Samumed Sm04554 Results Normalized To Baseline

hypetraintime

New Member
My Regimen
This year, Samumed released a publication for SM04554 for the International Dermatology and Cosmetology Congress in Turkey. It contained their phase 2 results, however they normalized the hair count to baseline. The results look much more impressive then previously thought. Especially for those in the "optimal" population.

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In my opinion, it sort of makes sense why the ITT drops first then rises. Depending on where they are on the scale, for someone over 45, it will take longer for the follicles to start repairing before you see results then it would be if someone started the drug in their 20's. Someone older hs more damage to their follicles. Hence the initial negative skew on ITT, and only positive result on the optimal population.

Here is the full release for anyone who wants to read it.

They also break down how they are expecting the drug to work.

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FilthyFrancis

Established Member
My Regimen
Thanks for sharing.

The intention-to-treat sample effectiveness seems scary though.

From what I understand, Samumed is currently undergoing a phase 3 trial in Turkey with 625 subjects (supposedly launched in November 2018 based on their website).

Can anyone tell me what NH 4 means with regards to the "optimal" sample?
 

MeDK

Established Member
My Regimen
Thanks for sharing.

The intention-to-treat sample effectiveness seems scary though.

From what I understand, Samumed is currently undergoing a phase 3 trial in Turkey with 625 subjects (supposedly launched in November 2018 based on their website).

Can anyone tell me what NH 4 means with regards to the "optimal" sample?

NH 4 is Norwood-Hamilton scale, its written in the slides also provided with the link.

Norwood-Hamilton-scale-The-following-categories-are-defined-as-follows-Type-I-no.png
 

GotHair?

Established Member
If I am reading this correctly, they've stopped dosing after 90 days ( but the hair count kept increasing even after 135 days despite the fact that for the last 45 days there was no SM04554 being applied?
Also if I am reading this graphs correctly, SM04554 allows you to keep what you have when you apply 0.15% solution, but not the 0.25% solution?
So far this seems like a maintenance drug, nothing more...
 

MeDK

Established Member
My Regimen
If I am reading this correctly, they've stopped dosing after 90 days ( but the hair count kept increasing even after 135 days despite the fact that for the last 45 days there was no SM04554 being applied?
Also if I am reading this graphs correctly, SM04554 allows you to keep what you have when you apply 0.15% solution, but not the 0.25% solution?
So far this seems like a maintenance drug, nothing more...

More is not always better, other studies with other drugs have also shown the same. If you increase the dose it ends up making things worse than better.

Thats why when people on this forum writes you should just add what ever more and more things happens, then just think about the studies that shows that if you increase the dose/concentration it can make things worse instead of better.
 

hypetraintime

New Member
My Regimen
If I am reading this correctly, they've stopped dosing after 90 days ( but the hair count kept increasing even after 135 days despite the fact that for the last 45 days there was no SM04554 being applied?
Also if I am reading this graphs correctly, SM04554 allows you to keep what you have when you apply 0.15% solution, but not the 0.25% solution?
So far this seems like a maintenance drug, nothing more...

I believe they are using their drug to "restore" inhibited wnt pathway activity to levels they would be on a normal head. Not over stimulate pathways to levels which are not naturally achieved by the body.

And as far as I'm aware, more is not always better and it's possible to over stimulate the pathway they are targeting. From reading their publications and watching their conferences, it's clear their goal is to give your body the right tools to help it remember how to work properly and repair itself. A builder without a hammer is useless. Giving a builder one hammer helps them work. Giving a builder 500 hammers doesn't. Which is why a smaller concentration may be more effective.

So it seems like it's not a "concentration" type of drug, but a "how long taken" one. From these results, it could be argued that it may help restore the hair cycle to normal, and over time with a few hair cyles, begin reverse the damage to follicles. The longer it's taken, the more you reverse the damage. And when you stop taking it, your hair doesn't all just fall out. You just start balding again at a slower pace like when you were younger, but now with healthier follicles. Which may be evident from the increase in hair count even after dosing had stopped.
 

Janko

Established Member
My Regimen
I believe they are using their drug to "restore" inhibited wnt pathway activity to levels they would be on a normal head. Not over stimulate pathways to levels which are not naturally achieved by the body.

And as far as I'm aware, more is not always better and it's possible to over stimulate the pathway they are targeting. From reading their publications and watching their conferences, it's clear their goal is to give your body the right tools to help it remember how to work properly and repair itself. A builder without a hammer is useless. Giving a builder one hammer helps them work. Giving a builder 500 hammers doesn't. Which is why a smaller concentration may be more effective.

So it seems like it's not a "concentration" type of drug, but a "how long taken" one. From these results, it could be argued that it may help restore the hair cycle to normal, and over time with a few hair cyles, begin reverse the damage to follicles. The longer it's taken, the more you reverse the damage. And when you stop taking it, your hair doesn't all just fall out. You just start balding again at a slower pace like when you were younger, but now with healthier follicles. Which may be evident from the increase in hair count even after dosing had stopped.
Stimulating WNT is quite tricky. Overexpression can lead to cellular damage, in some cases even DNA damage. However, WNT signalling is quite fascinating and the more I read about it the more hope I have in this. There are some studies on correlation of prostaglandins, especially PGE2 and PGD2 and WNT pathways. WNT signalling also play some role in stem cell control. WNT might really be the way for a new treatment. Maybe even a cure.

