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Thanks Nolupus, just been having a read on the guidance for initiating trials and yes can see that is where the dosing would be decided. Do you know; would an assessment of different dosing levels be seen as a re-start of phase 1a-1b or would it be assessed as a delta to the original trials?
Also, i've just read that as local delivery increases drug concentration at the target site, dosage levels with an IV would probably be more than in an inhaled application anyway.
ChrisTOffer ,
Dosing levels are decided in phases 1a -1b,
That is why SNG had to go with the same COPD dosing in COVID trials to save time
Can dosing levels be adjusted for phase 3 trials? I was under the impression that one of the aims of the broader phase 3 trial would be to hone that type of thing.
Nolupus I agree that we can't change the dose for the pilot study. But depending on the efficacy data from the pilot study, i'm sure there will be a discussion of whether we have got the dosing levels optimum. Based on all the published research higher doses seem well tolerated, so there could be an argument to increase the dose for further studies to increase efficacy. Synairgen chose the dose for the COVID trial based on the COPD trial as they knew it was well tolerated. However research suggests sar-cov-2 replicates faster and the same dose may not be optimum as that for a product to treat the common cold/flu virus. Synairgen just did what was best to there knowledge at the time, but our understanding of the virus has increased, and therefore future trial designs could me optimised based on our new understandings. Obviously this will all be dependent on the data obtained from the pilot study.
correction 80% not 8% haha
Catch it early nebulise straight to the source aka lungs 8% of the market could be won outside of the hospital setting.
More serious cases may require hospitalisation and a combination of drugs which are likely to be all IV suitable and hence you might switch to IV as a preferred method for serious later stage infections for other benefits.
Once in recovery you discharge them with nebulised interferon to assist recovery at home and perhaps a repeat prescription to keep on top of lasting damage.
FOrest24,
We cannot just change dosing levels without doing other safety trials ...
Hi Nolupus, in that link that you posted they say, “The concept that’s emerging is that this is not a respiratory illness alone, this is a respiratory illness to start with, but it is actually a vascular illness that kills people through its involvement of the vasculature,”
The administration of interferons by IV may indeed help a vascular illness (IF their theory on COVID is proven to be correct), however they are in agreement that it begins in the lungs therefore reinforcing the argument that nebulized treatment into the lungs early in the illness would also have significant benefit. I don't see that link as a counter argument to the nebulised method of treatment.
Another good published piece of research :)
The dose in this study is heafty, twice as much as synairgen are using - shows we could increase our dose to provide more efficacy.
@Nopulus: the other potential concern with inhaled drugs is the issue of 'first pass metabolism' where the dose is swallowed and ingested rather than reaching the lungs which could reduce its efficacy, so there are pro and cons to different routes of administration.
GHia,
Whilst we are focusing on our theory that nebulized treatment should show higher
Efficacy .... others may say IV might be Better especially if you want to treat outside the lungs or not just the lungs ....
https://elemental.medium.com/coronavirus-may-be-a-blood-vessel-disease-which-explains-everything-2c4032481ab2
Re-Post Courtesy of Chantico these useful bits of research tend to get drowned out by chit chat.
"Interesting article in medRxiv on Thursday reporting on a trial using injected Interferon beta (IFN).
medRxiv is a medical archive that publishes preprints of medical research before peer review.
SNG's nebulized treatment should have higher efficacy than injected treatments.
Conclusion was this:
The 28-day overall mortality was significantly lower in the IFN then the control group (19% vs. 43.6% respectively)
.....significantly increased discharge rate on day 14 and decreased 28-day mortality
Bottom line - IFN works for significantly improved outcomes.
Report is here https://www.medrxiv.org/content/10.1101/2020.05.28.20116467v1
"
Fantastic stuff! I was thinking the home based trials would show the greatest benefit and that anything positive out of the hospital setting would be a bonus. That report suggests we may see very positive results from the hospital setting. I actually think the 66% to 43% discharge on day 14 is also very positive. If that were scaled up it is 20% less strain on health services.
Interesting article in medRxiv on Thursday reporting on a trial using injected Interferon beta (IFN).
medRxiv is a medical archive that publishes preprints of medical research before peer review.
SNG's nebulized treatment should have higher efficacy than injected treatments.
Conclusion was this:
The 28-day overall mortality was significantly lower in the IFN then the control group (19% vs. 43.6% respectively)
.....significantly increased discharge rate on day 14 and decreased 28-day mortality
Bottom line - IFN works for significantly improved outcomes.
Report is here https://www.medrxiv.org/content/10.1101/2020.05.28.20116467v1