Samumed, SM04554, Wnt/Beta-Catenin

Samumed — SM04554

36 Comments

October 2014 has perhaps become the most eventful month ever in the hair loss world when it comes to important new developments. Unfortunately, my day job allows me only so much free time, and I am therefore often forced to delay writing posts on new developments by a few days, especially in busy months such as this one.

So that is the excuse behind my delay in writing about Samumed’s SM04554 product and its pending phase 2 US clinical trials.  That clinical trials page was updated several days ago, and the latest development is that these phase 2 trials will run from November 2014 to October 2015.  The company is enrolling 300 male volunteers between the ages of 18 and 55 in this trial, with a number of inclusion and exclusion criteria.  The trial will involve three group (two differing doses, one placebo), and volunteers will be recruited in 14 states spread across the US.  Some of the people supervising these trials are well known in the hair loss world (e.g., Dr. Wilma Bergfeld in Ohio).

What is Samumed’s SM04554?

Samumed is a company that is based in San Diego and is involved in developing small molecule drugs that selectively activate or inhibit Wnt pathways.  I have written a few posts on this blog related to Wnt (see here, here and here).  The whole concept of Wnt signaling pathways is extremely complicated and it is well worth checking out the wiki on it as well as Stanford University’s page on it.  They even have a Linkedin Wnt group where people can ask questions.  Most of the ongoing work regarding Wnt research is related to serious medical problems rather than cosmetic problems.

Samumed’s SM04554 topical solution is thankfully an exception to that rule, and is designed to counter androgenetic alopecia via activating a Wnt pathway.  The company already started initial trials in Australia in 2013 and might even have completed those.  In that Australian trial link, there are a list of contact names underneath and blog readers who are very keen to know more might want to contact some of those people to find out further details.

Funnily enough, earlier this month when I was searching for and updating readers on Histogen’s and Replicel’s presentations at the San Diego Conference of the Mesa, I totally missed that Sanumed was holding an investigative pre-phase 2 clinical trials meeting on its important SM04554 product from October 16-18….also in San Diego of course!

I will be interested to see how this trial works out.  And if successful, will Samumed (like Histogen and Replicel) think about doing further trials in Japan and/or licensing their SM04554 product to a Japanese company in order to speed up time to market?

Gail Naughton, Hair Stimulating Complex (HSC), Histogen

Histogen’s Update from the Stem Cell on the Mesa Conference

9 Comments

Histogen’s excellent presentation from the Stem Cell on the Mesa Conference is finally available online and I have embedded the youtube video at the end of this post (hair loss related presentation is just under 3 minutes long).  Thanks to “Noisette” for letting me know about this in one of the comments under the above linked post, as well as to “the X” for letting me know in the hair loss chat. Also see Histogen’s presentation from last year.

I am not surprised about Histogen’s decision to get their final clinical trial for its male pattern baldness product done in Japan in early 2015, especially after Shiseido (aka Replicel) announced their intention to start trials in Japan during the first half of 2015.  Since starting this blog, I have frequently discussed the high likelihood of hair loss cures becoming approved in heavily populous Asia before anywhere else in the world, but I always thought that experiments, trials and approvals would be spread across the region, especially in developing countries such as China, India and Thailand. It is truly a wonderful surprise to instead see developed technologically advanced Japan dominating this sphere.

Histogen’s Hair Stimulating Complex (HSC) product seems to be significantly better than Replicel’s product as far as increase in long-term terminal hair counts go, although it was not entirely clear to me whether Replicel’s results were based on using a very low dosage or not, and how much better the results would be with higher doses assuming safety was not compromised.  Histogen’s results indicate efficacy in all areas of the scalp as well as on people over the age of 40.

For the female readers of this blog, the below video also shows that this treatment works for women too!  Although Histogen’s clinical trials (in the US) for women’s hair loss are well behind the trials for men’s hair loss, I wonder if women will be able to access the men’s product (administered via injections) as soon as it is approved and comes out?

FYI — US and EU citizens do not need to get visas to travel to Japan…but maybe I am getting ahead of myself here:-)