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Wife and son asthmatic. Wife copd and IBS! . Big big need for new effective medication. Can’t carry a massive inhaler bottle around-the one they give out. Have to rely on puffers.
4D has irons in many fires.
Asthma and IBS huge markets. IBS very promising as it is in the gut-a natural place for 4D’s applications.
As a Seretide twice a day man, this is a really interesting post, so thank you.
I think another aspect of this is psychological. I think some people (even asthma sufferers lump all inhalers in with Ventolin and therefore don't see them as an ongoing preventative medicine. If they can find another way of administering it it might be more in line with other medicines they take that they understand to be preventative (even the pill etc). You would have more experience of this but it would also seem fair to assume that it would be cheaper and better for the environment to produce capsule's than manufacturing an inhaler.
Yes, that's pretty much it. If the patients either don't take their preventer or take it incorrectly to manage the airway inflammation, then they end up relying on the emergency Ventolin. How many times a week the patients take their Ventolin is a good marker as to how controlled their asthma is and is one of the main questions on the Asthma Control Questionnaire (ACQ) which they use to monitor how controlled a patient is.
GSK ran a study called the GOAL study which showed that it is possible to achieve total or well controlled Asthma using some of their medicines (AZ et al. have similar studies with their inhalers). Patients were enrolled and given lessons on exactly how to take their inhalers and had to keep a record to show that they had actually taken it. The results were very good i.e. they managed to control the inflammation which resulted in the Asthma symptoms or lack of in these cases.
If MRx0004 can control the inflammation and 4D can create a capsule with it to taken once or twice a day. It would certainly much easier for patients to take and would immediately remove the inhaler technique issue. A game changer for patients and their wellbeing which massively impacts their lives and it would be worth a figure that I could not even hope to guess for 4D in terms of revenue.
Appreciate it isn't the lead candidate and MRx0518 gets a lot of the attention but it's another string to the bow and could be a very important discovery for the company going forwards.
Interesting points Richie.
I haven't done as much research around the asthma treatment as I have with say oncology. From previous comments by DP I think 4D critique the common model of asthma that is focused on treating the symptoms in favour of one that addresses the root causes. They are looking to treat the 2 main asthma phenotypes , neutrophilic and eosinophilic where there's severe unmet need in neutrophilic for cases classed as severe.
DP also stated previously that before 0518 began to be studied the asthma candidate was the one generating the most excitement amongst the 4D scientists.
There seems to be some doubts now around the use of the maintenance therapies with suggestions that over reliance on them and reducing reliance on short term/emergency relievers is leading to more exacerbations and hospitalisations.
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Secondly is inhaler technique. It’s really hard to get it right and if they don’t, the steroids end up on the tongue or back of the throat and it never actually get to the airway. Even with good technique, only 10-20% (from memory) of the drug gets there anyway so the doses are always higher in the inhaler then would be effective in an invitro setting to take account of this. If inhaler technique isn’t good, then it’s practically 0 so utterly pointless taking it anyway.
It also takes quite a bit of coordination and a few minutes to dose yourself correctly, people just blast it in twice, breath in and think they have done the job and taken their medication. Poor inhaler technique is very prevalent among asthma suffered and the time it takes the asthma nurse to teach each patient how to do it correctly is often wasted as people are busy and just rush through it once they get home.
IF this works (and we’re all here hoping it does) and they can either supplement the steroid inhalers or eventually swap them out for some patients with an easy to take capsule. The opportunity here is actually mind blowing. GSK, AZ, Boehringer etc have all had blockbuster and I mean mega mega blockbuster respiratory inhaled drugs.
The study is looking at patients with an FEV1 of >50% so these would generally sit it in the mild and moderate asthma patents which make up the largest cohort of sufferers.
Does it work and can the data be replicated in a phase III? I’ll certainly be here in a few years to find out.
Good luck and ATB.
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I was just having a more detailed look at the ongoing asthma trial as I know we’re expecting a top line readout in Q4 at some point. I used to work for GSK in respiratory disease so this one has a bit of extra interest for me as I know a decent amount about Asthma and COPD.
For those who haven’t had much experience with asthma, the ultimate goal when treating asthma is to achieve ‘control’ which allows patients to pretty much live their normal lives as if they actually don’t have asthma – It’s tough to achieve this but it is possible with the right medication. In most cases this is done though inhaled corticoid steroids (brown, green, purple, red inhalers) as a maintenance usually taken twice a day, plus a bronchodilator for emergency use (blue inhaler). Pretty much everyone will have seen someone puffing on a blue Ventolin at some point when they are wheezing or having an asthma attack.
The current treatments that are available are very effective but there are two massive issues that really mess it up and make it hard for patients to achieve control.
Firstly, patients just stop taking the inhaled steroids. Despite Dr’s best-efforts, patients don’t really fully understand how it all works. They take the Blue Ventolin and it makes them feel better instantly, the inhaled steroids don’t ‘feel’ like they do anything and they only work if they are taken regular as clockwork over months and months. Like tipping a little bit of water on a fire twice a day to keep It down (inflammation of the airway).
After a while people just forget and resort to the Ventolin when they feel a tight chest, they treat the symptoms by temporarily opening their airway and not the actual disease. It literally takes months and months of the tiny doses of steroids every day to stop the airway reacting and closing every time the patient comes into contact with a trigger like animal dander, smoke, pollen etc etc.