Aclaris to Enter Phase 2 Trial for Androgenic Alopecia
According to its latest press release, Aclaris Therapeutics will be launching a phase 2 trial for the use of JAK inhibitors in androgenic alopecia (pattern hair loss) within the next few months.
Here’s the line item from the press release about Aclaris’ trial in androgenic alopecia.
- AGA-201 Topical – a planned Phase 2 open-label clinical trial of ATI-502 for the topical treatment of androgenetic alopecia (AGA), also known as male/female pattern hair loss, which is anticipated to begin in the first half of this year. This trial will evaluate the effect of ATI-502 on the regrowth of hair in up to 24 patients with AGA and data are expected in first half of 2019.
The press release also mentions four other clinical trials for alopecia areata using JAK inhibitor drugs. These include:
- A dose ranging trial to evaluate ideal topical doses.
- A pharmacokinetic trial to evaluate how topical JAK inhibitors affect scalp biology.
- A planned dose ranging trial for the use of oral JAK inhibitors.
- A trial using topical JAK inhibitors to evaluate eyebrow regrowth in 24 patients with alopecia areata.
Further Pipeline Review
It’s interesting to note that the pipeline on Aclaris’ website shows the drug candidate ATI-502 at the progress of phase 2 for alopecia areata. The Aclaris press release from 3/12/18 mentions that the androgenic alopecia trial planned for 1st half 2018 will be utilizing the ATI-502 formulation. Their pipeline also displays a program for “Soft JAK Inhibitors” to treat androgenic alopecia, which is at a preclinical stage. It would thus appear that the “Soft JAK inhibitors” for AGA represent a separate drug candidate and are still being developed.
Aclaris Therapeutics Pipeline
Soft JAK Inhibitors are a product of the collaboration between Aclaris and a biotech firm which specializes in JAK inhibitor drug development, Confluence Life Sciences. That company was acquired by Aclaris late last year. Here’s a description from a previous press release describing Soft JAK inhibitors:
Soft JAK inhibitors may be topically applied and active in the skin, but will be rapidly metabolized and inactivated when they enter the bloodstream, which may result in significantly reduced systemic exposure. The JAK family of kinases are a subgroup of non-receptor tyrosine kinases that are essential in transducing signals originating from cytokine receptors, and whose enzymatic activity is essential for the biological activity of the cytokines in the immune system. JAK inhibitors may be useful for treating inflammatory and autoimmune disorders such as alopecia areata, vitiligo, atopic dermatitis and others.
This development would make Aclaris’ ATI-502 the second drug candidate to move into a phase 2 trial for AGA since the start of the year.
Any thoughts on how one could volunteer to be part of these trials? And where the trials are located (their press release just says 25 different locations)?
John, thanks for commenting. I definitely think contacting the company and asking for guidance on clinical trial enrollment is a good idea. Additionally, sometimes the trial listings on the clinical trial.gov website will have the trial centers listed.
How would this stop DHT? Lots of people seem very enthusiastic about this product but I just don’t understand how it would be effective for treating AGA.
Hi Michael, let me first say, I too, am not sure if JAKs will be suitable for AGA. The proposed theory has something to do with instigating the anagen growth cycle. If you read a past article on Follicle Thought about JAK inhibitors featuring Angela Christiano’s research you can see some of her work testing dermal papilla cell cultures with JAK inhibitors. The JAKs somehow had a positive effect. The scalp is a different ballgame though. We’ll have to see data from these trials. Thanks for commenting.
How do I sign up for a test recipient of the clinical trials? I live in PA.
Jeff, thanks for reading Follicle Thought. Please see previous response in this thread.
when will end ?? ! (Edited)
Thanks for visiting umut. We can always use another new approach, angle, company, version, etc.
Until a treatment is released to be available in a clinic or a pharmacy, the news is what helps us the most. Follicle Thought focuses on providing the most relevant and up to date information regarding hair growth treatment progress. Three years of weekly updates is preferable to three years of silence in my opinion. Please stay optimistic and keep your head up! There are good things happening behind the scenes!
TUESDAY, March 6, 2018 (HealthDay News) — Carboxytherapy appears to be a promising therapeutic option for treatment of alopecia, according to a study published online Feb. 20 in the Journal of Cosmetic Dermatology.
Noha Nabil Doghaim, M.D., from Tanta University in Egypt, and colleagues randomized 40 patients with alopecia areata and 40 patients with androgenetic alopecia to receive either carboxytherapy or placebo. Study participants were followed up with monthly for three months.
The researchers found that the alopecia areata patients showed significant clinical improvement in Severity of Alopecia Tool score as well as dermoscopic improvement after carboxytherapy. Specifically, there was a significant reduction in dystrophic hair, black dots, yellow dots, and tapered hair, plus significant emergence of regrowing hair. Patients with androgenetic alopecia showed significant clinical and dermoscopic improvement after carboxytherapy plus significant increases in hair density as measured by digital dermoscopy. During the follow-up period, there was regression of the results, but measures were still significantly better than before treatment.
“Carboxytherapy seems to be a promising therapeutic option for patchy alopecia areata and could be helpful as an adjuvant therapy of androgenetic alopecia but more than six sessions are required and adjuvants are recommended for maintenance of the results,” the authors write
Thank you Bekeero!
Administrator, you’re doing a really successful business. I respect you, but tell us something on the net. do you think he’s going to find a solution with a patient, what and when?
If you mean do I think Aclaris will find success with a AGA patient? At this point it’s hard to tell.
If you mean any treatment finding success for AGA, I think Shiseido and Fidia are both very important and could be out this year.
Will the Shisheido treatment also be available in Europe when it comes out in Japan? Or do we have to wait longer? Any ideas about the price of this treatment?
Thanks for reading and commenting. I am certain that the treatment will only be available in Japan upon first approval. I have not heard any official comment about a number on the price, but I believe Replicel has said it would be very competitive compared to hair transplants.
Hello! Tell me please at some stage now development of ointment on the basis of JAK-inhibitors, for Treatment Of Alopecia Areata ! From Angela Christiano?
The article explains it, Ruslan. Clinical trials going on now.
Can any of these options help women with scarring alopecia?
Hi Coleen, I’m sorry I’m not sure about that. I have not heard many companies discuss scarring alopecia. If I hear anything regarding that subject I will share the info.
My husband and I would like to be a human trial for hairloss.
when will be the medications available for Alopecia patients in India?
Hello! Tell me please at some stage now development of ointment on the basis of JAK-inhibitors, for Treatment Of Alopecia Areata ! From Angela Christiano?
Hello! Tell me please at some stage now development of ointment on the basis of JAK-inhibitors, for Treatment Of Alopecia Areata ! From Angela Christiano?