An Overdue Aclaris Update

Update: February 29, 2020

Aclaris Exits Hair Loss Business

Recent rumors are, unfortunately, very true. Several days ago, I contacted Aclaris Therapeutics’ Head of Corporate Strategy Mr. Michael Tung. I asked him for any update on their androgenetic alopecia (AGA) JAK inhibitor product. His short and succinct response was as follows:

“We exited all of that unfort”.

I am disappointed, but was expecting this bad news. Their pipeline page no longer even shows any products to target AGA or Alopecia Areata (AA). Last year, they were searching for a partner to help further develop their “investigational compounds” ATI-501 (oral) and ATI-502 (topical).

Sorry to reader “nasa_rs”. However, not a big surprise after the past year of limited information releases by Aclaris regarding their alopecia products.

March 18, 2019

Aclaris JAK Inhibitor Trial Update

I used to cover Aclaris Therapeutics and its topical JAK inhibitor product for androgenetic alopecia fairly regularly. However, there have been very few significant recent updates.

Today morning, Aclaris released a summary of its FY 2018 results. The most relevant part for us concerns the ATI-502 topical Janus Kinase (JAK) 1/3 inhibitor product for AGA. They also seem to name this same product as AGA-201 and ATI-50002 in other references.

Per the latest news, Phase 2 open-label clinical trials for ATI-502 (a topical JAK1/3 inhibitor) involve 31 patients with AGA. Interim 6-month data are expected in the second quarter of 2019, while comprehensive 12-month data will be realized in the second half of 2019.

So by the end of this year, we should finally have at least some idea on whether JAK inhibitors can at least somewhat help patients with AGA (aka male pattern hair loss).

The trials will measure both safety and efficacy.

We already know beyond a doubt that JAK inhibitors significantly help people with the less common alopecia areata. As well as thos with its various related forms (alopecia totalis and alopecia universalis).

68 thoughts on “An Overdue Aclaris Update”

  1. I would prefer stem cells/implants by Shiseido/Riken rather than some sort of regular drug, but if it works I will take it, regardless of risk or price or however far I have to travel to get some.

  2. I think Jak inhibitors are very effective; but the question here /
      Will it be a treatment for a defined period of time or is it life-time like minoxidil?

  3. AFAIK, hope was raised originally because dormant human hair follicles transplanted to mice responded well to JAK inhibitors and began to regrow. However, a mouse does not have a human immune system and the mouse immune system was suppressed with drugs so as not to interfere with the experiment. So the big question is how these drugs will work as they interact with a human immune system and other human enzymes.

  4. Thanks Admin. My hopes are placed on Aclaris and Riken! Very cool that we’ll definitely see some Aclaris results soon.

    Please press Riken for info whenever you get the chance. Dig, like the journalist you are! :-)

  5. Please read my comment in the last post regarding ebv and autoimmune problems and tell me what you think. Jak might not work but they could be on the right track

  6. Where’s NASA RS? He’s like the Sonny the cuckoo cocoa puffs bird for Jak inhibitors with AGA, NASA’s Cuckoo for Jak! I’ll take his unbridled optimism over the opposite mentality or fear mongering any day.

    1. Yoda, Agreed on NASA. I have to remain cautious with my optimism, though. Ever since Aclaris designated AGA treatment “exploratory”, I’m pretty sure that means they’re just exploring the idea (and haven’t seen a viable breakthrough).

      That said, Riken is promising big things in the next couple of years, so I’m praying they’re legit.

  7. Riken is definitely interesting and possibly the holy grail. However, my observations tell me that IF it’s successful it’s more than a couple years away before being commercially available to most all people. And yes, this includes the Japanese market. I have no inside info, no crystal ball and could be wrong, which I hope I am.

  8. Bring on the JAK news, bad or good let’s just know and to plan.

    For something that does not work they sure are spending a great deal of time on it. I think the question is not DOES it work by HOW WELL does it work. A couple of strands of hair OK we will toss it but significant hair now we are talking.

    It’s going to happen in 2019 in the next 3-6 months.

    Funny how some actually FEAR that we might have good results then what do they do? People get used to anything but not me. I want the truth then the treatment.

    You know where I stand.

    1. Adding, Admin keep up the JAK update every month as this information will come out Very Soon and the Results could be Extremely Important.

