Aclaris Therapeutics and Dr. Neal Walker Update

Aclaris Therapeutics has been in the news a lot so far this month. The company has gone overboard with press releases and e-mail alerts (if you are subscribed) during the first two weeks of August. When I read all their recent press releases, I saw very little in the way of their topical JAK inhibitor program for male pattern hair loss, although one reader e-mailed me about one particular sentence in this press release in which they state that they will:

“Continue to develop another series of topical JAK inhibitors for the treatment of androgenetic alopecia (AGA)”.

Also of major interest is their recent purchase of Confluence Life Sciences.

However, something else extremely significant that I totally missed (despite my weekly Google Alerts about the company) was sent to me by a blog reader yesterday. It is a 10-page Seeking Alpha earnings call/interview with Aclaris CEO Neal Walker and others (can only be viewed in its entirety after registration). There are numerous interesting points in those 10 pages, but by far the most important for our purposes are the below two quotes from the CEO:

Mr. Walker: “We view the soft JAK as applicable to things like male-female pattern baldness”.

Shorty thereafter…

Mr Lugo: “Understood. What’s the timing for the soft JAK program entering the clinic? I’m not sure I heard that”.

Mr. Walker: “We will be giving a more full guidance on that at our Investor Day. We’re looking at approximately 2 years for some of our pipeline assets“.

My Thoughts

  • It seems like they are classifying “topical covalently bound JAK inhibitors” as “soft JAK inhibitors”.
  • Their collaboration and subsequent takeover of Confluence Life Sciences involves soft JAK inhibitor technology among other things. Mr. Walker points out elsewhere in the interview that their original reason for collaboration with Confluence entailed the latter’s soft JAK inhibitor technology.
  • I presume that Mr. Lugo’s comment about “entering the clinic” means being in use at clinics. It seems very hard to imagine that this can happen in two years as Mr. Walker seems to imply. Aclaris’ pipeline currently has both its hair loss related topical JAK inhibitors in pre-clinical trials. The only way they could get these to the clinic in two years is if somehow the US FDA has significantly less stringent regulations for topical versions of drugs relative to oral versions of the same drugs (especially if the oral version has already been approved or is in final phase 3 trials in two years).

So the JAK hope-train continues even if commentator “nasa_rs” is missing lately:-)

76 thoughts on “Aclaris Therapeutics and Dr. Neal Walker Update”

  1. Thanks Admin for this post, just in time for my birthday.

    It seems that my theory about the reason why Aclaris has acquired Confluence, has been substantiated by Neil Walker himself.

    I’m no science guru, but it seems that the strategy here is similar to that applied in politics; that is, to save the best card for last. By this, I mean that they might already know that Jak inhibitors are also effective for AGA. Perhaps, and this is just my thought, lab experiments have already shown a way forward.

    To be honest, I wouldn’t be at all surprised, if Aclaris acquires also UCLA’s patent mentioned in the previous post, as it seems that Jak-Stat/Jak inhibitors is the name of the game.

      1. Yes Admin, it was me. And you’re very welcome.

        Things are moving fast on Aclaris’s side of the fence. Maybe, all the latest scientific discoveries published lately (Tregs is just one example), might be the driving force for Aclaris to expedite the trials for AGA.

        Perhaps, like you’ve told me in your email reply, we’ll see that bottom title in Aclaris’s pipeline to start moving to the right, for phase 1.

  2. “The only way they could get these to the clinic in two years is if somehow the US FDA has significantly less stringent regulations for topical versions of drugs relative to oral versions of the same drugs (especially if the oral version has already been approved or is in final phase 3 trials in two years).”
    This question could be answered by checking the time for topical minoxidil vs. (previously FDA approved) oral minoxidil. One of you more ambitious, young bucks could play “CSI-FDA” and probably figure it out.

    1. And from the way I read his response on the CC it almost sounded like he meant the clinical trials* for AGA will begin worhin 2 years.

  3. Thanks Admin! Hopefully we’ll learn more on “Investor Day”. I’m just happy they’re still speaking on this topic and adding new buzz words to describe things… sounds like progress to me!

  4. More like the JAK “cope” train continues.

    Hopefully I am wrong, but I have yet to see a shred of sound scientific data or reasoning why this would at all be a potential cure, and Neal Walker has made some completely absurd claims that can easily be debunked by existing studies — such as his claim that oral JAK can’t sufficiently reach the follicle — and even if they do have some ultra-secret lab results that somehow spit in the face of all that, it is still years and years away.

