Member Info for Peelweight

Copy from previous re P3 ethics situation

Phase III trial of inhaled anti-viral (SNG001) for SARS-CoV-2 [COVID-19] [UPH]

Research type
Research Study
Full title
A randomised, double-blind, placebo-controlled, Phase III trial to determine the efficacy and safety of inhaled SNG001 for the treatment of patients hospitalised due to moderate COVID-19
IRAS ID
290965
Contact name
Tom Wilkinson
Contact email
t.wilkinson@soton.ac.uk
Sponsor organisation
Synairgen Research Limited
Eudract number
2020-004743-83
Duration of Study in the UK
0 years, 6 months, 2 days
Research summary
Severe Acute Respiratory Syndrome coronavirus 2 (SARS-CoV-2) is a global threat and there is a need to assess new treatments which will prevent and effectively treat severe lower respiratory tract (LRT) illness caused by the SARSCoV-2.
Cytokines are a category of small proteins that are important in cell signalling. A certain cytokine called Interferon beta (IFN-ß) has showed antiviral activity against SARS-CoV-2. IFN-ß driven anti-viral responses have been shown to be compromised/deficient in older people and those with certain co-morbidities. Furthermore SARS-CoV-2 supresses the production of IFN-ß. SNG001 is an inhaled IFN-ß1a formulation and by delivering it directly into the lungs by aerosol it is possible to restore/boost anti-viral activity in the lungs. This has been shown in four clinical trials of SNG001 involving over 280 patients.
A pilot study of SNG001 was completed in May 2020. During this study, 101 hospitalised adults, =18 years of age, with confirmed or suspected SARS-CoV-2 infection were randomised to receive either SNG001 or placebo. Results of the pilot study showed that the odds of developing severe disease were markedly reduced in patients receiving SNG001 compared to placebo. Patients who received SNG001 were more than twice as likely to recover to ‘no limitation of activities’ from COVID-19 as those on placebo. In addition, there was a significant reduction in breathlessness in patients receiving SNG001, compared to placebo.
The purpose of this Phase III study is to confirm that SNG001 can accelerate the recovery to ‘no limitation of activities’ of hospitalised patients receiving oxygen with confirmed SARS-CoV-2. Safety and other efficacy endpoints will also be assessed.
REC name
London - Riverside Research Ethics Committee
REC reference
20/HRA/5234
Date of REC Opinion
9 Nov 2020
REC opinion
Further Information Favourable Opinion

This is publicly available on the Health Research Authority site. From my experience on another REC, the last 4 words are encouraging indeed. It basically means that with some written clarification, usually just to the chair or a virtual sub-committee (not to the whole committee at its next sitting), the study gets full approval. And it is dated 9th Nov.

I believe this strengthens the chance that if they are planning a RNS about the first recruit, it won't be long. And supports RMs statemen

Agree Meelie.

Also Type 1 error

No P3 vaccine RCT protocol would have been accepted with such low numbers. Cannot be relied on. Thus AZ going back to do P3 properly

AZ science sketchy. They announced the subgroup analysis of 90%. They did not initially announce that it was an off-protocol mistake to have a subgroup or that that group was all under the age of 55 yrs. The RCT study was not powered for this subgroup so they could only say (at most) that the overall rate was 70%. Or even more honestly say that it achieved 62% of those enrolled as per the protocol.

That would have still been positive news and wouldn’t have soured their relationship with FDA. That vaccine is still the one that is likely to successfully treat much of the globe within the next year IMO

The three vaccines have pushed SNG SP down but certainly not out!

-COVID therapeutic until hopefully not needed
-significant SARS-Cov2 mutations
-COPD
-broad spectrum antiviral
-those with IFN autoantibodies and severe viral lung infection
-Those with genetic code altering their IFN1 genes with severe viral lung infections

Docdaneeka, I'd say two reasons. Speed to recruit the full trial or to get to a clear result, which ever soonest. And the range of northern and Southern Hemisphere countries in different economic states hedges against missing COVID season/ winter in one hemisphere and against some countries achieving herd immunity against the current strain, by an effective vaccination programme. They are trying to use a crystal ball to maximise the chances of full enrolment ASAP

Thanks Mat

Believe it or not, that's is ultra quick for this sort of application of a P3 randomised controlled trial

