by Kevin Rands | October 1, 2016 7:54 pm
Samumed has been a riddle, wrapped in a mystery, inside an enigma for nearly a decade. An intriguing story of a brilliant businessman (slash) mad scientist with a lot of powerful friends, and a track record of successful projects under his belt. Already worth $4 billion himself, Samumed’s CEO Osman Kibar heads up the highest-valued biotech company on the planet: a whopping $12 billion.
And they’re right here in HairLossTalk’s back yard: San Diego, CA.
After having familiarized myself with their company, and the long, strange story leading up to where they are today, I was on the verge of driving to their front door and saying a quick hello. But having already been directed to their media contact company (Brunswick Group) by email and receiving zero response from the San Diego team (despite my charming assertion that we could “do lunch” since I’m in the neighborhood), I decided not to risk any awkward encounters.
Needless to say, I’m still going to consider it. Maybe I’ll add Osman on Facebook first and tell him I like his dog.
The story of this company alone could fill pages, and at the risk of stealing Forbe’s thunder in doing just that, I’ll give you a summary and save you the time: Mr. Kibar has managed to create a product offering that has some extremely successful CEO’s quitting their jobs to join his team, and several high net-worth individuals dumping truckloads of money into his company. And a new hair loss treatment is part of their research.
The new move in biotech surrounding “curing aging” and regenerative medicine is exciting to say the least. It’s relevant that a company which apparently leads the pack has hair loss in its sights, alongside helping us live forever.
So exactly what are they doing and why do you care as an individual affected by hair loss?
Well, until just this past September 17th, at the “13th Medical Innovations Summit” for the Royal Society of Medicine (sounds important right?) the entire project had been mostly under wraps.
They had already completed a Phase 1 SM04554 trial for their hair loss product called SM04554. And then in March, the data for their Phase 2 SM04554 trial was presented to the American Academy of Dermatology in Washington, DC. It showed marginal success at maintaining and regrowing hair in people with androgenetic alopecia (that’s you, unless you have patchy hair loss).
But is marginal really marginal when it comes to maintaining hair? Hint: that’s exactly what Propecia does, with a nice batch of side effects that may or may not ever appear.
They presented photos of people’s heads and the hair counts before and after treatment. Those who used the 0.15% topical solution of SM04554 saw an increase in hair count of about 9.6%. Those who used more (a 0.25% solution) only saw a 6.9% increase. They focused on men with more advanced stages of baldness (Norwood 4 to 6), and the trial lasted only 90 days.
Those of you in the “cool crowd” of hair loss knowledge may recognize 90 days as an insufficient duration for any hair loss treatment. They did continue hair count data until day 135 but its still very short for a hair loss trial.
Some of the most well-known proven treatments take a minimum of 3-6 months to start showing results, and upwards of a full year before your follicles really find their groove and you like what you see in the mirror. In fact the first 90 days are typically the months where most people throw in the towel due to shedding.
Then again, you’ve got treatments like JAK3 Inhibitors for Alopecia Areata which pretty much cure the condition the day they’re first applied, and trial participants didn’t see full regrowth until the 16 week mark. I suppose if you want to use anything as your gold standard for exactly how long it takes in the *best* possible scenario, this would be it, and it still took 30 days longer than this Samumed trial.
Needless to say the stuffy, highly educated elite in hair research weren’t the least bit impressed with a 10% increase in hair counts, and some were even confused by the reduced effectiveness with the higher dose. So exactly why did that happen?
On September 17th, Samumed finally came forward with their business model. After having attained hundreds of millions in funding, and a valuation of nearly $12 billion, they decided to let the cat out of the bag.
CEO Osman Kibar explained in his presentation that they were seeing unbelievable results in countless disorders with one interesting technique: controlling Wnt signaling. And apparently Wnt can only be stimulated or suppressed into a “Goldilocks” zone. Do it too much and its effectiveness is reduced. Do it too little, and it wont work as well. This is exactly why the trials were helpful. Now they know that a 0.25% solution is less effective than a 0.15% solution.
