Category Archives: Wnt/Beta-Catenin

Samumed’s SM04554 is no Miracle Cure

Update: Samumed released their presentation files.  Actual presentation at the conference was by the CEO Yusuf Yazici.

Press Release.

Details.

Per page 12 of the above second link, while the treatment lasted for 90 days, the final hair counts were measured at day 135.  So in spite of no treatment for 45 days, hair counts still increased from day 90 to day 135.

Important finding:

“No serious adverse events (SAE) observed in the treatment groups, and the incidence of adverse events (AE) was similar between treatment and control groups.”

Also now covered in the Daily Mail and Business Insider.


I have covered Samumed and its SM04554 product numerous times on this blog in the past several years.  My first post on Samumed was written in 2014 and is worth a reread.  Last month, I wrote about the upcoming 74th Annual Meeting of the American Academy of Dermatology (AAD) between March 4 and March 8 — with Samumed taking center stage.  In that post, I stated that: “I am not expecting anything particularly impressive in this latest presentation, but would be more than happy to be wrong.

Unfortunately, I was not wrong (and I am very surprised that so many people expected this to be a miracle and are so depressed on the hair loss forums!).  Although Samumed has yet to release its presentation slides or pdfs from yesterday’s presentation for public viewing on their website’s media page or publications page,  a Forbes magazine article summarized their Phase II clinical trial findings.  The results, while good (a 10 percent increase in hair count after only 3 months of topical application), were nowhere near what one would deem as groundbreaking.  Note that all 302 patients that were treated were high Norwoods (4 to 6) on the Norwood-Hamilton balding classification scale.

Moreover, one strange development was that the lower (0.15 percent) dosage yielded better hair count growth than the higher (0.25 percent) dosage (9.6 percent growth versus 6.9 percent growth).  However, this does make the study more believable in my opinion.  It is also worth noting that SMO4555 is tackling baldness via targeting the Wnt pathway, which is something that is entirely different from what all other hair loss drugs and lotions to date have targeted.  It seems like the typical phenomenon of higher doses being more effective for hair growth may not apply when dealing with the Wnt pathway.  Or this could just be a one time anomaly.

One of the reasons that I was not expecting any miracle is because of Samumed’s 2013 Australian clinical trials not getting much coverage.  It seems like those results were never published?

For the time being, we can only hope that 6 month results will be superior to 3 month results.  If not, we at the very least have yet another weapon in the fight against hair loss.  After having just one topical product (Minoxidil) to tackle our hair loss problems for the past few decades, we could soon have four or five separately acting topicals as I mentioned in this post.  In the words of a great sage named “Farhan”:

“I will put all the topicals in blender..may be add a bit of lavender for flavour…mix it and I will apply it on my head…”

Finally, we should also remember that the science behind SM04554 is sound and their team is led by two scientists who have been involved in hair loss research for years The Forbes magazine article I mentioned earlier states that Samumed is a  “largely unknown biotechnology company.”  However, this unknown and fairly new company seems to have the resources to hire esteemed hair loss research scientists, including others besides the above two that are conducting the trials at centers around the US.

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.