Phase III trial of inhaled anti-viral (SNG001) for SARS-CoV-2 [COVID-19] [UPH]

Research type
Research Study
Full title
A randomised, double-blind, placebo-controlled, Phase III trial to determine the efficacy and safety of inhaled SNG001 for the treatment of patients hospitalised due to moderate COVID-19
IRAS ID
290965
Contact name
Tom Wilkinson
Contact email
t.wilkinson@soton.ac.uk
Sponsor organisation
Synairgen Research Limited
Eudract number
2020-004743-83
Duration of Study in the UK
0 years, 6 months, 2 days
Research summary
Severe Acute Respiratory Syndrome coronavirus 2 (SARS-CoV-2) is a global threat and there is a need to assess new treatments which will prevent and effectively treat severe lower respiratory tract (LRT) illness caused by the SARSCoV-2.
Cytokines are a category of small proteins that are important in cell signalling. A certain cytokine called Interferon beta (IFN-ß) has showed antiviral activity against SARS-CoV-2. IFN-ß driven anti-viral responses have been shown to be compromised/deficient in older people and those with certain co-morbidities. Furthermore SARS-CoV-2 supresses the production of IFN-ß. SNG001 is an inhaled IFN-ß1a formulation and by delivering it directly into the lungs by aerosol it is possible to restore/boost anti-viral activity in the lungs. This has been shown in four clinical trials of SNG001 involving over 280 patients.
A pilot study of SNG001 was completed in May 2020. During this study, 101 hospitalised adults, =18 years of age, with confirmed or suspected SARS-CoV-2 infection were randomised to receive either SNG001 or placebo. Results of the pilot study showed that the odds of developing severe disease were markedly reduced in patients receiving SNG001 compared to placebo. Patients who received SNG001 were more than twice as likely to recover to ‘no limitation of activities’ from COVID-19 as those on placebo. In addition, there was a significant reduction in breathlessness in patients receiving SNG001, compared to placebo.
The purpose of this Phase III study is to confirm that SNG001 can accelerate the recovery to ‘no limitation of activities’ of hospitalised patients receiving oxygen with confirmed SARS-CoV-2. Safety and other efficacy endpoints will also be assessed.
REC name
London - Riverside Research Ethics Committee
REC reference
20/HRA/5234
Date of REC Opinion
9 Nov 2020
REC opinion
Further Information Favourable Opinion

This is publicly available on the Health Research Authority site. From my experience on another REC, the last 4 words are encouraging indeed. It basically means that with some written clarification, usually just to the chair or a virtual sub-committee (not to the whole committee at its next sitting), the study gets full approval. And it is dated 9th Nov.

I believe this strengthens the chance that if they are planning a RNS about the first recruit, it won't be long. And supports RMs statement of P3 start in Q4, 2020. Well done RM/team.

If 30 is true then that is disappointing indeed. The frustrating truth is that they may only be able to advertise in the way they described in their original ethics application. So if they misjudged the route, they will have to apply for a change via an ammendment, which may slow progress. Hope I'm wrong!

Sadly, I fear that they are not the same. Although the safety data from the COPD work has been useful.

Most of the hospitalised patients in P2 would have started with healthy lungs and been struck down by COVID. Whereas Chronic Obstructive Pulmonary Disease (COPD) is ... chronic/long-term.

Good news is that COPD study to date showed SNG001 not only safe but safe with use of steroids (almost always used in exacerbations of COPD) which is directly relevant to COVID as the only useful treatment to date is Dexamethasone/another steroid.

The hope is that by showing SNG is effective in both it will be increasingly viewed, as SH sees it, as a broad-spectrum anti-viral. A much needed tool for healthcare.

But further P3 proof needed later for COPD I fear

$3000. Sorry, my bad. It is from the horses mouth, he makes a plausible-enough case for selling to stockpile without a sales force. That will keep the negotiations fairer with big pharma

Time to load up

GLA

This assumes £3000 per dose by my maths. Sounds a bit steep? I know companies charge more for “biologics”but I had been assuming a much lower price point

https://www.thelancet.com/journals/lanres/article/PIIS2213-2600(20)30511-7/fulltext

Phase 2 is published

GLA