Samumed- Sm04554 Phase 2 Results Safety And Biopsy Outcomes

[distracted]

People are so damn picky this is ridiculous.... How much hair growth did the first trial have? Like 10%? In 6 months? Isn't that equivalent to finasteride without side effects? I'd be fine with that cause then atleast ill know my did still f*****g works

Picky? Where in the above chart do you see a 10% increase in density?

I'm no expert in reading graphs like these, I honestly have zero experience, but wouldn't one think that there would be some consistency between the .15 and the .25 solutions? In some hair counts the .15 outperforms and in the other the .25 does. Also, probably the most important chart is the 'terminal follicle count' where the .25% solution show a decrease in terminal hair count.

These results were totally underwhelming. May be a customer at some point but certainly not overly-hyped about this.

 

[paxis]

People are so damn picky this is ridiculous.... How much hair growth did the first trial have? Like 10%? In 6 months? Isn't that equivalent to finasteride without side effects? I'd be fine with that cause then atleast ill know my did still f*****g works

Afaik in only 3 months.

 

[nameless]

Picky? Where in the above chart do you see a 10% increase in density?

I'm no expert in reading graphs like these, I honestly have zero experience, but wouldn't one think that there would be some consistency between the .15 and the .25 solutions? In some hair counts the .15 outperforms and in the other the .25 does. Also, probably the most important chart is the 'terminal follicle count' where the .25% solution show a decrease in terminal hair count.

These results were totally underwhelming. May be a customer at some point but certainly not overly-hyped about this.

This in highlights. I see the same thing and it doesn't make sense to me either.

I think that some of the changes in hair counts could be the natural shifting of hairs between anagen and telogen or these doses aren't high enough so the treatment is sort of sputtering and unsteady. I think they should increase the dose to see if a stronger dose produces more steady and sensible results.

 

[infinitepain]

What sense does it f*****g make that the higher dose makes the line go down? so why are you saying an higher dose will go better? maybe its even worse.
Its just like finasteride, more doesn't mean anything. God this sucks.

 

[hairblues]

i honestly cant understand the chart I'm waiting for cliff notes.

 

[infinitepain]

the results seems to indicate the following:

• using vehicle (control), there was a drop from 34.2 to 23.6 by day 135, which is a ~31% drop in density
• using 0.15% solution, there was an increase from 36.9 to 38.9 by day 135, which is a ~5.4% increase in density
• using 0.25% solution, there was an increase from 40.5 to 41.9 by day 135, which is a ~3.4% increase in density

If you were to go by this, it would seem to indicate maintenance was achieved, and even some minor gains obtained. It is interesting that with the 0.15% it takes longer than 90 days to see gains, which seems normal when dealing with hairloss - 0.25% seems to get gains earlier.

How can you even tell ~5.0% increase in density is because of this drug and not due normal hormonal fluctuations and natural hair cycles that occur in 135 days?

 

[infinitepain]

Looks like we are going to be stuck with a 1997 tranny drug for the rest of our lives as the pinnacle of hairloss weapon.

 

[ForeverBald]

So basicly this stuff is BS right?

 

[Afro_Vacancy]

It's a maintenance drug with a completely independent mechanism. Would probably be great in combination therapy.

 

[hairblues]

i forced myself to read it.

Im not sure why people are sour about it...i'm not a science person but from what i gather its at the very least (potentially) good for maintenance and some regrowth. Neogenesis is a specific term for new follicles, no? so eve if its just 'some' thats good.

for me for instance i have some regrowth with minoxidil that i would like to see get thicker.

i would also like something besides hormone blocking drugs to maintain.

did i miss something? (not being wise as genuinely asking)

 

[Ikkaku]

This + Follica will be an awesome combo.
Don't forget synergy with many drugs.

 

[nameless]

What sense does it f*****g make that the higher dose makes the line go down? so why are you saying an higher dose will go better? maybe its even worse.
Its just like finasteride, more doesn't mean anything. God this sucks.

It's very hard to respond because you're saying things that are contradictory.


1. Yes, you're right that the higher dose made the line go down (meaning worse results).

2. But you also say that it's just like finasteride because "more doesn't mean anything".

These two statements are contradictory because first you say more medicine causes worse results and then you say more medicine doesn't mean anything. Since more medicine caused worse results that means more medicine DID mean something. So SM04554 is NOT the same as finasteride when you use more medicine.

And I don't think increasing the dose should cause worse results. I could understand if the increased dose was no better than the lower dose but I don't understand the increased dose causing worse results. These results look erratic to me so I think there's a small chance that the medicine is having an effect but may not be a high enough dose at least for some people.

For all we know the people who did the worse were the people with more hair loss and/or were losing hair longer. I think they put people with advanced hair loss to very advanced hair loss in this study. The subjects were NW4 - NW6.

Plus the study size may be too small. If you have a small study and one or more of the treatment arms is weighted with poor responders that could throw results off quite a bit. I think this study was small.

In small studies stuff like this can happen.

 

[the smoking baby]

I think it should also be noted that the biopsy at the 135 day mark was optional so perhaps not all test subjects had the second biopsy done. There could have been even more improvement at that stage which didn't show up in the results.

 

[nameless]

I don't like this study at all. I don't think it makes sense. I think it was a mistake to exclude lower NWs. I think it was a mistake for them to put subjects with major hair loss in the study because it could take a lot more medicine to reverse hair loss for a NW6 than a NW4. Or it would have been OK for them to put NW4, NW5, and NW6 in the study but when they unblinded the study they should have done a breakdown of how each of the different Norwood grades faired and what dose or placebo each subject was on.

 

[shookones]

If this was minoxidil the results would be far worse due to the initial shedding.

I'm impartial until I see 1 year results.

 

[nameless]

The patient's ages were 18-65.

 

[nameless]

I think there were

19 subjects in the vehicle group

16 subjects in the 0.15% group

14 subjects in the 0.25% group

For a total of 49 patients.

But I don't see a breakdown of each subject's results, each subject's dose/placebo, each subject's age, and each subject's Norwood grade. And without this information we can't make a fair judgment about this stuff.

 

[Grasshüpfer]

Also the 135 day measurement was "optional". Yet already from slide two it is treated as perfectly valid information.
With a sample size of ~10 already one guy deciding not to show up because it's obviously doing nothing can mess up the numbers.

The 90 days timeframe is a joke. At three months on finasteride you see nothing except of major shedding in good responders.

At 90 days in the study you see no results at all due to poor study design. That would have killed the product and layed off the whole team. So they duct - taped in another measurement point.

This study is designed to keep us waiting and their research going.

So yeah, it seems like the stuff is doing something but will come out in 2030.

@Noisette
I really love to see your avatar pop up. It always means amazing finds. Thank you!

 

[Gone]

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2939833/#!po=35.7143

I remembered reading something before about too much Wnt activity causing hair loss, so I found the paper and linked it above. Excess beta-catenin can result in stem cell depletion, so maybe this has something to do with the higher dose being less effective (at least in terms of terminal follicles, which is what matters most);it could be overstimulated.

 

[Gone]

^ Yes Noisette, thank you for posting here