Samumed E-mail

Someone associated with Samumed just e-mailed me today (see blue text below for contents) and I was pleasantly surprised since I have not contacted the company anytime recently. The e-mail pertains to their SM04554 topical product to treat male pattern hair loss. Please list your questions for Dr. Yusuf Yazici in the comments, but do not be disappointed if he never responds. Even though they have offered us the opportunity per the last sentence of the below e-mail, I have doubts that I will get any response. Any profanity or sarcasm laced comments will be deleted and/or ignored.

E-mail:

Subject: Samumed presented data on increases in hair follicles observed in its Phase 2 biopsy study for a potential treatment of androgenetic alopecia (AGA) at annual meeting of the American Academy of Dermatology (AAD)

Hi,

I wanted to share a brief update about Samumed, which presented the results to its phase 2 biopsy study on a potential treatment for androgenetic alopecia at the annual meeting of the American Academy of Dermatology.

Specifically, the study revealed three compelling findings:

  • There were statistically significantly higher total follicle counts compared to the vehicle.
  • Samumed’s treatment may be the first leading to follicular neogenesis.
  • There were no serious adverse events reported.

The full release can be viewed on Samumed’s website HERE and I’ve also copied the text below.

Please let me know if you’d like to speak with Samumed’s Chief Medical Officer, Yusuf Yazici, and I’d be happy to connect you.

Best,

Mr. XYZ

103 thoughts on “Samumed E-mail”

  1. “Potential treatment, statistically significant.”
    Yawn… show me the pics tell me when I’ll show you the money.

    1. Egghead, I deleted your last comment because it was in all caps. Please repost, and avoid any sarcasm or insults since Samumed employees will read the comments here. Just directly point out what you want from them.

      1. So much for reposting without sarcasm.

        Any chance this will be propylene glycol-free? Using Rogaine with PPG is what ruined my hairline in the first place and sort of sent my life on a downward spiral lol.

    2. Typically when the pics come in everything is “photoshopped… bad lighting… stock photo…” I’m more pleased with this generic email to be honest, they aren’t trying to dupe us right off the bat. I’m pleased enough.

    3. This is a biopsy test. It’s on a 4mm plug of skin. If they had full head Hair Club For Men style photos you’d say they’re fake anyway.

  2. Huge !
    Thanks Admin for sharing this opportunity.
    Maybe we could ask when do they plan to start phase 3 ?
    And some details about the trials they plan to do in phase 3 like
    how many subjects and how long ?

    Thanks again for your work.

  3. The press release only states that the increase in hair was statistically significant. It doesn’t say anything about the percentage change in hair. This press release could be describing a trial in which guys went from nw6 to nw1 or it could be describing a trial in which everyone sprouted 2 more hairs per sq inch.

    I would ask for some clarification on the efficacy of the treatment.

  4. @admin, a few of the “usual”

    Question – does the treatment turn dying vellus hair back into terminal hairs?

    Question – Since they tested on higher norwoods im curious to know if the treatment could possibly grow hair on bald spots?

  5. Hopefully he answers back soon. When do you plan on emailing him?

    Some questions…
    1. How much regrowth or new growth do they expect to achieve?
    2. Some clarification to the last trial results. The new data released doesn’t seem to be “statistically significant.”
    3. When will they start phase 3?
    4. When do they think the product will hit the market?
    5. What will be the product’s treatment protocol? (Daily topical application or some other method?)

  6. After reviewing the hair count data that’s included in the poster presentation on Samumed’s site, I’m inclined to say that this treatment looks pretty dire. There was zero regrowth, only a slowing of loss (by contrast, histogen’s trials showed a +70% increase in hair count).

    Putting the side effects issue aside, I’d be very curious to know how they expect the treatment to stack up, efficacy-wise, against fin and minoxidil, as well as against prospective future competing treatments, and what the basis for those expectations is.

    1. Sorry, that figure should be +39% increase for the histogen-treated men over 40 (as opposed to the zero increase for samumed-treated men)

    2. How can there be “zero regrowth” if they’re creating new follicles? It’s not like they’re creating dead empty follicles.

