Aclaris Therapeutics Countdown Begins

As usual my plans to avoid talking about Aclaris for several months went down the tubes yet again (always a good thing). For those who are new to this blog, you can go to the “Categories” menu and select the “Aclaris Therapeutics” choice to read all my prior posts about the company. It is developing a unique topical JAK inhibitor product to treat androgenetic alopecia, the most common type of hair loss.

Aclaris Therapeutics Phase II Trials Commencing

Yesterday, blog reader “Champpy” made a highly interesting lengthy comment about the soon to start Aclaris Therapeutics Phase 2 clinical trials for their topical JAK inhibitor product named ATI-50002 (for treating male pattern hair loss). He was approached by a research company that is recruiting volunteers for the trials. The most important part of his comment was that they are especially interested in patients who are at least Norwood 3, 4, and 5 on the receding hairline scale. This caught my eye, because the implication is that the company expects ATI-50002 (if effective) to regrow hair even on entirely balding regions of the scalp.

Moreover, Aclaris also updated its clinical trials page yesterday with far more details (h/t “Tocatta”). While they mention that they are looking for 24 male and female participants, the research company that approached “Champpy” said that there was major interest from people interested in volunteering. I wonder if they can change their minds and recruit more than 24 people? Or maybe they are recruiting 24 people in each location that they mention on there (Colorado, Oregon and Texas) for a total of 72? The trials are expected to be completed at the end of October 2018.

Having mentioned all the above encouraging and speedy developments, it is still a good idea to keep things in perspective:

  1. There is a possibility that this topical JAK inhibitor treatment can cause serious side effects, including cancer. At the moment, this possibility looks to be rare to nonexistent, but it is too soon to tell for sure. Of course at the slightest sign of cancers or tumor growth, clinical trials will likely be disbanded immediately by the US FDA.
  2. Even on alopecia areata patients who often see tremendous hair regrowth with oral JAK inhibitors (e.g., see here and here), success rates have not been universal. Some patients see no regrowth at all, although at least half seem to get great results. So even if this treatment does end up working on those with androgenetic alopecia, it is likely that some people will never see any benefits.

I have mentioned this a number of times, but it is worth repeating: Aclaris is the first ever company involved in the search for a hair loss cure that has moved along faster than expected. In all other cases that I can remember from the past, companies involved in this sector have moved along far slower than expected, with numerous delays in trials and funding. Oftentimes, these companies have decided not to proceed with final stage clinical trials; or have sold rights to other companies; or have decided not to bring a product to the market even if it is somewhat effective at regrowing hair.

Hopefully Aclaris keeps surprising us and goes All The Way in this year of Shohei Ohtani.

Also, in March and April 2018, Aclaris CEO Neal Walker purchased almost 20,000 of his company’s shares.

47 thoughts on “Aclaris Therapeutics Countdown Begins”

  1. While i think it may be a good sign that they are testing higher norwoods, it also just may be easier to see regrowth on people with advanced hair loss than it would be on a person w slight diffuse loss. But either way they are chugging along rather quickly. Thanks for the shout out, admin ;)

  2. “Hopefully Aclaris keeps surprising us and goes All The Way in this year of Shohei Ohtani.” haha. or it might be a sign that the cure will be coming from Japan! Either way I’ll be praying to the Angels.

  3. Do you think they’ll let me participate in the trials? I have a norwood 2 hairline with massive diffuse thinning/miniaturized hairs. I have hair everywhere on my head, its just thinned out, to the point I buzz it to a 1 grade(If I grew it out, you can see through my scalp).

  4. While I always hope for the best I can’t say i see anything that would cause excess optimism.

    1. “Norwood” level is irrelevant. All that really matters is how much hair is present in the given region that is being used for statistical analysis. For example, Samumed used “higher norwoods” but they still had tons of hair in the region on the crown that was being studied. This is an age old common trick. That’s why finasteride, minoxidil etc only took data from a spot in crown that already had a ton of hair. PRP, microneedling etc are the same. It’s far easier to grow hair where there is already tons of hair than to grow any hair in a region that is extensively thin. Samumed’s hair counts were already over 100+ hairs per cm2 before treatment! You could classify a young guy with tons of hair as a “NW6” simply based on his pattern.

