Samumed to Initiate Phase 3 Clinical Trials

When it comes to a hair loss cure or groundbreaking new hair loss treatment, Samumed is one of the favorites to come out with something significant in the next several years. I have covered Samumed and its SM04554 hair loss product numerous times on this blog in the past. The product works via the activation of the Wnt signaling pathway and subsequent epithelial β-catenin signaling.

The company’s CEO Dr. Osman Kibar has been widely covered in the media, including a cover appearance on Forbes magazine in 2016. They also got publicity in 2018 in Business Insider after announcing plans to go public in 3-4 years.

Earlier today, reader “chris2” pointed out that Samumed is starting its final Phase 3 clinical trial for its SM04554 product. This news is provided in Samumed’s latest monthly newsletter (subscribe here). The best part of this story is that these trials will entail 625 patients, which is incredible. I do not remember hair loss companies ever testing their product on so many people in clinical trials. More often than not, they test on less than 50 human volunteers.

It is not surprising that Samumed can go all out with these trials. They have been valued at a massive $12 billion, and earlier this month, they received $438 million in new equity funding.

So in just this summer of 2018, we have received highly favorable news from: Samumed, CassiopeiaHistogen, RiverTown, Follicum, Organ Technologies/RIKEN/Tsuji. I hope Follica and Shiseido are next in line.

38 thoughts on “Samumed to Initiate Phase 3 Clinical Trials”

  1. 1) I remembered that they said they will conduct another phase 2, has it been done or did they cancel it ? If they have done a third phase 2, has the results been published ?
    2) Did they mention how long will phase 3 last ?
    3) Per FDA regulation, phase 3 must consist of 1000+ patient, they only have 600+ patients, is it legit ?

  2. Very interesting, but if it worked what does the product actually promise? Do they claim it to be a total reversal of hair loss, or just a cheaper/less invasive way of maintaining existing hair only?

  3. A Phase 3 is great news. I have never seen any Before and After photos hope it is something that will provide meaningful results. 625 test subjects is Great.

    Let’s just get any product for sale that really works.

  4. Let’s remember to *Reality Check* Phase 2 Results: Participants in the .15% group grew 11 hairs (104.4 to 115) and the .25% grew 8 (110.8 to 118). Compare that to a study of 5% Minoxidil foam that grew 24 hairs per cm2. So…

    —Samumed 11 hairs per cm2 (after 135 days)
    —Minoxidil Foam 24 hairs per cm2 (Week 24)

    TLDR: Our quest for a superior alternative to the Big3™ continues.

    1. I get what you’re saying. 11 per sq cm may not seem like much. However, we don’t know where this result was obtained. Minoxidil is only effective in certain areas of the scalp. If this is more systemic, and can be combined with minoxidil, we are looking at a significant improvement in what we currently have related to hair loss. I for one, am excited and will try this if/when it comes out.

      1. And those hairs that were obtained were not studied for their “follicle functionality” which I assume means whether or not they stuck around long enough to make much of a difference in the long run. But hey, as a minoxidil non-responder, I will try it—I’ll try anything in the pipeline that passes the FDA—but unless they improved their formula, delivery method, or unlocked the great secret, by their own words: SM04554 appears to be safe, well-tolerated, and *potentially* efficacious… In the .15% group, 75% of subjects reported slowing of hair loss, 37% reported hair growth… Not quite the cure we’ve been looking for or the odds I’d pin my hopes on.

      2. I seem to remember that Phase 2 results were only followed for 60 or 90 days after the treatment ceased. We all know that the hair growth cycle takes longer than that, possibly better results will be had with time. In addition, the potential treatment will be optimized in Phase 3, if it hasn’t been already. Samumed is a well respected biotech in San Diego, where I reside. I highly doubt these guys would bring something along to Phase 3 if they thought they’d simply have an mediocre treatment. However, this is a “Guy” on these forums who I’ve questioned if he was from the future as he predicts winners and losers. That “Guy” has crapped all over Samumed so we might as well throw in the towel on this one…that was sarcasm! :-)

    2. @Toccata: Minoxidil and Finasteride are obsolete. Accept it. 24 weeks are more than 100 days…And are different pathways to attack hair loss.

    1. I think we are still waiting for the phase 3 results or have they been published in the meantime? The last word was that the product release will be in 2019 (if phase 3 was successful). Could be a good bridge treatment until more stuff gets out in the following years. I am optimistic.

        1. Correct. Could be 2020 as well – I have no info. I simply figuered that 1 year after phase 3 results would be a realistic time to market.

  5. @Frenchguy

    Page 5 says: “SM04554 *may* have promoted follicular neogenesis and therefore *may* be a *potential* treatment for AGA.” · “These results suggested that SM04554 *may* be the first treatment causing follicular neogenesis.” (aside from wounding induced follicular neogenesis i.e. RAIN). They’re not speaking on solid ground yet.

    I’ll call it a breakthrough when it makes it through all those FDA trials and regulations and comes to market—THAT’S a breakthrough in itself!

  6. Would people say to hold out on a transplant at this stage, if you think you could make it another couple of years with enough to get by?

  7. Nice link posted by FrenchGuy on the study results. If we have any medical researchers who know how to read the charts and statistics, I would be curious about your interpretation of the graphs because it would appear that terminal hair count may not actually be going up because they don’t appear to be comparing either .15% or .25% to baseline but to vehicle. Which would mean that the statistical significance is due more to the vehicle or untreated subjects going down in hair count rather than the treated subjects going up in hair count. Clearly, treated subjects appear to be maintaining at .15% just maybe not going up. However, the .15% treated subjects are on an upward slope so maybe more growth could be expected later on.

  8. Spray-on hair fibres show a visible difference to the naked eye. No microscopes or data chart experts necessary.
    If all this company’s results has is an increase of a fraction of a percentage, they don’t really have anything. You can get 2% extra thickness just using coconut oil.

  9. This positive news is appreciated in a slow news period, but it’d be nice if we had any indication of results beyond currently available treatments. I’m just stating the obvious as someone desperate for any viable improvement. Hopefully, we’ll hear some great news soon!

      1. I think we were just spoiled by the jak developments, where they showed pictures of cured AA patients and we thought they might announce an AGA result. In each article, I look for proof of effectiveness and the hope that something could be available very soon. If I don’t see those things for months, I call it slow news! Sorry for being so picky. Just had too many years of “five years from now”.

  10. What about Follica? Do you think they might have already begun their pivotal trial? The optimization trial should have ended.

    1. We are probably going to hear from them in a couple of weeks. I heard they might post info in a magazine that will come out.

    2. FYI I had posted over a month or so ago that Follica’s Pivotal trial appeared to be imminent because Puretech’s pipeline website chart changed from showing Phase 2 halfway complete to showing it fully complete. It also added Phase3/Pivotal and Filing to the time line along with some other minor changes. However, on further review, I don’t believe these changes are indicative of anything because Puretech appears to have similarly revised the pipeline charts for all of its companies. Still, we are now almost 8 months into the optimization trials, so you would think they are getting close to beginning the Pivotal trial, assuming the optimization trails met with some degree of success.

      1. Thanks. But the optimization trial is part of phase II and according to their pipeline phase II should be completed. So maybe they are already in phase III or they will soon. I would be very happy to know that they have already started. I think optimization does not take more than six months.

  11. Does this treatment help reverse miniaturized and miniaturizing follicles or is it just simply a growth stimulant ?
    I am asking because if it is just a growth stimulant like minoxidil, then we will keep shedding because DHT is still there and attack our sensitive follicles.

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