      1. The paper is a little tricky about this. It reports ‘significantly higher follicle’ counts than vehicle, but that’s because the vehicle-treated group declines while the treated group holds steady. It also says that there is a higher level of a certain protein associated with the creation of new follicles (or more specifically, with certain types of hair cells). There may not necessarily be new follicles; alternatively, the medication could be working by constantly creating new follicles while old ones continue to succumb to MPB.

  7. Hey guys. I know ti isn’t relevant but posting here is how ill get feedback. I am 23 been balding since 17/18 I used minoxidil got fantastic results but stopped over a year ago due to constant palpitations etc. I at the moment have a bad crown, and frontal loss. Its really bad for my age. I wanted to know as I’m first considering it, is propecia really as detrimental as they say to the sex drive and everything in terms to sexual aspects. Or is it just over exaggerated crap. Recently never even wanted to try propecia but the bald truth podcast got me thinking why not try. Any feedback would be appreciated 🙂

    1. I’m sure everyone reacts a lil different. But I’ve experienced absolutely no loss of libido whatsoever. The only sides I had were a slight brain fog at times and watery u know what. Both of which disappeared within the first few months. 33 now and I wussed out on it at your age.. wish I hadn’t. Would have had a damn near full head of hair if I’d jumped on it. I’d say give it a go for 3-4 months and see how it goes. Cue the usual fear mongering comments…

    2. I think it depends on your body fat percentage (due to downstream effects of the drug) low body fat= sides less likely imo. I had increased energy when i started taking it. Saw regrowth in temples.

    3. Jason stathom

      Most people’s bodies will be able to tolerate the adverse affects to the body and won’t experience major side effects.

      DHT is an important hormone but reducing it by approx 60%-70% seems to be tolerable for most people. In addition, estrogen increases with finasterise because DHT prevents testosterone from converting to estrogen. But as I said, most people tolerate it.

      I personally have used finasterise for a few years but gave up. Couldn’t tolerate the side effects anymore. Fortunately I recovered 100%, but my hair has been thinning ever since. Now I just buzz it and move on with life. Although it be nice to see new treatments to get it back. I’d say give it a try.

  8. Jason Statham..I’ve been on Propecia for over 10 years. It works and dramatically stopped my hair from thinning during my 20s and early 30s. Some minor sides but they went away after a couple years. I don’t regret taking it. Best decision I ever did. If you want to keep your hair hop on 1mg daily and never look back buddy. Buy a good hair vitamin and add Rogaine. You should be good to go.

    1. Same here. Start loosing good hair at 18 yo, but got balls to take drugs Is 21. Regret only about 3 years of losing hair, if I have timemashine – will take drug as fast as I can, not loose 3 years. Now I hade average hair, 3 years ago I have 10/10 hair.

  9. Samumed Question.

    1) It seems the topical is effective at increasing vellus follicular units. Do you expect the increase to keep ocurring past the trial results? Have you seen this occur in animal studies?

    2) Do you have data as to why the lower dosage works better in some cases?

    3) Did you observe any created vellus hair turn into terminal hair?

  10. Q for samumed:

    Many hair loss sufferers are interpreting the phase 2 data as SM04554 being an ineffective cure for MPB but a possible new treatment to prevent further loss with some regrowth, similar to or perhaps slightly better than minoxidil. Would you consider this a fair interpretation or would you be expecting more efficacy in further studies? Thank you.

  11. some of you guys writing bs,
    i dont wanna be optimist or pessimist but the thing is, the companies knows the 3 products we have on the market to treat hairloss ( Fin, Minox, Keto ) (there is others but not FDA approved) so, if they are in the game is to achieve a better treatment than the current ones, so stop saying baseless objetions, we gotta be patience and we’ll prove how the new treatments works, meanwhile the best option if you guys are desperate it’s get a good FUE HT surgeon and wait without worries 2 or 3 more years till the a new product hit the market, that’s what im going to do, im sick of waiting for a new treatment.. since 2010 hearing every single year the same ‘” a new breakthrough in early 2013, 2014, 2015… etc ‘”

    Patience guys, we’ll arrive.

  12. Hi Admin

    Questions: Are they planing another phase 2 trial concerning the dose? Or do they think the optimald doses are 0.15% /0.25% or inbetween that range?

