Assuming the wording is correct the question then is whether the company is planning future trials whether that is covid or COPD related. It’s possible as RM has alluded to areas of further exploration concerning covid. Plus, the company has made a number of key hires this year which indicate they have big plans over the long term.
2) From a continuity point of view the company has to proceed as if they will do future trials. A take over might not happen. Licensing deals might involve Synairgen assisting with or partnering on future trials and as such it would make to sense for a replacement hire. Licensing might not kick in yet as Synairgen will want to reap the financial rewards from the covid play - so they should start thinking of future trials.
Either way (replacement or new) the company is planning as if they are or will become a fully fledged pharma which is great. The more mature the company becomes the better its value.
I’ve learned not to read too much between the lines when it comes to Synairgen - they’re too secretive.
gggg21 - If I recall correctly someone said, that was when we discussed it earlier this month, that it was actually a replacement and not a new role. Can't remember who the LSE member was who stated this.
Not aware of there being a rolling review, but there’s an interim analysis evaluating the primary end points at the halfway mark.
Thx for that Joey. Very interesting and informative indeed!
I’m reposting a post of mine earlier this month of an article in The Times. Some overlap with the Channel 4 documentary, but it goes more into the politics involving the WHO & China. An incredible/sobering read.
Some of you may already have read this. Quite a sobering read!
https://www.thetimes.co.uk/article/china-the-who-and-the-power-grab-that-fuelled-a-pandemic-3mt05m06n
If you don’t subscribe to The Times
https://archive.ph/sj91d
Kevinl1977 - In short here goes …
ACTIV-2 phase III: I’m cautiously optimistic that we’ll progress based on the graduation criteria and the science around IFN beta specific to our method of administration. It’s kind of ‘challenging’, based on the science, to see how it could fail when targeting the right outpatients.
Competition: Based on SNG001’s efficacy data specific to Covid-19, although not yet statistically significant, you could conclude that it would potentially be the best treatment for in- and outpatients which is quite unique. However, we should not be complacent.
Governments: We might be small, but we have well known international partners assisting from manufacturing to distribution. So I’m not worried about being ‘small’ once we deliver, provided the data is good. For example we would not have been on ACTIV-2 if we couldn’t deliver.
Take over: Difficult to say how it’ll play out. Here are the options 1) Licensing 2) Take over 3) Sale of Synairgen Research Ltd.
Be good to hear other views.
Yes you do get auto-Abs against IFN beta. Just not to the same extend as against the others.
Re not mentioning SNG001. It’s worth bearing in mind that we’ve not provided statistically significantly data from our trials and on top of that the (dodged) WHO trial from last year did us no favours whatsoever. It basically damaged the ‘reputation’ of IFN beta.
A research article published yesterday titled ‘Autoantibodies neutralizing type I IFNs are present in ~4% of uninfected individuals over 70 years old and account for ~20% of COVID-19 deaths’.
https://immunology.sciencemag.org/content/6/62/eabl4340
Some quotes:
‘We detect auto-Abs neutralizing 100-fold lower, more physiological, concentrations of IFN-alpha and/or omega (100 pg/mL, in 1/10 dilutions of plasma) in 13.6% of 3,595 patients with critical COVID-19, including 21% of 374 patients > 80 years, and 6.5% of 522 patients with severe COVID-19. These antibodies are also detected in 18% of the 1,124 deceased patients (aged 20 days-99 years; mean: 70 years). Moreover, another 1.3% of patients with critical COVID-19 and 0.9% of the deceased patients have auto-Abs neutralizing high concentrations of IFN-Beta.’
‘Moreover, the proportion of subjects carrying auto-Abs neutralizing lower concentrations is greater in a subsample of 10,778 uninfected individuals: 1% of individuals <70 years, 2.3% between 70 and 80 years, and 6.3% >80 years. By contrast, auto-Abs neutralizing IFN-Beta do not become more frequent with age.
A similar article was published in Oct 2020.
https://science.sciencemag.org/content/370/6515/eabd4570
J_CIT - ACTIV-2 is an independent trial and so Synairgen cannot make any announcements. RM specifically stated this in his last presentation.
Forward to 10:19
https://www.lsegissuerservices.com/spark/Synairgen/events/1cd87eb6-5e01-4e1a-b3bd-f8288bbb6b5b
Brighty1 – apologies that came out a bit strong.
With regard to manufacturing you need to be careful in interpreting the scale up comment in the RNS. It does not mean manufacturing scale up has commenced. It merely means that preparatory work has commenced to test the supply chain so to be in a position to scale up manufacturing at a later stage. This was clarified by RM in his full year results.
Fast forward to 12:08 of the presentation.
https://www.lsegissuerservices.com/spark/Synairgen/events/1cd87eb6-5e01-4e1a-b3bd-f8288bbb6b5b
Brighty1 - you need to do some further research.
Manufacturing did not start. Synairgen had a batch(es) manufactured to test the supply chain back to front including quality checks.
Secondly you insinuate Aerogen is designing a nebuliser specifically for SNG001. That’s not true. Synairgen is using an already available nebuliser from Aerogen.
*in vitro. Definitely not I’m. Haha
Skeletor - I wouldn’t necessarily view phase II home as inconclusive from an efficacy point of view casting doubt on SNG001 . Instead what phase II home taught us is that most patients don’t require any treatment at all. The trial was invaluable in showing us which patients would require treatment i.e. those suffering from marked or severe breathlessness. I would say they’re also most likely to end up in hospital without treatment. SNG001 showed efficacy in these patients, but as we know the numbers weren’t there to show statistical significance.
For ACTIV-2 phase II an agent need to show the following to progress to phase III:
1) Safety
2) Demonstrating early changes in viral shedding or improvement in symptoms.
Safety we know is not an issue. I’m vitro results showed we tick the viral clearance box too. So, based on this it seems that SNG001 has a very good chance to progress to phase III. (Fingers crossed.) Phase III was/will be designed to maximise the chances of achieving statistical significance by focussing on high risk patients.
Doc - I disagree re EUA for SNG001 in the outpatient space. If mABS can get an EUA then there’s no reason why SNG001 cannot, unless it fails on efficacy. We need to keep people out of the hospital or even going to a hospital.
It most definitely is just an estimation. Nothing more, nothing less.
soonbetime - the main reason why it’s taken this long in my opinion is due to the lack of urgency (in the context of a pandemic) displayed by the various countries’ Health Authorities in approving the trial. Credit should go to the UK’s Health Authorities for their quick turn around. Three weeks after the protocol was signed the trial kicked off in the UK.
Two other factors played a role as well:
1) Discussions with the FDA which seem to have caused the initial delay in Q4 2020.
2) When the trial commenced in other countries hospitalisations were on the decrease.