The latest Investing Matters Podcast with Jean Roche, Co-Manager of Schroder UK Mid Cap Investment Trust has just been released. Listen here.
One more site added which brings us to 15 approved sites in India.
http://ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=53300&EncHid=&userName=SNG001
If the link does not work use this one and use 'SNG001' as the 'Keyword' http://ctri.nic.in/Clinicaltrials/advancesearchmain.php
Doc - I get what you mean. Having to treat 10% to prevent only 2% - 3% from being hospitalised. On the face of it, it does sound like an expensive exercise, but only if the treatment is expensive.
The answer to this question is value based and therefore depends on what you are trying to achieve which would include considerations such as, but not limited to:
1) Prevent undue pressure on the health service.
2) Cost - Non hospitalisation is far less expensive than hospitalisation.
3) Potential for reduction in long covid - we’re awaiting results.
4) Fewer hospitalisations enable Health Services to focus on non-covid patients.
5) Prevention of death
The ‘cost’ of such considerations may or may not exceed the cost of treating the 7% - 8% ‘who don’t seem to require it.’ It’s definitely a multi faceted equation and one for the Health Authorities to figure out. At present I’d say they would opt for treating the 10% especially in the US. Could be different in the UK and EU, but with the NHS waiting list in the millions you want to keep people out of hospital at all cost.
About 10% of people develop marked or severe breathlessness and only about 2% - 3% are hospitalised. (Note it’s not 2% - 3% of the 10%.) The latter was confirmed by the phase III trial for BRii where they had just under 3% hospitalised if I remember correctly. Their trial covered a few thousand patients.
I’d say he’s saying the same thing in this interview - maybe not the best choice of words by either RM or the journalist.
A discussion about SNG001 with specific reference to its target audience and a few comments from RM. It’s discussed in the section called ‘Helping too few’ - the header references the home trial.
https://www.sciencenews.org/article/coronavirus-covid-19-why-early-treatment-drugs/amp
I think it’s important to put into perspective part of the sentiment displayed here yesterday.
We’ve known for a long time now that SG018 results are expected in H2. So that’s a non issue. The trial completion dates are of course only estimates and they may change as and when the company learns more about the actual recruitment rate. What is of importance though is the breakdown of those dates and to ensure they’re correct. (For example your primary and trial completion dates can’t be the same for SG018 - the definitions for these two are very clear as per the NIH clinical trial register.)
The reason why the breakdown of these dates OR when the trial recruitment end date is pushed back, like we learnt yesterday, is important is because they provide you with the ability to gauge the perceived risk pertaining to the following two risks.
1) Commercialisation: In order to take full advantage of the upcoming winter season we need to be in a position to sell and ship product before the winter period starts. That can only happen if results are announced and authorisation granted which then will trigger orders and ultimately triggers manufacturing. This does not happen in a day or even a month. So with a recruitment end date of 01 Oct you’ll have a read out in Dec. Unless, we have meaningful levels of stock we will not be able to take full advantage or potentially much advantage of this winter season. We do have stock, but what we don’t know is whether they’re meaningful.
Our main markets which are the US, UK and EU all have their winter during the same period so there’s no natural hedging.
2) Competing therapies. (Not going to to further detail on this.)
The commercialisation risk definitely increased with yesterday’s news. That does not translate into SNG being a bad investment or one worth dropping. It merely means that the potential upside could be limited.
Does it mean these risks will materialise. No it doesn’t. Events may occur which mitigate or eliminate these risks. Irrespective, it’s important to be aware of these risks and to evaluate them on an ongoing basis.
Peelweight - question re your first caveat. Does the detailed trial protocol need to explicitly state early termination as a possible recommendation when it’s unethical to continue due to proven efficacy or is it standard across trials?
Matml74 - agree RM always stated H2, however that is no excuse for continually publishing incorrect dates. For example one set of dates suggest a top line read out in Q3, which we now know won’t happen, while another suggests Q4. That’s quite a difference.
I am just someone who values things being done right.
The dates don’t make sense. I find it frustrating that whoever is responsible for updating the protocols continue to put incorrect information out in the public domain despite informing them twice about it via Consilium.
You can’t have a recruitment end date of 01 Oct with a overall trial completion date of 05 Nov. There should be a 90 day gap between the two dates. 05 Nov could be the primary completion date, but what are we supposed to believe?
Doc - that’s my biggest concern re Synairgen which could cost us dearly. It’s a risk mentioned in the annual report and it’d be great to know how the company is managing this commercial risk. In my view if interim data is strong & promising then we simply cannot wait to do a readout after analysing the full data set. I base this on the assumption that the risk of the final results being materially different from interim results being low.
Thanks for that Joey. That’s grand of you to share.
mact4 - correct. 24 weeks refer to the period during which both the primary and secondary endpoints are being measured (per patient) from date of enrolment. So the full study still has a LONG way to go.
However, top line data would be released as soon as it’s known. Primary end points are measured through day 28.
Matml74 - thank you. Will have a read.
'A weak production of INF-ß along with an exacerbated release of pro-inflammatory cytokines have been reported during infection by the novel SARS-CoV-2 virus.'
'Previous reports have demonstrated that SARS-CoV-2 N protein, along with some non-structural and accessory proteins, efficiently suppresses INF-ß production by interacting ...'
'In the present study, we better characterized the mechanism by which the SARS-CoV-2 N counteracts INF-ß secretion and affects RIG-I signaling pathways.'
https://www.mdpi.com/1999-4915/13/8/1439
It’s always been like that i.e. phase 2/3. It’s how the trial’s designed.
Matml74 / other expert(s) - as you mentioned this article focuses on IFN alpha, but do you think or is it possible to deduce that IFN beta production may also be affected post covid-19 infection due to the DC deficiency?
*and
UW has been recruiting since April. It’s just another call out for patients. Nothing more an nothing less.
He’s referring to SG016.
Exactly that yes. The ‘original’ primary completion date was 01 Jun which got pushed out by four months. Even Jun was probably later than originally envisaged since the trial was supped to start end of Nov. Hopefully they factored in a delay of at least six months when they crunched the numbers for the fundraising.
TrekMadone - reducing the number of patients required for SG018 from 900 to 610 should have saved us a few quid. Must be a few million as the trial budget was £30m if I remember correctly. This cost saving would come in quite handy.