    2. Plenty of companies start fast initially but stall when it becomes obvious they can’t greatly exceed current technologies. Again, to use Samumed as an example, they immediately went from a phase 1 to phase 2 and a phase 2b and then at the start of 2016 stated that they planned to move to a phase 3. Of course, they then released data from their phase 2 that showed weak results and now as of 2018 their current position is that they plan on doing another phase 2 at some point. That’s quite a change from what they said “nature biotechnology Feb 2016” when they stated they were planning to move to a phase 3!
    But, as usual they had the same problem everyone else has. Weak results that grow small amounts of hair in regions that already have tons of hair.

    I’m going to hope for the best but I’m skeptical. I don’t see the works/doesn’t work dichotomy as being the issue. The real issue is does it work like many things we already have or does it really, really, work. On that I remain skeptical.

    1. Mostly agree…but Norwood 5 probably means they expect to grow hair on bald patches too if the drug is effective.

      Even Follica expects to generate some new follicles by wounding.

  5. This is it. We finally have our moment and soon enough we will know if it does not work, works a little bit, or quick call a Barber. Hah.

    I think IF it does work that we will be able to get it a lot sooner than most people think. My guess would be Dec/19. All just a guess. Good luck everyone. Keep those fingers crossed.

  6. Adding, I would like to thank the Admin for having such an open mind about JAK over these past two years. I had a wild hypothesis based on Sporadic Facts regarding decade old and lost forgot possible Facts.

    Almost everyone disclaimed JAK but he held out hope and last I remember had it as a 50/50 chance or working a year ago. Long before we had more facts that suggested it could work.

    I am very Hopeful. And this is No Peach Fuzz its potentially your entire head of hair back as JAK just re-turns on your hair cycle from Off to On. Lets also hope their are no side effects.

    The Clock is Ticking and we will soon know.

    1. Thanks nasa_rs.

      I believed in it from the get go after Dr. King said in 2014 that we should definitely test it out for AGA, but became a bit skeptical later on when Dr. King became less optimistic.

      Aclaris’ rapid moves and investor presentation combined with some of your (and others too) scientific comments on here regarding JAKs have reinstated by hope. But still at 50/50.

      1. One could argue that there really is something to their rapid movement especially considering the connection with Walker and Follica. It’s possible that they are determined to release a topical JAK inhibitor even if it’s only moderately effective.
        I’m of the personal opinion that absolutely nothing in the near term will represent an extremely effective treatment which is why I actually have faith in Follica at this point. It’s also why I have zero faith in a company like Histogen.

        At the risk of going a bit off topic, I don’t believe any single treatment in the near term is going to be a game changer by itself. People wanting a miracle treatment are going to be waiting a while (IMO). However, combination treatments can be quite effective. Some people, including myself, have already had success with kitchen sink type “ghetto” approaches. If you aren’t willing to wait for the miracle cure that’s your best bet. Ten years ago Follica was focused on a miracle style cure. They failed. These days the seem far more interested in releasing a platform that will consist of multiple ever-expanding treatments and seem determined to actually release their program. They have tons of patents for using all sorts of different techniques and potential drugs. It may be that Aclaris is determined to release a topical JAK inhibitor because they strongly believe it will be a key element of some sort of combination therapy that either they or Follica will offer.
        If this is the case, then they would have very strong motivation to release it as soon as possible even if it’s not some sort of quantum leap.

  7. I like the article Title, The Countdown Begins.

    I have strong reasons to believe it will work. Now we are about to have proof, either way.

    If it works another Countdown Begins the Final Countdown – when we can order it.

    We are almost there.

    1. I always hated that song by Europe, but now I find myself chanting it out loud with my fist pumping in the air!

  8. ADMIN was way ahead of everyone in believing that JAK could possibly work.

    If this works, the Countdown becomes how long until we get put the Lotion on our heads. Amazing to think we are getting that close.

    1. They first with both Oral and Topical trials for Alopecia Areata and several months later they just started Topical trial for Androgenic Alopecia (MPB). It seems that trial started March 22, 2018 and it might be a rolling trial where they add a few people over a several month period.

