Sm04554

[rdawg]

Alot of positives to take from this guys, I think people are jumping to conclusions way too fast here, I'll break down why:
Here's the link to the official results release: https://www.samumed.com/files/2016/S...nal_3-1-16.pdf

1. This was a 90 day once-a-day trial, then 45 days of post-treatment assesment, meaning they used the drug for a very short period of time. After stopping treatment, the hair count continued to increase at month 4-5 (histogen claimed the same thing and after a year had a significant increase)

2. It shows clear efficacy on hair, and should really see how an increased dose affects the hair over the course of a year

3. We're guarenteed at least a phase IIb here, and I would hope they do once a day for an entire year and see how it is, as well as follow up with the previous group post-treatment after a year and see if they maintained, increased or lost in hair count.

4. The adverse events or side effects were very minor, mostly just tooth ache or muscle ache, nothing major as you can see in the slides above (and only about 5-10% of the subjects in the drug portion of the trial felt the affects).

very very promising stuff, clearly on to something with this drug, I think the hope has to be that it continues to work as more time passes(which appears to be the case).

hopefully they begin Phase IIb or Phase III right away.

[Hemo]

They already have a phase IIb going, it ends in April (they're also looking at scalp biopsies in IIb, as opposed to the measurements they took in the first phase II).

[allTheGoodNamesAreTaken]

results are published. they promise 10% in 3 months hahaha
another charade .. yo all remember the pitch from fin right? yes it was around 40% close to 50%... so it probably makes 1% affect in reality which would not be cosmetically viable anyways.
so what do you say guys? shall we ask admin to lock this thread...

I now believe we have talked about SM even more than the scientists working for SM
probably they werent even aware that so many people were waiting/talking otherwise they wouldnt have published such funny results

My non-biologist, non-Samumed employee opinion is worthless but I don't know why this is such a disaster. People are told to try propecia or minoxidil for at least six months or ideally a year before judging it, and even them just causing maintenance with no regrowth can often be considered a success. Hair grows slow and cycles slower. If someone posted on this site that they were noticing a few hairs sprouting after three months from either of those products, people would tell them it was promising progress. And who knows what this could be paired with. So yeah, these results won't blow anyone away but I disagree that they are a reason for full-on pessimism or writing this chemical off. It's one of only a very small number of molecules ever officially shown to grow ANY new hair, compared to a galaxy of failed attempts and useless, baseless snake-oils. So this is something. Not really investing much hope in it but the jury's still out if you ask me. Something safe for long term use that has protective effects on follicles even without regrowth and works on the majority of people would be a good, good thing to happen.

[mayapple]

they trialled it for three months - subjects grew NEW hair. They stopped - it continued to grow NEW hair, in a linear fashion. I don't know WHAT every one is so upset about already. IF the subjects in the trial CONTINUE to show increased hair counts in the next few months, then this is HUGE. It means that it is working months after application. Lets just wait and see.

[champpy]

I thought I read previously but they were restarting phase 2, so if they are not restarting then that's my fault, I'm sorry for rehashing bad info.

I guess there are some positives to take away from this but I think we were all expecting a little bit more. Does anybody remember or know if the molecules Follicum are working with are similar to SM?

[Thinning@30]

People keep citing this 40% growth figure from minoxidil. I'm not sure where that is from, but I think it's worth remembering that the concentration of OTC minoxodil is around 5%, while the SM04554 doses trialed were much lower. Furthermore, minoxidil doesn't work on everyone, and is known to have sides (heart palpitations, dark circles under the eyes, wrinkles). What's the point of having a little more hair if you still look way older than you are? Minoxidil did nothing for me anyway except make my hair look wet and greasy and smell boozy. And we all know how unflattering the wet look is on thinning hair.

Besides, who knows what SM 04554 might do for low Norwoods? Perhaps additional tinkering with dosage and vehicle will yield better results. There was so much hype about the novel mechanism of action with Samumed that I think a lot of us expected NW 6 -> NW 0 conversions or something from the trial, but in retrospect how realistic was that? Of course, I'm looking for reasons to stay positive here. I'll be a Norwood 50 billion by the time any new hair loss treatments come to market.

[rdawg]

They already have a phase IIb going, it ends in April (they're also looking at scalp biopsies in IIb, as opposed to the measurements they took in the first phase II).

Interesting, so it's likely that we see results from the full year wouldn't we very soon? This study started over a year ago i believe.

It's clear they like the direction of it, so we may actually get a full year update next month! Which would show definitively if this continues to work post-treatment.

