Member Info for Matml74

Matterhorn, I thought ACTG were in charge of implementing the trial.

Frustrated by what? That the Americans haven't announced it yet? They have just had a change of government and only got their covid funding plan passed through on Friday. The trial is being run by the US so it will be announced when they have their **** sorted. Most likely this month.

They are going this route because Avacta accreditation ISO13485 won't be until end of March. Mologic already has this. It speeds up route to market. All in the RNS!

Of course they can. Its just an auditing process.

Sunday - mologic/government leak to FT.
Monday - Avacta rns partnership with mologic

Pretty obvious where this is headed.

RR, This is the latest summary of % success rates in different phases of clinical trials. IMO what will increase SNG’s % chances of success is the huge body of evidence linking covid 19 to being able to override the body’s interferon response. That and the 15 years of scientific research that the SNG team have put into getting this drug to approval stage. The strong P2 results also provides more confidence as well.

https://www.acsh.org/news/2020/06/11/clinical-trial-success-rates-phase-and-therapeutic-area-14845

Hull patient was the 12th. Re-check the BBC articles.

https://www.bbc.co.uk/news/health-55639096

It has not even been 2 weeks since the rns and that coincided with a change in power in the US and covid planning. The yanks want the P2 done with their trial protocol and to integrate into their plans for antivirals. They are funding it after all. IMO we will not be skipping P2 activ-2 but once started it will only take a few weeks to fill.

BG, What is new here?

HC, If the home trial data is compelling then I would think an EUA could occur which would be subject to continuation of the P3 hospitalised trail and then reviewed at that point for full approval. You would like to think the MHRA would be put under pressure to provide EUA considering the limited options available at present.

For reference, Activ 2 is for over 18 year old with a positive covid test within the last 7 days.

That is not what the data is looking at. Israel over 65’s showing good vaccine effect with infections dropping away from infection rates in under 65’s. This is good. It works under the two dose system and no variants.

UK data not showing same response yet. May still be too early but we will know for sure in the next week or two. 800k over 80’s were jabbed by the 8th January. Only 170k of those had two jabs.

We will hopefully see a reduction in infection rates in the over 80’s compared to other age groups soon. If we don’t then their is issues around either the single dose regime or the variants impact on efficacy or the AZN efficacy in older cohorts.

HC, I think RM learnt his lesson with the start of P3 Q4 start date and the subsequent ****storm of nervous PI’s contacting them asking what was happening so has deliberately put Q2 for readout so the same doesn’t happen again. Reality is we should hear something by mid/end of March, particularly if results show significance on primary endpoints.

The home trial won't be unblinded until the 17th February according to protocol. I am not expecting any results before later March.

Hospitalisations are not an endpoint, although may fall under contact with health services. I expect the statistical power of the study will not be able to assess death or hospitalisations similar to the P2 hospital study not being able to assess the differences in death rates.

Endpoints that will be assessed for statistical significance are below:
- Changes in daily breathlessness, cough and sputum scale (BCSS) [ Time Frame: Day 1 to Day 28 ]
- Time to clinical improvement (home setting only) [ Time Frame: Day 1 to Day 28 ]
- Time to improvement of COVID-19 symptoms (home setting only). [ Time Frame: Day 1 to Day 28 ]
- Time to self-reported recovery (home setting only) [ Time Frame: Day 2 to Day 16 ]
- Self-reported daily rating of overall feeling of wellness (home setting only). [ Time Frame: Day 1 to Day 28 ]
- Quality of life measured using EQ-5D-5L (home setting only). [ Time Frame: Day 1 to Day 28 ]
- Contact with health services (home setting only [ Time Frame: Day 1 to Day 28 ]
- Consumption of antibiotics (home setting only [ Time Frame: Day 1 to Day 28 ]

Yes trial design has been spot on despite many on here moaning about the scale and international element etc.

Nice that we also have some patents covering Lambda in respiratory viral infections.

I agree Sharestring. I find it very hard to believe that people in these positions are making decisions or are having them influenced based on some social media trolling. In fact the people I have dealt with over the years in these types of postitons don't even use social media accounts and if they did they have a team controlling them. Bethel and the like have some pretty millennial social media types controlling all his social media and I would be surprised if he even reads it. I am not condoning the trolls behaviour as obviously a well thought out evidence based comment would be a better way of doing things.

IMO, there is no way that these social media comments will have any bearing on the future of SNG. As RM says. Data is king and that will do the talking.

CO, Here are the long covid secondary endpoints for P3. I believe this is the first P3 study to investigate long covid in any detail and could prove a real point of difference for SNG001. These are all measure through to Day 90. There are also some of the other secondary endpoints around breathlessness that will be measure through to Day 90.

• Number of patients with long-COVID-19 symptoms based on General Anxiety Disorder 7 Questionnaire (GAD-7) [ Time Frame: Day 15, Day 28, Day 60 and Day 90 ]

To evaluate the efficacy of SNG001 compared to placebo in patients with moderate COVID-19 by assessing long-COVID-19 symptoms. Assessment of long-COVID-19 symptoms based on GAD-7. Scoring will be done based on how often patients have been bothered by the problems as: feeling nervous, anxious or on edge; not being able to stop or control worrying; worrying too much about different things; trouble relaxing; being so restless that it's hard to sit still; becoming easily annoyed or irritable, and feeling afraid at if something awful might happen.

• Number of patients with long-COVID-19 symptoms based on FACIT Fatigue Scale (Version 4) [ Time Frame: Day 15, Day 28, Day 60 and Day 90 ]

Assessment of long-COVID-19 symptoms based on FACIT Fatigue Scale (Version 4). The FACIT Fatigue Scale (Version 4) will include statements for patients such as: I feel fatigued; I feel weak all over; I feel listless ("washed out"); I feel tired; I have trouble starting things because I am tired; I have trouble finishing things because I am tired; I have energy; I am able to do my usual activities; I need to sleep during the day; I am too tired to eat; I need help doing my usual activities; and I am frustrated by being too tired to do the things I want to do.

•Number of patients with long-COVID-19 symptoms based on Patient Health Questionnaire-9 (PHQ-9) [ Time Frame: Day 15, Day 28, Day 60 and Day 90 ]

Assessment of long-COVID-19 symptoms based on PHQ-9. Patient health questionnaire included: little interest or pleasure in doing things; feeling down, depressed, or hopeless; trouble falling asleep or staying asleep, or sleeping too much; feeling tired or having little energy; poor appetite or overeating; feeling bad about yourself - or that you are a failure of have let yourself or your family down; trouble concentrating on things, such as reading the newspaper or watching television; moving or speaking so slowly that other people could have noticed or so fidgety or restless that you have been moving a lot more than usual; and thoughts that you would be better off dead; or thoughts of hurting yourself in some way.

*Torn

Tony, Safety of this drug has been well established through multiple trials. This trial is primarily about efficacy and also to investigate potential for long covid reduction.

IMO, Just a pause as people wait to see what happens with the BOD's decision on the special dividend. The price got ahead of itself a bit as well. I think most here are expecting somewhere between 110p - 125p by the end of the month.

Also news feeding out of SA about electricity issues may be holding this back a bit.

LT hold for me.

Everyday this week a new paper has come out about how Covid 19 inhibits interferon response and that this should guide novel treatment investigation. The science is overwhelming. MHRA heads in the sand!

https://www.biorxiv.org/content/10.1101/2021.02.04.429738v1

“ We demonstrate that SARS-CoV-2 is able to inhibit RIG-I mediated IFN-b production.”

“ Our findings provide a better understanding of SARS-CoV-2 regulation of cellular interferon response and a perspective on its use as a treatment.“