Aclaris Updates Plans For Alopecia
Aclaris Therapeutics issued a press release on August 8, 2019 which outlined a new direction for their multiple alopecia programs. Additionally, Aclaris recently presented data from its second alopecia areata trial of the year.
Looking For Partners
There has been a mix of results from Aclaris’ three alopecia trials completed this year. Things started off well when the company announced its topical JAK inhibitor ATI-502 produced positive results in an open label trial treating men and women with androgenic alopecia. The females in this trial responded a bit better than the males. Less than two weeks later, Aclaris reported that the same topical formula ATI-502 did not meet its endpoints in a trial for alopecia areata. The significant factor in this case was the placebo performing as well as the drug in terms of efficacy. Then, more encouraging news came when Aclaris shared results from its trial of ATI-501, an oral JAK inhibitor to treat alopecia areata. ATI-501 met its primary endpoint and some of its secondary endpoints in that trial. All in all, a good showing which produced some dramatic hair regrowth photos from the AA patients.
However, following the news of the successful oral JAK inhibitor trial, Aclaris has announced a new plan of action for their entire alopecia program. A bulletpoint from the latest August 9th press release revealed:
- “Aclaris currently intends to seek a strategic partner to further develop its investigational compounds, ATI-501 (oral) and ATI-502 (topical) Janus Kinase (JAK) 1/3 inhibitors, for alopecia.”
Along with finding a strategic partner for its alopecia program, Aclaris has also mentioned its intention to improve the formulation of both the oral and the topical JAK inhibitors for various types of alopecia. In particular, the company believes it can improve its concentration of topical ATI-502 from 0.46% (which was used in the previous AGA trial) to a concentration of 3% or higher. On a conference call which took place the same day of the latest press release, Aclaris CEO Neal Walker further explained the reasoning behind the decision to seek help for its alopecia therapies: “These clinical studies are typically 12 months in duration and the length and costs associated with these studies makes it more advantageous for us to partner our alopecia franchise.”
While it is interesting to contemplate the possibility of Aclaris improving their formulation and partnering with a larger company to push JAK inhibitors through alopecia trials, there is one point that needs to be mentioned. Until Aclaris finds a strategic partner interested in developing JAK inhibitors for alopecia, Aclaris will not continue to carry out further clinical trials themselves. Thus, the future of ATI-502 for common hair loss depends upon one of the larger pharmaceutical companies being interested in giving it a shot. We will certainly keep an eye on Aclaris partnership news in the coming months.
ATI-501 Trial Successful For Alopecia Areata
As previously mentioned, Acalris recently presented positive results from its trial of ATI-501, a pill form of a JAK 1/3 inhibitor. JAK inhibitors have been known to produce some amazing regrowth results in patients with alopecia areata. We have seen these results dating back to 2014 with the Columbia University/Christiano trials.
Below are two examples that Aclaris shared in a recent powerpoint presentation for the ATI-501 trial.
Very encouraging for the alopecia areata crowd. If only we could get some drugs that produce these results in AGA.
Posted in Hair Growth Treatment
Both sites reported failure of topical jak inhibitors; is that true?
The trial for AGA was not a failure however it was an open label trial which means patients and doctors knew who was receiving the drug and also the drug was not compared against a placebo. For this reason it’s not as strong as a blinded/controlled clinical trial. But the data showed some hair growth.
There was breaking news back in 2017 that UT southwestern has found cells that are responsible for graying and balding and if i remember correctly it was KROX20. Do any body have any update on this? This news was picked by a lot of media but i haven’t heard anything.
Hi Lexington, good question I’ll see if there is anything brewing for the KROX20 development soon.
Hi Lexinton, if you happen to read this there has been an update on Krox20 on the Updates page.
wow industry is changing all the time. if aclaris slows down what is there to look forward to coming up?
Well, Shiseido is still in the mix and we can say confidently they have completed at least 90% of their trial if not the whole thing by now. Their results will be a big deal one way or another. Right now they are holding a lot of hope together for a lot of people.
Follica is up front and their trial for approval could begin by the end of the year. Can’t forget about Follicum too they are going into phase 2b for new topical formula in about 2 months from now.
What is your suggest now, should I wait Shiseido come out ,or fut/fue:? Tsuji is too expensive ，I was give up…
Well, Shiseido results really can’t wait much longer than the end of the year, it depends on if you can wait that long. Are you aware of FUT/FUE differences?
Thz reply, yes I know, still want wait the result after this year because alreday wait 6year ,my plan is shiseido》wait to tsuji drop price I saw u reply saw they alreday. Finish 90% but still no news ,u guest what time ?2020 ?
My guess is Shiseido needs to announce results of RCH-01 trial this year and if the treatment is going to be successful and launch. 3.5 years for an 18 month trial is pushing things to the limits.
Thanks for the update. It’s good to know where Aclaris stands right now. I look forward to some positive news in the future.
Yes, actually next 3 or so articles already lined up have good positive news! Things seem to be shaking and re-settling a little bit. Some expectations of treatments are not quite panning out, some hopefully will.
Hope medicine-Bayer in China after phase 2. cure will come from a big company in Asia
I bet some people will try to do their own topical JAK bc it is still several years away from market release.
yes, you may be right. But it seems the new higher concentration 3% jak that Aclaris has on the shelf now would be the one people would want.
Who are potential companies to buy Aclaris’s drugs for alopecia? Pfizer? Allergan?
Well, Allergan is eyeing Pelage pharma depending on their clinical trials and they have also invested into Stemson. They’re clearly interested in hair growth but you wonder how many treatments they are willing to bet on.
Pfizer actually has a JAK program for areata themselves which outperformed Aclaris’s JAK for areata, so it is unlikely that Pfizer would. There are options though.
https://www.renovacareinc.com/2019/08/renovacare_awarded_new_patent_allowing_for_the_spray_of_stem_cells_for_regeneration_of_organs_and_tissues/
Is this new treatment works in the treatment of baldness or not?
That’s an interesting product Ahmed although I don’t see anything listed for hair as of yet.
It’s looking more like cell therapies or a new otc that can work well is the best hope. Could be a long time here for news on jak drugs after this, hope it’s not.
Admin do you know how the saumued trial is going?
I have heard a brief update regarding the samumed trial and how it will affect the release of SM04554 in the US. Will share an article in the coming weeks. Still time left on the trial.
https://www.fiercebiotech.com/biotech/conversation-osman-kibar-ceo-samumed
Samumed’s CEO Dr. Osman Kibar gave interview to Fierce Biotech
Its alopecia treatment is close behind, with approval anticipated in late 2021 or early 2022.”
Thanks Ahmed, I have more detailed information about this. A statement direct from the company. I will post an article next week.
NGF574H any good review?have you heard any thing from Medipost?
thanks Admin
Still waiting for the product to reach the initial market. There have been samples passed around in Korea and some in Saudi Arabia, not many users yet. Results should be coming by end of September.
They must be very confident I have good feeling as well otherwise they wouldn’t pass around to test it before release and ngf37 have good response from users , hope something good turnout in September
Thanks again Admin