        1. Drum roll please…it’s Nasa_RS finally with a comment on the JAK update! Is the Pope Catholic, does a bear crap in the woods, the tide goes in, the tide goes out! Yes Admin, there should be a JAK update every month even if there’s absolutely no news. At least we’d get the optimistic stylings of one Mr. Nasa_rs!! :-)

  9. Nasa aren’t you disenchanted with JAK if it arrives at market in 2023 ?

    I would love to buy some on some sketchy internet offshore pharmacy but it’s pretty dangerous right? And the Christian formula is quite particular trade secret in its delivery. So all these things are killing my buzz

    1. Let’s find out IF JAK works and how well. Then it becomes like the movie, It’s a Mad Mad World where everyone here’s about the location of buried treasure then they all take off in all directions trying to get to the same place… placing an order for JAK. Hah.

      I’m a bit optimistic there must be something for them to take this long.

      All my opinion.

  10. https://finance.yahoo.com/news/edited-transcript-acrs-earnings-conference-215835332.html

    There is a little bit of JAK info from Aclaris recent earnings release. In essence (good or bad) in talking about dermatitis it mentions that hair growth can occur when some have this disease. Also states that AA grow hair with topical JAK and no signs of side affects or other issues. Also states they will be excited to release the data once it becomes available for JAK. JAK just seems to work for all different types of hair loss including disease that it probably works for male pattern hairloss is my guess.

    On pure speculation, I think it works just not on everyone that it will not be the complete cure for everyone that it probably greatly increases hair growth and it might take a few years to get a full head of hair. Just my feeling. Although it does not matter we will have the facts in months, by the end of the year but my guess by end of summer.

  11. Its trading around 6 bucks… With a high of 30. If the news is dramatic enough it could quintuple+ again. I might throw down a few k on that around autumn.

    Also I feel like an idiot that I just found out 15 minutes ago aubrey degrey and Michael west launched AgeX on the NYSE. and it briefly quintupled following ipo. That’s an exotic company right there.

    What a day we live in.

  12. As for the recent Replicel ‘First-In-Japan Strategy’:

    Unless Shiseido decides to launch earlier, Replicel is anticipating RCH-01 to be available in Japan by 2022.
    https://www.replicel.com/news/replicel-reignites-its-first-in-japan-strategy

    They next-stage trial will also be in Japan and will, if I’m not mistaken, commence only after they release their dermal injector; so Replicel Phase 2 in 2020 in Japan.

    *looks like I’ll need to work on my chopstick technique*

    1. Toccata, it is an amazing country. One of the best in the 33 countries I have been so lucky to visit. The gadgets are second to none and the crime rate is so low the police in Tokyo spend half their time helping lost tourists.

  13. I have been on the Aclaris ATI-50002 trial for about a year. 6 months was random and this last 6 months was a guaranteed full dose. I was just informed that the results have been very disappointing and Aclaris is halting trials. Oral trials have been successful and will move forward. I don’t think a topical solution will ever work for substantially growth. I was on the trial for alopecia but was also putting the medication on balding areas not affected by alopecia. I honestly had better results with Rogaine foam. I think there is great hope for regrowth with oral JAK type medications if you are willing to monitor your blood regularly for any side effects.

  14. Their before and after photos of their last trial were appalling. An act of desperation. I believe this year will see other players throw down the gauntlet.

    1. Throw down the gauntlet? I don’t think so. More like throw up a white flag.

      But don’t worry guys…. …Just 5 more years! lol

  15. Even if this worked and worked well the fda would never approve a mpb drug that messes with your immune system. Cots himself said jaks don’t work for mpb. Christiano as usual made up some bs for publicity. Her rapunzel company probably will take another 20 years before anything materializes.

    My gut tells me we will have Follica as the main new regeneration treatment along with CB as the new propecia and SM as the new minox.

  16. The more I read, the more I’m convinced there’s no treatment coming any time soon. Went to turkey last year and got FUE. Best thing I ever did.

    1. Agree Jimmy. I had a HT in 2009 thinking it would carry me until a cure. Here we are in 2020 and nothing. I’m thinking about a top up HT to fill in general thinning on top and crown.

