The latest Investing Matters Podcast episode featuring Jeremy Skillington, CEO of Poolbeg Pharma has just been released. Listen here.
A trial will run across 150 hospitals this year and next, recruiting thousands of patients.
Flu vaccines help prevent infection but each year some people become very sick.
And antiviral tablets - given within a couple of days of symptoms developing - are designed to reduce the severity of these bad infections.
One of the pills the Imperial College London team will be testing is oseltamivir, or Tamiflu, which the government has been criticised for stockpiling and spending hundreds of millions of pounds on when there were concerns about swine flu.
It is recommended to treat severe flu - but whether it saves lives is unclear.
Funded by the National Institute for Health and Care Research, the Randomised, Embedded, Multi-factorial, Adaptive Platform Trial for Community-Acquired Pneumonia (Remap-Cap) will study how good the treatments are at reducing deaths and intensive care admissions.
The ineffective will be dropped and new ones added.
www.bbc.co.uk/news/health-63783035
Elsol the rise was most likely due to Polygon buying.
The article you posted is based from a paper published 2020
https://www.nature.com/articles/s41586-020-03065-y
Woodstock the issue with the home trial was that the placebo arm didn't get enough people getting seriously unwell and needed to go into hospital.
It wasn't powered (ie a big enough trial), so they went with the better data at the time in the hospital cohort. I think only 2 people from the home trial went into hospital in the placebo and none in SNG001. The rate of hospitalisation was c.3% and this is inline with other trials, whereas initially we expected it to be around 20%.
Activ-2 is a much bigger trial therefore although there is only a small % that will end up in hospital its will more likely be able to show statistically significant results.
“ Sir Stephen Holgate, University of Southampton professor and co-founder of Synairgen, a company that is creating Covid-19 antiviral medication, said MRI scans had also shown inflamed organs. “The body turns on itself as a result of all this inflammation during the Covid period and attacks its own tissue.”
https://meassociation.org.uk/2022/01/financial-times-long-covid-why-do-some-people-have-symptoms-months-after-infection/
“ Whether administration of exogenous neutralising antibodies is unhelpful because most people have made endogenous antibodies by the time they develop severe disease or because neutralising antibodies have little role in mitigating the pathology driven by the hyper-inflammatory phase of COVID-19, or even exacerbate it, is as yet unknown.9 We are increasingly finding indications that targeting SARS-CoV-2, whether through mAb neutralisation or with direct-acting antivirals (eg, remdesivir), might be of little importance once clinically significant lung damage has occurred (figure).3 At this stage of disease, pathophysiology appears to be driven by a dysregulated host innate immune response, and immunomodulatory therapies (eg, corticosteroids and anti-cytokine anti- bodies) targeting these processes might provide the greatest clinical benefit.”
https://www.thelancet.com/pdfs/journals/laninf/PIIS1473-3099(21)00762-3.pdf
Hi Andy,
AZD7442 is not a competitor with SNG001. They have very different patient profiles.
AZD7442 has failed every trial when targeting hospitalised patient.
Although activ-2 is a home trial there are 8 hospitals participating in Gauteng, South Africa there should be some decent numbers participating.
As Activ-2 Is and open trial there will be some very valuable data fairly quickly and considering Regeneron has failed against Omicron this will help SNG001 chances of showing its more effective than the comparator.
Under normal times this is the case however per the EMA the have introduced rolling reviews so the data will be looked at once available therefore before regulatory submission.
"Normally, all data on a medicine or vaccine’s effectiveness, safety and quality and all required documents must be ready at the start of the evaluation in a formal application for marketing authorisation.
In the case of a rolling review, EMA’s human medicines committee (CHMP) reviews data as they become available from ongoing studies"
EMA to start rolling review of SNG001 come the 15th of Dec?
Just looing at molnupiravir looks like theirs started a month ago with marketing authorisation applied for 1 month later.
www.ema.europa.eu/en/news/ema-receives-application-marketing-authorisation-lagevrio-molnupiravir-treating-patients-covid-19
www.ema.europa.eu/en/news/covid-19-ema-starts-rolling-review-molnupiravir
Winit the current trials are looking at those with confirmed Covid-19.
From our past trials there have been a small number of RSV within the COPD trial. If this is approved as broad spectrum anti viral then any patient with a viral infection will be prescribed SNG001.
There is strong evidence that SNG001 will be effective against RSV but don't just take my word here is a comment from Sir Holgate.
“Restore the ability of the lungs to neutralize the virus, or any virus mutation, or co-infection with another respiratory virus, such as influenza, or RSV (a common respiratory virus) , as can happen in winter, if Covid-19 comes back.”
Brand the paragraph you pasted in from P2 albeit correct lacks further comments from our home data analysis.
From our Home data readout
"In the Hospital Cohort (reported in July 2020) patients were 2.19 times more likely to recover to level 1 on the Ordinal Scale compared to placebo, HR 2.19, p=0.043. The addition of the 12 markedly and severely breathless Home Cohort patients changes the Hazard Ratio to 2.49, p=0.009.
Interestingly, not all hospitalised patients were markedly or severely breathless at time of treatment initiation. An analysis including only patients who were markedly or severely breathless at the time of treatment initiation, irrespective of whether they were in hospital or at home, showed that those treated with SNG001 (n=33) were 3.41 times more likely to recover than those on placebo (n=36) (HR 3.41 [95% confidence interval 1.47- 7.94], p=0.004)."
Basically if we look at those who are severely breathless at the time of treatment initiation they have a 3.41 chance of recovery. This is also at a 95% confidence level (therefore very strong). Breathlessness is also measured in Activ-2.