What About Samumed Phase II?

What is most significant and encouraging about this new data is the SM04554 treatment was applied for only 90 days, but continued to have positive results all the way until 135 days. The chart shows that during the 45 days after the treatment was stopped, there was still a continual increase in hair count from 110.5 to 115  in the 0.15% solution group. For the curious minds, it is possible that there was even more continual growth after 135 days, but that data was not presented by Samumed.

Figure 1
SM04554 Phase 2 Study - Hair Count and Density (ITT)

Are we there yet?

Samumed presented their phase 2 results at the American Academy of Dermatology meeting yesterday. I wasn’t there to see it, fortunately Samumed gave a sneak peek of their presentation to small audience through the Forbes magazine. The article on Forbes gives a very basic report on the statistics of the phase 2 study and a little bit of industry commentary for reader’s value. Here’s what the article said about growing hair:

The Goods

  • Most importantly, SM04554 grew hair.
  • The Phase 2 study group involved 300 people. The three groups received either a placebo, a 0.15% solution of SM04554, or a 0.25% solution of SM04554. In the placebo group, hair count dropped from 114 hairs per square centimeter to 111.5. In the 0.15% group, hair count increased from 104.9 to 115. In the 0.25% group, hair count increased from 110.8 to 118.5.
  • This roughly translates to a 10% overall increase in hair density from using SM04554, compared to not using it and continuing to lose hair.
  • One interesting facet about this drug is the results do not seem to increase when the amount of the SM04554 solution is increased. There is a certain point of the “just right” dose amount that triggers the most hair growth with SM04554.

The good news for Samumed is their topical solution grows hair. We can also look at the perspective that these results could become more significant when coupled with another topical treatment, like minoxidil. I bring that up because it’s almost certain that minoxidil and SM04554 work on two different mechanisms of action for hair growth and the combined results of the two treatments could be interesting.

Samumed has not speculated so far about the future of their clinical trial process with SM04554. They may have a little bit of tweaking to do now. The solution has shown to be safe and it grows hair. It’s a keeper. For now, we do have to call upon that ingredient that is oh so indispensable to hair seekers….patience.

15 Comments

  1. tom on March 7, 2016 at 3:45 pm

    I hope samumed presents pics and there plan/schedule in the near future. Thanks admin.



  2. Sam on March 9, 2016 at 12:24 am

    I can’t understand why people are so depressed?? 10% Increase in 3 months!? Are you kidding me that’s great and with no serious side effects or anything.. Cmon guys this treatment will help us win the battle.. We are closer than ever now stay positive. Just nervous to see this in phase lll hopefully it stays at these statistics



    • Follicle Thought on March 9, 2016 at 1:17 am

      I think you’ve got a good outlook on this Sam. The results are definitely positive and beneficial to hair seekers.



      • tom on March 10, 2016 at 5:01 pm

        Use along side histogen lookout mpb u are toast!!



      • Abhishek on December 15, 2020 at 12:40 am

        When did the phase 3 trail start and and



    • EducatingNoobs on October 7, 2018 at 10:34 pm

      It is definitely gonna be good. Esp. combined with wounding and a crth2 inhibitor. Sad thing though there is nothing for pge2 in the pipeline. They need to trial a 15-PGDH inhibitor or we have to use sulfasalazine…



  3. Bruck on April 2, 2016 at 3:14 am

    It appears that the Wnt pathway new potential medications can stimulate hair growth by about 10%. I think Replicel’s studies showed similar results (11%). This is good. Hopefully if the PGD2 inhibitor by Allergan can come to market this will even be better. And research is slowly being done to find the micro RNA links with hair loss. Research is moving fast but depending on new funding.
    We are all waiting and hoping….



  4. EL on December 29, 2020 at 1:24 am

    SM04554 and androgenic alopecia overall have been removed from the pipeline section of Samumed’s site. Thoughts?



  5. Hairloof on February 24, 2021 at 8:38 pm

    Admin, how do we know that SM04554 works on a different mechanism of action to Minoxidil?
    This study (https://pubmed.ncbi.nlm.nih.gov/21524889/) seems to suggest that Min also works by activating the Wnt/β-catenin pathway.



    • Follicle Thought on February 25, 2021 at 7:05 pm

      Minoxidil works most on VEGF production. It’s not a WNT activator by nature.



  6. Baldness on March 10, 2021 at 12:47 am

    Hy plz give me info
    1. Will Samumed’s product give us New hairs on complete bald areas?
    2. Will it increase hair density?
    3. When will be available?
    4. ahow much could its cost?



    • Follicle Thought on March 12, 2021 at 10:50 am

      Hi baldness,
      1. Possibly, but likely a modest amount.
      2. It is supposed to.
      3. Within a year in Turkey likely.
      4. Undislcosed.



  7. jose on August 23, 2021 at 2:04 pm

    if this product works … could samumed improve it? or is samumed working on an even more effective product



    • Follicle Thought on August 24, 2021 at 12:31 am

      It’s the same product, it has not been improved as far as I know.



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