    1. Sadly agree with you. I always get the impression that they are driving revenues with claims about MPB for investors so they can pump into other products which they can actually release.

    2. Neal Walker is not a scientist.Dr. Angela Christiano originally claimed that topical JAKs were showing some effect on male pattern hair loss too.

  5. admin
    I have an email from tissuse.
    the interview will available at the end of august!
    coming soon in hairlosstalk site…

  6. I guess “Entering the Clinic” just means starting Clinical Trials in 2 years. Thinking about the potential sides of JAKs like Cancer that would take at least 6 years for all 3 stages of the Trial. …. Fingers crossed I am totally wrong with that.

  7. This pretty much means 2 years till clinical trials. These trials will take long time due to the fact jak plays with the immune system and is a serious drug. I would say at least 7 to 10 years of phase 1 to 3 completion starting from today. I am starting to believe all these companies just use mpb potential cures to gain investment and funding for other products in their pipeline that actually work. We have follica, tsuji and sisheido. If these don’t pan out than I say nothing will ever come out for at least 20yrs that is worthwhile of using and growing back serious regrowth. It’s all games and politics in the pharmaceutical world. I’ll be happy to see something work better than Rogaine at this point and I will consider that a breakthrough. If jak really worked for mpb and acleris wanted to become instant billionaire overNight then would have released or pushed through phase 2 by now with jak for mpb as a cure for hairloss. Not wait 2 more years before starting phase 1. This sht is getting exhausting and Neverending. They will cure aids before mpb.

    1. I agree. Follica, Shiseido, and Riken are “the big 3” of the developing technologies.

      The first two we know work, but what their real efficacy is remains to be seen.

      We now know that, given TissUse’s response to that one email, that they are waiting for someone else to develop a solution to the cultivation problem. Tsuji is the only one who apparently has a method for this, and literally no one else is nearly as far along as Riken is, so we can safely assume they have no solution either.

      Tsuji is the ONLY hope for hair multiplication before anyone in their mid 20s (perhaps even younger) would be too old for it to really count.

      If these three companies fail — then we are screwed.

  8. When can we expect a complete cure admin? Life has become quite frustrating now . Losing all hopes. Someone please come up with a cure.

  9. They are definitely planning to bring the product out in 2 years..some of you guys are crazy.A number of oral JAKs are out and approved already, and the topical will cause almost no side effects and little systemic absorption.I read in the past too that the topical JAKs would be approved in 2 years.

    This is super super news!

    1. Yes Tsuji and Shiseido interview would be really great, especially if Shiseido still promises regrowth and not just mantaining

  10. Aclaris Therapeutics to Attend Upcoming Investor Conferences
    Aclaris today announced that members of its management team will present and host investor meetings at the following upcoming investor events:

    Management will host investor meetings during Citi’s 12th Annual Biotech Conference in Boston, MA on Wednesday, September 6, 2017.
    Dr. Neal Walker, President and Chief Executive Officer, will present at the Morgan Stanley 15th Annual Global Healthcare Conference in New York, NY on Tuesday, September 12, 2017 at 5:15 PM EDT.
    Dr. Walker will also present at the Cantor Fitzgerald Global Healthcare Conference in New York, NY on Tuesday, September 26, 2017 at 9:10 AM EDT.

    A live webcast of the Morgan Stanley 15th Annual Global Healthcare Conference and the Cantor Fitzgerald Global Healthcare Conference presentations can be accessed through the Company’s web site

    @admin, do you think that this is the investor day Dr.Neal Walker was talking about?

  11. I have an email from kyocera.
    The timeline for hair product is 2020 at the moment.
    Tsuji will start human trials in march 2019 and moving fast!

  12. Solid question MS….I am still upset that it looks like they will be using minox as part of their treatmemt. If only I didn’t get horrible side effects!

      1. I read they (PureTech) should present some results soon? Can somone summarise?

        What is more, I really think Follica can be used together with Brotzu lotion to enhance the effect and should be stronger than just minoxidil.

  13. Two questions. What is a Pivotal Trial, Phase 2 or Phase3? And how can the Trial only take from Q3 to Q4? Thats way to short for Treatment, follow up and Evaluation.

