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Matt that's correct, that's my understanding of it.
Whether you're in the first cohort of patients who are severely breathless at home, who pick up the phone, get directed to hospital by emergency services and then get assessed on the same day in an ambulatory unit for example, you can still get discharged home to complete outpatient treatment and not be hospitalised. These people get assessed by us and discharged on the same day with courses of antibiotics and oral steroids all the time so there's no reason they couldn't be sent home with a course of SNG001. These people would therefore still fall into that 10% category that RM alluded to.
If you're in the second cohort of patients who end up being admitted due to an increased oxygen requirement then chances are you'd be kept on the ward until you're stable enough to be sent home to complete the treatment anyway.
Remember the same happened in the results presentation. It’s not his trial so I guess he’s just not going to mention it.
Matt. I agree that recruitment is the most obvious and likely reason for delay with progression. Your last point is also unarguable and answers the points that came up in my conversation with the journalist.
Still odd that even en passant RM doesn’t mention that the co may still have an outpatient iron in the fire - particularly talking to a US journo
The following should be borne in mind based on some comments/assumptions made .
1) ACTIV-2: To progress to phase III a drug needs to be safe and secondly demonstrate early changes in viral shedding or improvement in symptoms. SNG001 already proved safety while the in vitro tests showed SNG001 to have potent antiviral activity. Based on this you could suggest SNG001 shouldn’t have an issue progressing to phase III. But, the point I wanted to make is to highlight the graduation criteria.
2) Bear in mind SNG001 was one of four agents trialled in ACTIV-2 phase II and was later joined by another three agents. All competing for patients while the virus was in decline coupled with suggestions that they struggled to recruit patients. This could in part explain why it’s taking so long to complete recruitment.
3) My understanding of SeaBoy’s post is that a patient would be admitted to hospital, immediately assessed and sent home the same day with SNG001. (Correct me if I’m wrong SeaBoy.) It’s like going to your GP. That does not count as hospitalisation. That’s outpatient. The lady from Hull spent a few days in hospital before being sent home which does count as hospitalisation. Need to distinguish between these two scenarios.
4) RM made it clear with the release of the SG016HOME results that the company will not, on its own, be pursuing further trials for outpatients.
Good discussion on this here. Don't overlook the safety data though - whatever is collected in this regard during trials will be needed and also invaluable if the drug is to treat future/other respiratory pathogens. Efficacy is one thing, safety data is another. The more data produced on this the better IMO so it's not just about how and when to use the drug but proving safety. And yes, I know we all beleive the drug to be safe, but for regulators data is king.
I understand there other biomarkers including genetic (disease prognosis due to interferon deficiency i.e. defective genes ) other than breathlessness
It still achieves this Prion - albeit with a start point in hospital. NHS is protected if patients don't move from Covid wards to ICU - and then go home earlier (6 days against 9 days in SG016 Hosp)
Greenfish - good point. I still say the likelihood is that we have progressed on Activ-2 as it's been so long - and they can change the protocol for P3 to give a better chance of success - but I can't see EUA or a big pre-order without the international P3.
It should still work as most admissions to hospital with covid present with breathlessness. It's just seeing that trend from a home trial requires a lot patients as only 5% before the vaccine got admitted. Who knows how low the percentage is post vaccine?
Good debate. Merit on both sides of the argument.
We found that out from our home trials. I'm not surprised I was hoping they could of pivoted to a more Ill cohort or one with breathless symptoms. Maybe if the sample is big enough then a significant amount will develope breathlessness and we can get the good data that way.
Maybe that's why it's taking so long?
Disappointing that you infer Sng001 might not prevent hospitalisation and ease the burden on NHS as I thought this was a key advantage of the drug being administered at home. Also coupled with the Delta virus not shown breathlessness as a an early symptom perhaps that is why RM is a more down beat .However given the greater transmissibility and infectiousness of Delta will this make theme rethink the use of Home treatment .Is this why things are taken longer on Activ 2 ?
Thanks Doc. That is what I understood from your previous comments.