[Haircure]

Alot of positives to take from this guys, I think people are jumping to conclusions way too fast here, I'll break down why:
Here's the link to the official results release: https://www.samumed.com/files/2016/S...nal_3-1-16.pdf

1. This was a 90 day once-a-day trial, then 45 days of post-treatment assesment, meaning they used the drug for a very short period of time. After stopping treatment, the hair count continued to increase at month 4-5 (histogen claimed the same thing and after a year had a significant increase)

2. It shows clear efficacy on hair, and should really see how an increased dose affects the hair over the course of a year

3. We're guarenteed at least a phase IIb here, and I would hope they do once a day for an entire year and see how it is, as well as follow up with the previous group post-treatment after a year and see if they maintained, increased or lost in hair count.

4. The adverse events or side effects were very minor, mostly just tooth ache or muscle ache, nothing major as you can see in the slides above (and only about 5-10% of the subjects in the drug portion of the trial felt the affects).

very very promising stuff, clearly on to something with this drug, I think the hope has to be that it continues to work as more time passes(which appears to be the case).

hopefully they begin Phase IIb or Phase III right away.

I think you interpreted the results incorrectly, the 0.15% solution had better results than the 0.25% solution, so a higher dose according to their results does not mean better efficacy. Also their results don't know the number of responders and non responders, so we don't know what it's % effectiveness is.

I get people want to see this in a positive light, but unless it has a high effectiveness rate for the results they posted and/or the results continue to improve over time, I think we can scratch this off as another failure compared to finasteride/RU/DUT/ and minox.

[beetee]

They already have a phase IIb going, it ends in April (they're also looking at scalp biopsies in IIb, as opposed to the measurements they took in the first phase II).

Thanks for sharing this. Can you let us know where this information comes from, preferably with a citation or a link? Thanks!

[Hemo]

Interesting, so it's likely that we see results from the full year wouldn't we very soon? This study started over a year ago i believe.

It's clear they like the direction of it, so we may actually get a full year update next month! Which would show definitively if this continues to work post-treatment.

No. The phase IIb is supplementary and includes different participants, not a continuation (as far as I'm aware). The initial Phase II already lasted a year - they decided participants would trial the drug for 90 days; that isn't how long the actual clinical trial was (people get recruited at different times, drop out, etc., so it's sort of like a revolving door that's open for 1 year).

[Seuxin]

So....we may be get new results after april ?

[beetee]

No. The phase IIb is supplementary and includes different participants, not a continuation (as far as I'm aware). The initial Phase II already lasted a year - they decided participants would trial the drug for 90 days; that isn't how long the actual clinical trial was (people get recruited at different times, drop out, etc., so it's sort of like a revolving door that's open for 1 year).

Can you please share the source for the ongoing IIb information?

[dutchguyhanging]

they trialled it for three months - subjects grew NEW hair. They stopped - it continued to grow NEW hair, in a linear fashion. I don't know WHAT every one is so upset about already. IF the subjects in the trial CONTINUE to show increased hair counts in the next few months, then this is HUGE. It means that it is working months after application. Lets just wait and see.

i see you are obviously newbie and dont even know the pitch from fin. I would strongly advise you to go back and check trial results of fin... i cant here explain numbers to you all.. so yes we are very frustrated and disappointed. case is closed for me. I am not waiting SM anymore

[Hemo]

Can you please share the source for the ongoing IIb information?

https://clinicaltrials.gov/ct2/show/NCT02503137?term=samumed&rank=3

it's also mentioned in some articles about them/on their website, but apparently it didn't occur to you to look anywhere.

[dutchguyhanging]

I think you interpreted the results incorrectly, the 0.15% solution had better results than the 0.25% solution, so a higher dose according to their results does not mean better efficacy. Also their results don't know the number of responders and non responders, so we don't know what it's % effectiveness is.

I get people want to see this in a positive light, but unless it has a high effectiveness rate for the results they posted and/or the results continue to improve over time, I think we can scratch this off as another failure compared to finasteride/RU/DUT/ and minox.

oh no of course they know the number of responders and non responders and also one year trademark results. It is just so disappointing that they dont want to publish more than necessary. if it was promising, they would be all over the news guys.
lets be realistic here for a minute ok? image u done the trials and u have seen all nw7 candidates became nw1 in 1 year period. first thing u would do is to call BBC, CNN all mainstream media like, and say that you have found the cure. and ask for financing and get shareholder attention. u dont need to work for the rest of your life once you get it to the market.

just think about it.. yes technology is patented so they dont worry about IP theft or something...