  14. Probably posted on a Follica article, but here’s a TED Talk by the other Scientific co-founder (other one is the always mentioned Cots) This guy must have stumbled upon the hair wounding thing because he seems to tackle slightly more important and child related skin issues. Anyways, he’s a great mind and I have no clue why anyone thinks this will be some simple derma-wounding-roller style device…very likely way more advanced with some sort of thing in the scalp they are specifically targeting. Wont be a cure like with most things, but like the other laser treatments, it clearly offers a significant improvement on average.

    1. Mother of god…you again. You know how to read? Riken/tsuji release for clinical practise in 2020. Hair transplant doctors should support this to 100%.

  15. Egg head as I read your last post I couldn’t help but hear journeys song don’t stop believing. Too bad I don’t believe. Now let’s all get excited about brotzu lol lol lol

    1. dont believe brotzu too much. we have seen several treatment disappear. we couldnt be sure until fidia release announcement.

  16. Being as how it’s not yet in clinical trials, I believe “entering the clinic” means clinical trials.

    There are plenty of better ways to say “brought to market”, but I sincerely hope I’m wrong.

  17. It is like a nightmare, because with brotzu there is somethingt out there that could really help all of us, but they are not able to produce a strong and stable version for big market. On HLT someone got a response from fidia which says that they are still testing….. forget about 2018.

  18. Hard to tell if “in the clinic” meant clinical trials or available for the public. Based off of the normal timeline through which drugs are inherently ran through one can assume that this probably means the latter as apposed to the former. However the 21st centuries care act being passed could significantly reduce time to market and this is already a medical technology in use for another form of hair loss in an oral form with a good safety profile.

  19. Really, if tsujji is able to do what we think they are going to be able to do by 2020 as they stated this is really all a moot point with anything else. Having the ability to clone DHT resistant hair with in unlimited numbers essentially amounts to a cure anyhow.

    1. this is a nice dream, I admit…but to think they will have zero setbacks or new challenges arrive is kind of Naive…I really hope they can figure it out though so it actually works like they intended.

  20. I love how people get excited about technologies that haven’t been realized yet. I remember being young and naive and doing the same after reading my magazine articles about baldness breakthroughs.

  21. Guys, I know it’s out of topic, but can you tell me what is going on with Shiseido. Last update is that they are planing to relise their product in late 2018. Is that truth? Sorry for my english.

    1. dont wait for nothing to come before 2019…maybe brotzu or follica nothing more will get to the market this time soon

    1. even if you have the money, you are going to be on a waiting list for years to come, China,Japan, India, have millions of balding middle class people waiting for Tsuji, we need follica , brotzu,sm,histrogen, etc to tie us over till Tsuji goes world wide, which could be years. Maybe i am wrong,
      and have plans for a few countries to start.

    2. Im kind of coming to terms with this it’s roughly $8 for 3 hairs now. Say your already horshoe and need like 70,000 follicles that’s $186,000. This therapy would be THE therapy for highly progressed balding persons and its going to be unattainable to 92% of them and its a shame so lets not talk about Tsuji anymore its not the cure for us unless you are very well off then congratulations I’m happy for you. Let’s talk about what we do have going for us for regrowth and not maintenance which issss… nothing… shucks.

  22. In clinic would mean initiating phase one trials. Preclinical would be prior to initiating drug trials.

  23. It’s sad that it seems like the brotzu lotion won’t work. I’m guessing it won’t work since fidia hasn’t said anything about it it probably doesn’t work or doesn’t work very well

    1. They stated early this year not to expect any news until 2018. If it didn’t show efficacy then they would have discontinued their treatment development after their first round of testing in 2016.

      The fact that they are continuing to develop the lotion after initial testing indicates that they believe that they have something worth developing.

      No news doesn’t always mean bad news btw. They’re a company, not a good will non profit organization. When they have something ready for market, they will release info. Doing so before that point is completely pointless and achieves nothing. Most companies operate this way, not sure why hairloss companies should be expected to operate any differently.

  24. All these negative but non contrictive comments are so gloomy yet bring nothing to the table. Go admin and wveryone else actually wanting a cure!!

    1. This brings things full circle since many years ago allergan tried to kill/sue histogen. Histogen won. now they are buying regenica/histogen skincare. If you cant beat them join them! Hopefully this gives histogen more access to much needed funding.

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