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?