    In general: Whats the next step? What about a timeline?

    Tahkns.

  13. i agree. I did statistics before….. statistically significant means the results are indeed better. but we dont know if it is 1% or 99% increase in hair count.
    it will just tell you that your results are not just random based on the dataset you have.
    but I would appreciate if he can share more data

  14. Something to perhaps think about is that the topical is not stopping hair loss. It is perhaps creating hair while other hairs are falling which could make it seem like it is just mostly mantaining terminal hair. Combining with finasteride could really boost results potentially.

  15. A cocktail of treatments such as PRP + A CELL + Samumed + Histogen could work as a non surgical solution. These coupled with gene snipping could work as a viable long term cure.

  16. Three questions:
    1. when (most pessimistic date)?
    2. where (japan and…)?
    3. what are the theoretical risks such as signaling awakening other kind of cells such as bone etc?

  17. My questions:

    1. Did Samumed notice difference in response between different regions on the scalp? E.g. does it work better on the vertex?

    2. Do they foresee difference in response based on how long is a hair “lost”? In other words, would Samumed help on areas that have been bald for a long time?

        1. That’s their speculation based on observations of an increased amount of protein expression.

          Even if it is occurring, the data showed no increase in hair count, so it doesn’t look promising for advanced norwoods.

          1. Look at the vellus follicular units. They do seem to have increased in number. The key thing would be to then turn them into terminal hairs perhaps with a diff treatment for a small minoxidil-like result except perhaps longer lasting. Limited results but they are there. There are probably doing a second phase 2

  18. So, if I understand the Samumed numbers correct this treatment will stop further hair loss but not grow any new hairs? Regrowth would be great but a new treatment that stops (or slows down) further loss would also be awesome and ofcourse something they would make billions on.

  19. Histogen KO, Brotzu KO, kelopecia KO, Samumed KO Next follica and Next year maybe Replicel…. And the situation worst every data!

    1. Histogen is probably the best bet. They’ve obtained fresh tranches of funding, they’re moving ahead with trials, and they’re relatively open about their data and progress compared to other companies.

      Replicel’s fate almost entirely depends on whether Shisheido is satisfied with their trial results.

      Samumed seems like the most likely to be one of the many small-cap biotech companies that just exist to pay their execs salaries with investor money (especially since all the stories about them emphasize the charisma and star power of their founder, rather than the scientific fundamentals).

  20. Research from Bonn, Germany

    https://medicalxpress.com/news/2017-03-genetic-links-baldness.html

    “Several studies indicate that losing one’s hair early in life is also associated with serious health conditions including prostate cancer and Parkinson’s disease, so understanding how and why men go bald, could enhance understanding of a wide range of other conditions, according to researchers.

    The variants found in this study were in or near genes that play a role in hormonal status – melatonin signaling, fat cell differentiation, and the growth phases of hair. Six of the genetic variants identified are on the X-chromosome and may account for some of the similarities in hair loss between men and their grandfathers on their maternal side. The remaining variants are on the autosomes, the non-sex chromosomes.”

  21. The best thing for us to do about SM is to wait and see what they say at the upcoming conference in April. We may be reading the data wrong. Maybe it’s measuring new follicle formation and not regrowth of dormant hairs shut down by dht. If that is the case then this could be good. Stopping of further loss, thickening of existing hair and 10% growth of dormant hair and then their little neogenisis.

      1. That is why I particularly don’t like the part in Netshed’s article that said “Researchers believe that the identified genes could be promising targets for drugs to treat the condition”. Anything can happen but I personally do not believe any drug is going to be able to fix this without having some type of domino effect rearing it’s head later on.

  22. Admin:
    I just saw this site online & read your intro. Do you still believe it’ll be cured by 2020? Seems that it isn’t very likely considering we’re looking at potential new treatments by then?

  23. It is really sad that there won´t be anything out the next time, maybe years. A lot of big disappointments the within last months 🙁

  24. @ms, the Brotzu lotion could be out in about a year. Its a bummer that Fidia did not release it early this year, like ppl speculated they would. But they released a statement confirming that they a still working on the product, which is very positive.

