Sm04554

[KO1]

Merck didn't make much money off fin.

[Swooping]

Means people could now buy generics, and none of that money goes to Merck. There is also no longer a brand name drug dominating the hair loss market, of which has only skimmed the surface. A new brand name drug that doesn't have sexual side effects and could potentially also used by women, would suck up most, if not all of the market. It would be a true slam-dunk in the pharma industry. Billions of dollars and untold potential.

Mwah, I think you heavily overvalue the market for androgenetic alopecia. For comparison the glaucoma market is almost twice as big. I won't even speak how big the market is for other segments but it's way way more than AGA.

Like KO1 stated finasteride financially wise was a pretty bummer for Merck too.

[Parsia]

Well I live in Dallas and the trial is in Austin. Theres always the possibility that I might get the placebo and I don't want to make the 3 hr drive each month for a placebo.

I am also afraid that if I get the actual CB, and it works to retain my hair, what happens after I stop the 6 month treatment? Would my hairloss continue at an accelerated rate? I still have enough hair to cover the thinning areas. I cant afford to have it fall out even faster after discontinuing CB.

Oh Really ? Is that In Austin ? I didn't know that , I live in Dallas too , I really interested to go and try it , if you want I can be your partner to go there every month and get the trail . Hope we don't get placebo . You can come with my car if you like to.

[It's2014ComeOnAlready]

Mwah, I think you heavily overvalue the market for androgenetic alopecia. For comparison the glaucoma market is almost twice as big. I won't even speak how big the market is for other segments but it's way way more than AGA.

Like KO1 stated finasteride financially wise was a pretty bummer for Merck too.

Yea, which is why I said finasteride only skimmed the surface of the hair loss market. If there were a drug with far less side effects, and can be used universally, it would be bigger than glaucoma. Nobody wants to be bald, or have their hair thin out. You are underestimating the market potential of a better drug than fin.

[It's2014ComeOnAlready]

Merck didn't make much money off fin.

Oh, KO1. Always there to try and correct me, but can't because he incorrectly reads my posts. If you look a little closer, I said fin skimmed the surface of the hair loss market. Also, Merck has made billions off of fin over the years btw. Maybe not every year, but billions no doubt.

[It's2014ComeOnAlready]

Clinical trial page has been updated again, is still recruiting patients in all 25 locations, and some are not yet recruiting. There are 4 months to go in this trial.

[champpy]

Parsia,
I don't know man, im still worried about what happens if we get the drug for 6 months then stop. But the offer is tempting. Ive tried to contact the clinic again to ask about this issue but I haven't heard back from them yet. Ill keep you posted as soon as I hear back from them

[KO1]

Oh, KO1. Always there to try and correct me, but can't because he incorrectly reads my posts. If you look a little closer, I said fin skimmed the surface of the hair loss market. Also, Merck has made billions off of fin over the years btw. Maybe not every year, but billions no doubt.

How much have they made?

[It's2014ComeOnAlready]

How much have they made?

You can look that up and get back to me. 1997-2013/14

[It's2014ComeOnAlready]

Good Find: That accidental "breakthrough" study that came out of Spain in December (some of you may recall) helps make the case for SM04554 all the more intriguing. Here it is: http://journals.plos.org/plosbiology...bio.1002002#s3

It's entitled: "Macrophages Contribute to the Cyclic Activation of Adult Hair Follicle Stem Cells"

Some good parts: "Our study delineates that macrophage-derived Wnts activate HF-SCs and HF entry into anagen...Determining whether these molecular signals are orchestrated along with the intrinsic HF-SC regulatory cues will be valuable to define the multiple hierarchies that underlie HF regeneration. Once powerful tools of molecular biology at hand in mice become applicable to human hair research, including novel in situ-imaging tools to assess HF-SC activation in humans, new translationally and therapeutically relevant insights into the macrophage-epithelial SC connection and its role in tissue remodeling, organ repair, and hair diseases may be achievable."

Let's hope they have the right compound/delivery to do what is intended.

[It's2014ComeOnAlready]

Just felt like posting something about the trials, in case people missed something.

They used 3 different formulations for their phase 1 testing: 0.05%, 0.15%, and 0.45%. Participants were required to use the medication for 14 days. Anagen entry takes 7-9 days. 14 days after use (28 days since start), all hair-related measurements etc were taken.

In the phase 2 study, they recruited 300 participants, the maximum allowed for phase 2. They're also only testing at 0.15% and 0.25%. 0.45% and 0.05% were dropped, presumably because they found the most effective/safest range. The good news is, that they most likely saw an effect, because they decided not only to go through with phase 2 studies, limited the concentration range for effectiveness and safety, but they also recruited the largest group possible, at the highest cost.

We all (hopefully) now know how crucial the WNT pathway is to hair follicle formulation and cycling, so if this drug enters phase 3, get VERY excited. If anyone has any qualms about this company, keep in mind they are experts in the WNT pathway, and drugs that effect the WNT pathway. They're also trailing drugs for more serious conditions like cancer and osteoarthritis that are also WNT related. Pfizer has various agreements with this company, and have their own people working with them in R&D.

[Keki]

The first product which goes to phase 3 is our next treatment, no doubt about that, i have a good feeling about CB and SM, we could replace propecia in a couple of years

[It's2014ComeOnAlready]

I wonder, if this drug makes it to phase 3, could they have a quicker trial than usual? The medication is only used for 90 days, and they have 300 previously recruited participants. Why not trial them altogether to quicken the process?

Hopefully SM makes it there. They just finished getting all their 300 recruits for phase 2, and have pushed the end of the trial another month to October.

[runrunrun]

I always read your article cafefully. Thanks 2014 Are they(SM, CB, BIM and Replicel)feasible?? I do not want to believe fake hope any more....

[It's2014ComeOnAlready]

I always read your article cafefully. Thanks 2014 Are they(SM, CB, BIM and Replicel)feasible?? I do not want to believe fake hope any more....

Hey runrunrun, they are all feasible in their own way, all different approaches, too. SM and CB are in phase 2, and we'll know in the fall if they'll proceed to phase 3. If they do, then they will almost certainly enter the market after. For those two different approaches, it should be about 2 more years till market because they will need to get through phase 3 (approx 1 year), and then FDA approval (approx 10 months).

Bimatoprost definitely works on hair, we just don't know the results of their last trial. Hopefully the results were good enough to have them move forward, but things have been very secretive since there are legal issues with other companies making the same drug. If they've continued trials, then we should see BIM sometime in late fall or winter. They haven't updated their clinical trial page to say if they're going with a phase 3, but like I said, they could be hiding the results and maybe their current testing. Hard to know for sure, but we should find out the results of phase 2b sometime during late summer. Keep your fingers crossed.

As for Replicel, this looks like a really good treatment, and Shiseido has thrown a lot of money and research into it. They have their own shiny, new facility in Japan dedicated to this alone. Because of Japan's fast track process, they expect this will be available in Japan by 2018. So, if you have a good amount of money saved up, you could fly to Japan and have this done.

There's also Kythera's Setipiprant, which should prove very effective. That's the PGD2 hypothesis driven by Dr. Cotsarelis from UPenn. That particular drug should become available in 3-4 years.

So, there are a lot of upcoming options and new effective treatments in the very near future. All of these have a lot of research behind them. No current hair loss drug was the result of research or science, they occurred by accident. Other angles have been figured out (WNT, PGD2, PGF2a, side effect-free topical anti-androgens, cellular replacement), and are now being trialled. Nothing will come tmr or a few months from now, but there should be a lot to smile about in the next few years.