As our trial has not been closed due to futility, as with some others, there is still a possibility of positive news on the Activ2 front, though perhaps not as stellar as previously expected. Fauci has said in the past that he wants to keep people out of hospital. However, it does raise the question though, if SNG001 is best placed or first administered in hospital (stabilise patient and send patient home to complete treatment), should we perhaps look out for SNG being moved into one of the other Activ trials?)
But I see that now the greater weighting will come from our current international hospital trials.
mact i’m more of a layman than anyone else on here - I’m not saying we won’t progress and plenty of properly qualified posters are convinced we already have. I believed Dr Mario when he said we have. We do know however that anyone over 18 can enroll on Activ-2 and that we weren’t getting the sickest patients so it might be even more difficult than our own HT
Doc, the consensus at the time that she was first dosed was that her and other patients like her would be treated in hospital first, shown how to use the drug at home, and then sent home to complete the course of treatment.
If I remember correctly she was shown how to use it by the research nurses and the staff nurses on the ward which would imply that she was indeed sent home to finish the course. So yep, I'm definitely not worried about our applications.
Thanks for explaining this is layman's terms, Doc.
If I may clarify, you are suggesting that it is possible we may not see stellar results for Activ2, as hospital then home setting may be best place for SNG001.
Candid I'm with you and have said this many times. Always believed our future is as a hospital treatment and also think we need to be ready for the possibility that SNG does not progress on Activ-2, treating it as a bonus if we do. Many will say we'd have been chucked off already if it wasn't showing a strong enough signal and this may be true but for the reasons you point out I can't see widespread home use until something like the bio-marker testing arrives to show more precisely who is going to get seriously ill. Breathlessness is not a good enough indicator and nobody with severe breathlessness is going to stay at home.
RM said this himself in the Science News interview that was posted on here last week. It's his most recent interview anywhere.
"About 10 percent of people will develop concerning breathlessness and some may end up in the hospital. But it’s so relatively few that you would need to treat a huge number of people just to stop one or two from landing in the hospital, Marsden says. “That’s the quirk of this virus,” he says. "
The journo confirmed to me that the first part of the paragraph was her paraphrasing of what he said and not a direct quote. I asked her to clarify this further
Doc "Richard seemed to be suggesting that even for SNG001 early treatment of Covid would be a largely futile - or at least impossibly expensive and large scale endeavour before the second week of symptoms "
She replied to say
"yes, he said that the company has decided not to pursue at-home treatment and will be moving forward with trials of the treatments for hospitalized patients. "
Now I took a deep breath when i read this and asked her one final question about whether they'd discussed Activ-2.
Her reply "Richard did not mention it"
"The company has decided not to pursue at home treatment" is an incredibly blunt and unequivocal statement considering that SNG is still being investigated in ambulatory patients in the US (where the journo is based) and we're all so hopeful for activ-2 but I think the context is that the interview was specifically on the subject of Synairgen's own trials - and the difficulties of the Home Trial in particular - and on second reading i decided he was just telling the literal truth about Synairgen's own trials. Bit of a shock when i read it though !
Seaboy wasn't our first P3 patient - Alexandra Constantin in Hull - sent home to complete her course of treatment ? Have i remembered this correctly ? If so it shows that your hypothesis is already correct. 4 or 5 days of hospital treatment and then clear the bed and off home to recover fully
Fwiw I would think going forward ( ... and thinking globally rather than domestically) ... that being pro-active will be large part of healthcare to protect against/limit hospital admission. Also consider dealing with remote communities, care homes and clinics dealing with the elderly and simply countries with limited hospitals, and equally limited capacity and capability so waiting until symptoms develop is not an option. All of that means stockpiling and having reserves. All imho.
Hi Candid. This is a good point to raise and I'll answer it from the clinical point of view.
