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