  17. What a shocker! Did anyone seriously believe this was a viable solution. Jak inhibitors are so toxic and the usage they were talking about was unrealistic even if they did anything, which suprise suprise they did nothing. I feel bad for all those people who were holding out hope for this snake oil. It was clear that it had no chance of working when they first investigated it years ago and had no results. Changing the vehicle, dose, dosage, and frequency was all smoke and mirrors to continue funding. It’s sad really. I was really hoping i was wrong.

  18. I’m surprised they’re canning the AA treatment as well; the results seemed to be a boon to AA sufferers.

    I agree that these drugs were quite risky for a cosmetic problem; I’m not certain I would have taken them. If they had provided the dramatic results we saw with AA though, I sure would’ve been tempted!

  19. Not surprising, engineered follicles are the only solution.
    A little off topic but admin, what’s your thought on corona virus possibly delaying the development of hair loss treatments going on currently? The thought isn’t that unreasonable since we already observe employees to stay home across the world. And a lot of R&D takes place in Asia.

    1. Imagine the optimistic hysteria if one of the victims grew back a single hair follicle viewable only by microscope? :-)

    2. Hi Red, if it gets much worse, I can see delays in research. For now, I am only seriously interested in Riken/Tsuji and Shiseido in Japan (when it comes to Asia).

  20. What?! That’s very disappointing, I’ve had high hopes for this one (still have).
    Are they going to publish the trial results? I mean after all they are a small company (~40m market cap) and maybe just prefer to prioritize other products?

    BTW ginger is a natural JAK inhibitor and when I searched the internet for ‘ginger hair growth’ for ‘ginger alopecia’ there are many people who swear by it (even there’s one YouTube video I could find that brings a study that suggests that one of the ginger compounds called ‘gingerol’ has an opposite effect, literally all comments below the video are of people who say how they only experienced hair growth – I guess it has contains hundreds of compounds so can’t judge by a single one).. I applied it once to my scalp in the past but haven’t persisted with it, was kinda waiting for the JAK inhibitors results.

  21. It’s interesting to reflect on what we knew that could’ve led us to this conclusion of no cure..
    1. Dr. Angela Christiano left her research with jaks to explore new hair loss cure options (very early on)
    2. The Aclaris website made a point to say “exploratory” next to AGA (meaning they were only experimenting for a discovery of viability)
    3. Many people taking jak inhibitors for other medical reasons never regrew their AGA pattern hair… only the DHT resistant hair
    4. no photos.. ever (which is true of so much research, unfortunately)

    Despite all of that, we had some reason for hope for a new delivery mechanism of some kind. That said, my optimism was always very cautious on this one.

    1. Tom, LOL I’ve already reached that point. Why even bother with mice as there seems to be no relation to humans whatsoever.

    1. Of far more interest, human-to-human hair transplants seem to be closer to reality. I hope to update my old post on that subject at some point this year.

      1. maybe people will sell their hair follicles for money? I guess some people have a few to spare. I recommend putting the donation clinic in Vegas! :-)

        1. Hi all, first time commenting here. Thank you admin for all the work, much appreciated. I think this one, combined with hair cloning, would be revolutionary. You can extract follicles of different types of hair from different people, let’s say 30follicles, multiply them to create farms of these different types of hair.
          You’d just walk in, chose the type that looks more similiar to your type and just get get them injected.

            1. I think it would speed up the whole process. You would just have to go once, no need to extract your own follicles and wait for them to moltiply the follicles. It would be mass production. Just my idea tho

    1. dude, nothing will get done at these medical places if Coronavirus is on everyones mind…hopefully these great minds don’t get sick or we’re screwed

      1. Why is he sick for suggesting that? Or is that just a kneejerk reaction on something you haven’t thought through? Are doctors and hospitals “sick” for transplanting organs from the deceased to those in need as well? Is the developed world sick for having organ donor right on your license? No? Then think before you post.

    1. https://www.youtube.com/watch?v=2QHDiVtGvB0&t=2s

      Here is an update. IMHO results are impressive, since the the patient is NW7 guy who is not suitable for transplant. Results suggest that you need to have some density so that exosomes could bind to something. Other thing is the cost, if they can find cheper source (ex. DP cells over umbilical cord) cost would go down dramatically, only hope is that quality doesn’t go down with cost.

  22. This is ironic.. Were are finally in 2020 and our best hope fall apart. Everything about Cristiano Angela, jak inhibitor….

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