    1. Yes sure, but still not sure if we should trust in fidia. A lot of strange things happend, they only mentioned AA first in their statement etc. And why Brotzu claimed in the beginning that it could already be out half of 2016, he should know better about how long it takes to get a product introduced to market or? It would have been super fast, that´s a main reason why people got so hyped and now very disappointed but his claims were quiet unrealistic from the beginning. He should know better…

      1. If it brang back 5 years worth of hair like people were claiming first I’d be psyched but I’ve heard otherwise since then.

      2. @ms The disappointment around Fidia’s lotion is based on complete misinformation and false hype that was created by many desperate people simply reading into small things and then taking them as fact.

        With the way people view Fidia now, you would think they released horrible results or said that the lotion won’t be coming out for ‘5-10’ years. None of this is the case. Besides a ‘delay’ (even though it is not a delay because Fidia never announced a release date prior to their press release), nothing has changed for this lotion since everyone was all hyped about it back in the summer.

        The mentioning of AA in the initial English press release was simply a result of bad translation. The original Italian (Fidia is an Italian company, and the woman who released the statement was a native Italian speaker) mentioned all kinds of Alopecia. This is why the English press release was edited only an hour after its original publication.

        Brotzu claimed that the lotion could be out in 2016 back when he was working on it by himself prior to 2015. This was before Fidia bought the patent for the lotion. He could not have possible known back then how long Fidia would take to develop it. When Fidia announced that the lotion wouldn’t be out until 2018, even Brotzu said that he was surprised it was taking so long.

        It’s likely that the delay is a result of stability issues (I.e. that the lotion loses its effectiveness over time). This makes the storage and shipping of the lotion hard. They need to change the ingredient in order to make the lotion more stable over time.

        They predict that the final form of the lotion should be complete by 2018. It should be brought to market some time next year based on this.

          1. I remember seeing on some Italian blog that someone was making his own Brotzu lotion. This was a few months ago. I wonder how that went.

        1. Thanks for your explanation. I hope you are right and the results are as good as they claimed initially. In my opinion it is the closest treatment right now because I think follica will be out later than some of us exptected before the presentation in Orlando a week ago. And for EU citizens even later…..

  25. Gho is a scam and joke in the hair multiplication industry. I’ve been following him since the year 2000. His HT work is horrible. I actually mentioned Gho when I first started losing my hair to a dermatologist. The derma laughed and said ” ahhh the famous Gho lol” . She was right.

    1. Well guys.. I’m now signed into biomedical/genomic engineering this fall while working 911, it will be fall 2020 iF I pull through. I’m going to dedicate my life to hacking congenital diseases.

  26. guys, i also checked this with my scientist colleagues. I dont think you can cure baldness with medicine, pills or droplet so on. it has to be on molecular level.
    @admin: do you know anything about this? baldness is not cause of one problem, there are many factors affecting and ageing seems to be one of them.

    I think we have to be realistic here and accept that only hair multiplication can save us.
    and guys also we are not all balding same right? some from crown some reverse.. so its like cancer, you can treat lung cancer with blood right?
    i think we are far toooo away from the cure when you consider my sayings. just think about? we ALL have hairs when we are 10 or 15 (yes 99.99% guys have full hair)- ageing also affects

    1. I actually agree with you. I don’t think anyone here thinks that some topical or pill is going to tell Mpb whats up and poof hair like before or hopefully not. I think most of the people hoping for these types of treatments are more on the lines of stopping the progression then actually reversing it. These people are the ones who’ve had bad experiences with the current drugs and are low Norwoods I believe. While aging is a cause of hair loss (most if not all women and men without a trace of mpb experiencing some loss in density after their 50s) I don’t think we can say mpb is from aging unless some of these teenagers getting mpb early have some form of progeria. I believe puberty and the change in the gene expression play a crucial part here. Why in a specific Norwood pattern is the mystery to me. I would assume all of the hair should be dht sensitive if this specific pattern is but they are like the crop circles of our head. Anyone who is a nw3 and on i would suggest focusing your attention more towards companies like Tissuse, Hairclone, and Sanford maybe donate a little doesn’t have to be a lot just what you can spare when you can. That way at least you feel like your in the game and a part of the solution and it should hopefully give you the sense of being proactive about this whole ordeal instead of checking these blogs and getting disappointed the cure is not suddenly out and being shipped to you via prime already. I know it sucks I get disappointed too but I’d rather contribute, try, and lose then sit idly by and watch the teams I’m rooting for lose. At least if you donate or try to help some of these companies in some way even if its small THEN you have room to get all disappointed and pissed when they don’t turn out. Ive currently been looking into this whole crowdfunding deal and trying to see how maybe I could get something started around my area maybe it won’t turn out but it feels alot better knowing I’m trying to make a path forward maybe that would work for some of you also? Perhaps some of you are already doing the things I’ve suggested and thats awesome. This is all just my opinion.