  9. I have mentioned on this forum before.. if trials show a promising sign, 110% sure a photo(s) will be leaked to the press. expect CEO to show up in CNN or something… one photo will suffice. will be known in 1-2 months

    SILENCE means definite show stopper. They have no reason to be silent. all patents obtained, technology is top notch.

    1. Yeah I am going to watch Aclaris (ACRS) stock very closely. It’s trading at $17 and if the CEO just bought 10,000 shares then either he has some short term pump and dump plan going on or he knows this is the real deal.

        1. There is such a thing as “legal insider trading” and it happens daily.This is not insider trading. Insider trading is when you make trades based on confidential information (non public) However, It would be insider trading say if they get a tip that JAK is useless or causes cancer or whatever and they sell their shares early before it is public knowledge. Martha Stewart did something like that give it a read. It’s a fine line between legal insider trading and illegal insider trading.

            1. Ya its legal they have to report it to SEC All insider trading used to be legal pre 30s until realized its free money for infinity at the expense of the other side there are still advocates of the old system because they think its a fair game warning shot for the rest.

              PolarityTE ACLARIS and VIRTU execs have a good track record

    2. Totally agree @donitello – no news is BAD NEWS!

      That being said, I hope the difference, if any, is visible with the naked eye.

      1. Well here is the good news, follica was on NBC news back in 2008 demonstrating their new treatment grows new hair..so they were not silent. Can’t get more reputable than national news from a leading news channel. Jak was also on the news for Areata. Sisheido was on a Japanese news channel as well. Tsuji was only in online news. The rest like Rivertown, brotzu, kelopesia etc were only discussed on online blogs. I’m still very hopeful for follica. They are still on track within fda timelines. They initiated trials back in 2008. Most trials take an average of 10 to 12 years for release. People on these forums tend to forget this. No exceptions for hair loss drugs just because we want it so badly. I’m still going with follica and Sisheido before 2020. Everything else like jak, tsuji, etc 2022 or later.

        1. Do we know why Cots is / was not presenting Follica during one of the recent / upcoming congresses? Someone here made the funny comment that Cots would only be helping with the beamer …

          1. Yeah that was my comment :-) Cots is like the Steven Hawking of the hair loss world. All the enthusiasm, popularity and seeming credibility, minus any invention to his name worthy of his reputation. What we need is an Elon Musk, someone who can actually deliver, and I see Shiseido and Aclaris being that.

  10. Agree with @donitello. No news is bad news.

    https://truthtoday24.com/united-states-androgenic-alopecia-drug-market-report-by-company-regions-types-and-applications-status-and-forecast-to-2025/

    Androgenic Alopecia Drug market 2018 report particulars outgrowth inhibiting factors, evolution contingencies and investment feasibility of Androgenic Alopecia Drug industry along with the forecast period from 2018 to 2025.

    Well, in a few words: In the period (2018-2025) We will have new treatments for androgenetic alopecia. (You have to read between the lines). Nice.

    If someone wants:
    https://qyresearch.us/report/united-states-androgenic-alopecia-drug-market-2018/#inquiry

    GREAT BLOG.

  11. Apologies if this question has been answered already:
    Considering I’m not only balding but also greying, I wanted to know whether the new hair grown by JAK would then also be grey?

  12. I’m in Denver, but not sure I would want to be part of a clinical trial at this point. Definitely pros/cons to consider.

  13. If shiseido doesn’t announce this year they got nothing

    They have had ample time and they would know and announced they would release. This is the biggest year for replicel shiseido its make or break. I will buy asap after shiseido proves it. If they do

  14. Almost 1 month since the trial began (March 22). It should take another 5 weeks to know if it is working and how well it is working. If it works well then the next countdown is the one for when we simply are waiting for our prescription to be filled. Then HAIR.

  15. I really wish that jak work for age old condition of baldness.

    Nasa_rs how you know that we should have to wait 5 more weeks??

    Is it confirmed that trials began on 22 march?

    Somebody was commenting here that companys recruiting process is running.

    1. What they tend to do is start a New Batch of Test Subjects every ~6 weeks. Just a guess.

      AA type hair loss who degree hair it took them ~3 months to get hair growing dense enough to see any good results, and 5 months for full set of hair.

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