When we assess these patients over the phone or in person and they're suffering from breathlessness, then you're right. We would have a tendency to send them in rather than keep a breathless patient in the home setting. That's if we saw reason to and there were other confounding factors such as possible infective markers, systemic signs of deterioration, and the general feel of a patient that's going to decline rather than improve if left alone which is a skill we learn to hone over the years. Keep in mind though that not everyone experiencing breathlessness at home is going to be sent to hospital. Think about the asthmatics and COPD sufferers who suffer from breathlessness all the time - they live with the symptom on a daily basis and know what a deterioration feels like and aren't going to be rushing to hospital as soon as they feel out of breath. The average asthmatic would probably reach for their inhaler first rather than the phone - if they weren't having a crisis that is.
Let's say that the patient does end up in hospital. I'd say that once we've assessed them, seen that they're hemodynamically stable, don't have infective signs such as lung sounds or infection markers in the bloods, and lack other hallmarks of severe disease such as cardiac abnormalities or pulmonary emboli for instance, then there's scope to send these patients back home with a course of SNG001 and a sats probe and ask them to monitor their sats on a daily basis. We send patients home with antibiotics all the time after we've assessed them and we make sure they continue to monitor at home while taking the treatment.
Of course there's still work to do to identifying the specific 10% cohort that this drug may be aimed at in the home setting, but there are ways.
I disagree with the 'severe stage' Peelweeight,
If I'm sat at home on my sofa and I'm struggling to breath, I'm going straight to the hospital - panic would set in.
Candid, I share your confidence for P3 and your concerns that it seems less likely we'll end up being a significant pre-hospital treatment.
However I want to point out that what RM said about marked or severe breathless patients might have legs in the home setting. Definitions
Marked breathlessness - noticeable when washing or dressing
Severe- almost constant, present even when resting
Many patients will still be at home at this stage of COVID. It is possible to be that breathless and otherwise coping ok at home. Especially marked. For that reason, I haven't written off home treatment yet. Neither has ACIV 2 as far as we can see. Don't lose sight of the fact that our HT showed these are the very ones that end up in hospital, a fact that will be well noted by A2. All IMHO
Activ-2 is also about stopping viral replication. It seems the blunting of the interferon response is now being linked to long covid as highlighted in the Telegraph today so there is more to it than just dealing with breathless patients. Stopping viral replication in it's tracks whilst propping up the innate immune response may go a long way to limiting the impacts of long covid. Getting the signals on this will require a large trial data set and think SNG will progress on Activ 2 for these reasons. If SNG001 stops viral replication in Activ-2 P2 phase it will progress to the next phase.
I could be wrong, but it doesn't seem to me like early intervention is not helpful, but more like it's hard to show the statistical significance in a trial where (thankfully) most people get better anyway, even among the relatively elderly, because the numbers on the trial were not massive, so the contrast with the placebo group wasn't either (but it was zero deaths and hopitalisations in the Synarigen group wasn't it, which is better than what vaccines are now achieving, if it were to continue to be the case).
Maybe things will develop in terms of biomarkers that identify those who would most benefit from the treatment too, to the point it could be delivered after positive tests and mild symptoms, or at least before hospital admission if the data 'proves' it is more effective than current hospital treatment. But being used as a go-to therapeutic for new, breathless, hospital admissions is an alternative route I suppose, maybe for a split strategy of at-home and in-hospital Synairgen Covid treatment?
I’m a fan of what SNG are developing and am confident of a positive read-out of the pivotal Phase 3 hospital trial.
As regarding the Home cohort element of treatment I’m not so sure. Following the UK home trial results the company have concluded that some benefits were seen only in patients who are markedly/severely breathless and that any future treatment should be targeted on patients who have had a breathless assessment. In the real world I just can’t see how this will work in a home setting as any patients that have developed breathlessness will not hang around at home and are currently advised to contact emergency services for hospital admission. I just can’t see any patients taking the risk of staying at home without the support of a hospital environment for treatment at this stage.
In my opinion the Active-2 trial will likely produce similar results to SNG’s own Home cohort trial and this could pose a risk for Active-2 not progressing to a phase-3 element. I could be wrong as some targeted patients could be sought but in my opinion this will be difficult to carry out.
Treatment in the hospital environment looks the most likely path and I am confident this will have a positive outcome.