  27. Guys first of all a treatment to be a cure; we should always use it and it should contain of 2 compounds:
    1- compound that awakens the dormant hair follicles to start the hair cycle.
    2- compound that avoid the awaken follicles from baldness factors threatenings that are still in our scalp

    1. baldness factors? = that is what I am referring to.. that we still dont know. and just by looking at the complexity, it looks same as achieving immortality.
      there is only way one which is hair multiplication.
      no magic pills can get your full head of hair. that road is too deep and complex. like i said we dont still know why we have different types of hairloss patterns? probably each one has different treatment.. so each one should have different name instead of calling MPB….

      on top of all, the complexity is so deep into your DNA basically you can not cure it with significant sides.
      i would ask all of you just to step back and read what i am saying.

    1. You mean the part where Dr. King states that tofacitinib does not improve MPB? Yeah everyone knows that. He’s talking about taking it orally. Topical shows promise.

  28. http://www.businesswire.com/news/home/20170306005410/en/Samumed-Presented-Data-Increases-Hair-Follicles-Observed

    Explains the Samumed results a little more.

    “Follicle count data from observations at the tissue level in this biopsy study, together with non-vellus hair count increases we observed in past studies, are very exciting for the future prospects of SM04554 as a potential hair regeneration drug,” said Yusuf Yazici, M.D., Chief Medical Officer of Samumed.

  29. Cots said in the past that jak won’t cure mpb. Then aclaris states that it does work. So my gut tells me to trust cots since aclaris is a pharmaceutical company looking to make big bucks but then again cots has a treatment he is trying to sell so he would definitely downplay any competitors. I hate this indusyrt. I feel like aids is easier to cure than mpb. Ughggh. Or maybe the new world order purposely wants bald people to walk the earth hahaha

  30. i’ve been thinking all night and i got the answer, why we dont have a new treatment or a cure por mpb in 2017? Easy, because our governments want bald people to look similar to the aliens and dont scare them if they come for a visit.
    Has you ever seen an alien with a full head of hair? it’s all about evolution guys, we gotta accept it.

  31. Hello Admin,

    Thank you very much for running this site. I am wondering if there is anyway that you could get in touch with Histogen people to find out if they have any updates?

    Thanks much!

  32. Does anyone know if Follica has completed their 1st clinical trial on humans? I am assuming that “pivotal means this will be there third and final trial prior to commercialization of a product. I wonder why they have no data released on the other trials?

  33. it is not depressing. its reality.
    please if u have time, have run through this document or just this sentence below.
    it says 313 AD??? guys dont be ridiculous, mankind is desperate to solve baldness. I am sure people did almost everything tropical to cure for centuries long… just take a step back and try to understand how hard to solve baldness. if we see the cure in our time, I think we would be very very very lucky. luckier than winning powerball…. seriously 313AD?? what are our chances to see the cure? just think about it..

    When Christianity became legal religion in Rome in 313 AD, Church started criticizing wearing of the wigs and declared it a greater sin than adultery

    http://www.historyofhats.net/wigs-history/history-of-wigs/

  34. @admin: what happens with new treatments for MPB? Minoxidil and finasteride don’t work! What happens with terminal hair?

  35. @donitello what do you mean by cure are you talking anything that can bring back a full head of hair or medications? please elaborate. Things certainly look different now from when they did in 313 A.D.

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