This treatment you can easily compare with chemotherapy against cancer. More is not always better. Getting the right strength of chemo is also quite tricky. Maybe there is some need to set the right stimulation of wnt individualy. Someone could benefit more from stronger substance, someone from weaker one.
 

hypetraintime

New Member
My Regimen
Stimulating WNT is quite tricky. Overexpression can lead to cellular damage, in some cases even DNA damage. However, WNT signalling is quite fascinating and the more I read about it the more hope I have in this.

Yeah true. The WNT approach is Samumed's claim the fame. They claim to have found a way to signal the pathway while avoiding the scary stuff. It's still good to be cautious, but from looking at their pipeline and what they have published, it gives me confidence seeing that they seem to have a platform to address many degenerative diseases related to aberrant Wnt pathway signaling. They don't just have a single drug they stumbled upon. This may hint that they know something fundamental, that everyone else does not.

My advice would be to use everything you are willing to now to minimise the damage to your follicles until this comes out. Because it's possible this drug might repair the follicles that Minoxidil/finasteride are trying to maintain, and you might be able to stop taking them.
 
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MeDK

Established Member
My Regimen
If you look into their Phase 3 study they aim at NH 3V - 4 which looks like to focus on the vertex area (which phase 2 called NH4 most optimal). Just like Minoxidil is most effective on those areas.

So could be interesting if its only a vertex topical, and doesn't work on temples, or they just are focusing on the best results with their optimum group which is NH4
 

hypetraintime

New Member
My Regimen
If you look into their Phase 3 study they aim at NH 3V - 4 which looks like to focus on the vertex area (which phase 2 called NH4 most optimal). Just like Minoxidil is most effective on those areas.

So could be interesting if its only a vertex topical, and doesn't work on temples, or they just are focusing on the best results with their optimum group which is NH4

Just because NH 3V - 4 is in their inclusion criteria definitely doesn't mean they are only targeting the vertex.
 

Janko

Established Member
My Regimen
Yeah true. The WNT approach is Samumed's claim the fame. They claim to have found a way to signal the pathway while avoiding the scary stuff. It's still good to be cautious, but from looking at their pipeline and what they have published, it gives me confidence seeing that they seem to have a platform to address many degenerative diseases related to aberrant Wnt pathway signaling. They don't just have a single drug they stumbled upon. This may hint that they know something fundamental, that everyone does not.

My advice would be to use everything you are willing to now to minimise the damage to your follicles until this comes out. Because it's possible this drug might repair the follicles that Minoxidil/finasteride are trying to maintain, and you might be able to stop taking them.
Since WNT play major role even in embryonic development I am not surprised it might be a key to some diseases.
Although, it confirms my father claim. He is in quite high position in one big pharma. I asked him why don't they do some hairloss research, that there is huge market potential. He said, that there are several points why big investments into hairloss research are not that common:
1) Most of us don't realize, that skin itself is also organ. And to force organ to repair some part of it or deal with inflammatory problems is right now almost impossible. e.g. Crohn´s disease
2)Need for rentability. Research is expensive as hell and as stated in point one, dealing with hairloss is not that easy. You won´t get any funds for it. If you by luck find something that works you might be forced to make it expensive as hell to get the money back, so on open market you would reach only few customers. Pharma companies like mostly treatments and cures, that can be covered by health insurance. Hair loss is not and will probably never be covered by insurance.
3)If you consider 1 and 2 you get to final point. Hair loss research is expensive as hell, difficult to achieve results therefore not guaranteed payback and it is not covered by health insurance, so even though you find something it might not pay off. Therefore hair loss research will be mostly possible as a collateral research with other researches with similar approach, substance etc.
 

hypetraintime

New Member
My Regimen
The intention-to-treat sample effectiveness seems scary though

How so? It looks as though someone who is over 45 has more damage to their follicles so it will take longer to repair. In contrast to the younger patients which start seeing results almost immediately. It looks fine.
 

Mightyduck

New Member
My Regimen
As soon as the phase 2 results came out for SM04554 a lot of people seemed to get disheartened by them. But honestly as soon as I saw them I got hyped because I noticed that this stuff kept giving hair growth even after the participants stopped applying it. I have a feeling that this stuff will keep giving you improvements for as long as you use it cause looking at the diagram it looks like with the main culprit, DHT, which prevent 'nutrients' from reaching your hair follicles, resultantly leading to de-miniaturization, this stuff SM04554, indirectly increases the wnt pathway which leads to hair growth which ultimately reduces the effect of DHT and leading to your hair follicles being able to receive those essential 'nutrients' again and stopping miniaturization in it's tracks------if everything goes to plan this will be available in turkey in 2021 :) We're getting close my hairloss brothers!!
 
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Seuxin

Established Member
Why waiting for the release ? You can already buy it 1gr and at 0.15% it will last you long time.
 
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