Without getting too technical, here’s what that means: their overall goal is to restore the regeneration capabilities of tissues, bones, cartilage, etc., to those of a newborn baby. As we age, the ability for our systems to accomplish this become damaged, inefficient, or overefficient.
The result (according to Samumed) is the development of many diseases. Osteoarthritis, Scleroderma, Alzheimers, vision degradation, gray hair, wrinkles, and (also according to Samumed) even hair loss. “Wnt” is the thing which controls this regenerative process, and their treatments modulate Wnt to restore proper function. Where it lacks, they improve it. Where its damaged, they repair it. And where it’s overactive, they suppress it.
According to their data, its working quite well. In the presentation, they showed videos of intentionally paralyzed rats walking again after a single injection (and sufficient time for healing). Degenerative disks were replaced by growth of entirely new disks. Arthritic joints received an injection and regrew all the protective cartilage.
Scleroderma really hit home for me, as my mother recently passed away from this debilitating autoimmune condition which causes thickening of soft tissue. This would be an example of overactivity of Wnt and their treatment suppressed it, resulting in normalization of the tissue.
But what about hair loss? In the last 17 years of running this site I’ve never heard someone hypothesize that hair loss is due to a breakdown in regenerative function. And now you see exactly why those in the hair loss community are unsure whether SM04554 is going to perform at all.
Still, seeing increase in hair counts means something. It means that simply by correcting an element related to aging, they fixed an element of hair loss. Nobody claims to know exactly what causes hair loss. We assume its androgen and gene related. Propecia works because it blocks the formation of an androgen.
Unfortunately, I was a little disappointed to see nothing more than a couple stained slides showing some cells for the “hair loss” portion of the presentation (skip forward to 8:45). But this really means nothing, aside from the fact that my “hair nerd” status probably just isn’t awesome enough to understand what I’m looking at. Like most people, I want to see previously bald heads gloriously covered in Fabio-like manes.
But I don’t think Samumed is touting the hair loss treatment as their flagship offering in the first place. It was effective. That much they’ve proven, and they have indicated that they will continue to include it in their ongoing research.
So here’s the deal with Samumed’s SM04554. Lets entertain a cup-half-full approach and look at hair loss’s most famous treatment: Propecia. Most guys can expect to at least maintain hair count, or increase hair count with Propecia by the 1 year mark. Well guess what? According to the data, that’s what we can expect from Samumed’s new product. So is SM04554 a Propecia killer?
We need more data. Longer durations. And just for the fun of it, toss in some more people too.
The number of people who saw increased hair growth in the Propecia FDA trials was negligible. Yet nobody has any problem rattling off “Propecia” as the first line solution for anyone experiencing thinning hair. Propecia is without doubt the most widely used treatment for hair loss on the planet. Between 2004 and 2008, Merck Pharmaceuticals saw over $1.7 billion in Propecia sales, and yet all it will really do is help you keep your hair.
The safety profile of SM04554 is the takeaway here. There were almost no relevant adverse events reported from the trial aside from skin irritation. Now think about that for a minute. Complete maintenance of hair count, with an average 10% increase, and no side effects. While most people don’t see side effects on Propecia, those who do can sometimes report significant ones which adversely affect both their mood and sexuality.
If you were offered a treatment that could completely stop your hair loss, without any of the side effects that come with Propecia, would you take it?
We are living in an exciting time for hair research. The myriad of unique therapies which are in the Pipeline right now are bringing different benefits over existing treatments. Having something which might maintain and regrow a little hair without testicle pain, watery semen, and libido loss is huge. And imagine the results if you combined it with Rogaine or other treatments? If Samumed can deliver that, they’ll have something worthwhile to offer.
We are hot on the trail for more information on this and several other projects currently underway, so …
We encourage you to bookmark our Samumed SM04554 Project Page and keep an eye on the list of articles near the bottom for ongoing updates. Better yet, please make sure you are subscribed to our Hair Loss News newsletter, which goes out only once every 2 weeks. You can also customize your preferences and get real-time updates on topics that are of interest to you.
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