Category Archives: SM04554

Samumed’s John Hood & Sunil Kumar

So Samumed had yet another update two days ago. I was getting a bit annoyed and suspicious at seeing updates from the company every few days these past several weeks. Why can’t they provide all the information in one go if it has all been available for at least the past one month I presume?

It also seems like Samumed has only in the past month become active at providing press releases and sharing presentations on its website. Perhaps this is a sign that they could be sold in the coming year or are going to soon look for investors? All speculation on my part of course as I have negligible experience in the finance and investment arena.

Samumed Hair Loss Patents

In any event, I was 50/50 about covering this latest Samumed update in a whole blog post, but finally decided to go ahead after seeing something interesting. Samumed has 32 patents since 2010 according to Google Patent Search. Note that some of the same patents are listed more than once. Most of these patents involve Wnt/Beta-Catenin signaling related work, a crucial area of research in the hair loss world as well as in the broader medical world.

More specifically, a majority of Samumed’s patents involve work related to the Wnt pathway modulation via the use of Indazoles or something called 1H-pyrazolo[3,4-b]pyridine. I will leave it up to the chemistry expert blog readers on here to figure out further details behind these compounds and how they alter Wnt signaling.

John Hood and Sunil Kumar

It seems like a majority of Samumed’s patents involve two people:

  1. Dr. John Hood
  2. Dr. Sunil Kumar KC

Both these guys seem to quite accomplished scientists and have mild hair loss per their Linkedin photos here and here.

We have heard a lot about companies involved in finding a hair loss cure via PGD2 inhibition, PGE2 increase, wounding, hair cloning, hair multiplication, hair regeneration, dermal papilla cell manipulation, fat cell manipulation, newer anti-androgen development and more. Samumed seems to be the most likely company in the world at tackling hair loss via the Wnt/Beta-Catenin signaling pathway and therefore it is worth following the company even if it keeps releasing information in bits and pieces.

As far as the latest press release that I mentioned at the start of the post goes, the key sentence regarding Phase II clinical trials for the company’s SM04554 topical solution is that the product:

“Showed statistically significant increases for both objective outcome measures: non-vellus hair count (a primary outcome measures) and hair density (a secondary outcome measures), using the pre-specified statistical model.”

I am not overly excited about reading the above, as “statistically significant” could just mean yet another Minoxidil or Propecia (or even Bimatoprost — see Results) type treatment. However, with no evidence of significant side effects, SM04554 could be a great product if it enhances the effects of existing treatments. As opposed to different treatments cancelling each other’s benefits out and impacting the same hair positively, even if working via totally different mechanisms.

The most encouraging thing I read was that in in vivo animal models, SM04554 has shown to generate new hair follicles. This is a very rare outcome for any hair loss medication or treatment, as in most cases existing hair is made stronger and recently miniaturized hair is brought back to life. We are long overdue for hair growth success stories in animal models being replicated in homo sapiens.

Samumed — SM04554

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?