Update: January 13, 2025
Dermatology Times interview with Eirion CEO Jon Edelson (h/t “John Doe”).
Update: January 8, 2025
Eirion Therapeutics Announces Successful Results from Phase 1 Clinical Trials for ET-02
Eirion Therapeutics just announced the successful results of its first-in-man Phase1 clinical trial for the treatment of androgenic alopecia for its topical pharmaceutical drug ET-02. Per the press release, Phase 2 clinical trials with 150 participants will begin in 2025. They will measure safety and efficacy over a a 6-month treatment period.
- The trial was double-blind and placebo-controlled, and consisted of 24 subjects at 3 sites in the US. It divided these subjects into three groups who were treated once daily for 4 weeks with either: a control treatment consisting of the product vehicle; a 1.25% solution of ET-02; or a 5% solution of ET-02.
- 5% ET-02 resulted in a 6-fold increase in non-vellus hair count compared to the placebo group at the end of the fifth week of the trial.
I am not too excited as yet due to the small size of the study.
They also say the following, although I am not sure if “experimental graft model” equates to actual human scalp conditions:
“The net rate of hair growth produced by ET-02 in the fourth month of treatment was four times greater than the amount produced by minoxidil in a second, separate pre-clinical study using the same experimental graft model.”
September 29, 2024
I first mentioned privately-held Eirion Therapeutics (US) in a 2020 update in my post on reversing grey hair. In recent years, a number of people have discussed this company in the comments in this blog.
I was reluctant to write an entire post on Eirion (incepted in 2016) for various reasons:
- The company’s website is not SSL/https compliant. A rarity these days. Edit: It stopped working in December 2024, but then restarted working as an SSL compliant site.
- Its pipeline page link goes to a strange Wixsite. Edit: Corrected in January 2025.
- Its website has “Copyright 2021” at the bottom. Edit: Corrected in January 2025.
- Its news page had 0 updates in 2023 and 1 update in 2022.
- It had yet to commence Phase 1 Clinical trials.
However, the last point above changed on July 1, 2024 and I have now finally decided to write this post. Also of note, in 2021 Eirion raised $40 million in a Series A investment and licensing deal with Shanghai Haohai Biological Technology.
Historically, I have avoided writing posts on companies that are yet to commence clinical trials. Not that it makes much of a difference when it comes to my wasting of time. In almost all cases, companies that conduct successful initial trials for a hair loss product still never succeed in bringing it to market. Although this is now changing with the shortcut cosmeceutical-first approach (e.g., KX-826).
Eirion is working on oral and topical treatments for both androgenetic alopecia and hair greying. And in each case, for prevention as well as reversal. The topical product is called ET-02, and the oral product is called ET-03.
Eirion Therapeutics Begins Phase 1 Clinical Trial for Topical ET-02
ET-02 has a novel mechanism of action that works by converting defective or inactive hair follicle stem cells (in men suffering from pattern hair loss) to normal activity and function. ET-02 does not target hormonal pathways like finasteride or dutasteride, so no side effects are expected. For grey hair, ET-02 could reinvigorate melanocyte stem cells.
Coming back to the double-blind, placebo-controlled Phase 1 trials that Eirion initiated in the US in July 2024:
- 24 subjects will be recruited to test the safety of ET-02 for the treatment of androgenic alopecia.
- The once daily topical treatment will last for 28 days.
- According to company CEO Jon Edelson, ET-02 has the potential to not only treat androgenic alopecia, but also prevent it.
Besides hair loss and grey hair, Eirion Therapeutics is also developing products to treat wrinkles and primary axillary hyperhidrosis.
Plasminogen Activator Inhibitor-1 (PAI-1)
While Eirion Therapeutics’ products’ exact mechanism of action is not clear, there are some hints online.
Per a 2023 dated notice on Renascience (Japan)’s website, it says that in 2016, Renascience (Japan) executed an agreement with Eirion Therapeutics. It grants the latter an exclusive license to develop, manufacture and commercialize RS5441 (topical and oral) for the treatment of alopecia and other skin diseases. In the agreement it says the following:
“In a collaboration with Northwestern University, the company discovered that overexpression of plasminogen activator inhibitor (PAI)-1 is involved in alopecia, and that inhibition of PAI-1 activates hair matrix cells. In fact, genetically engineered mice that overexpress PAI-1 showed significant hair loss, and when the PAI-1 inhibitor RS5441 was administered to this model, significant hair growth was observed.”
Renascience’s pipeline page shows a few serious medical conditions that the company is attempting to treat with PAI-1 inhibitors. The company is not focusing on dermatological problems.
Also of note, Eirion CEO Jonathon Edelson has a patent to his name related to plasminogen activator inhibitor-1 inhibitors and their potential to treat and/or prevent certain dermatological conditions. The patent specifically points out the treatment and/or prevention of graying hair.
Nanoparticle Compositions to Treat Skin Conditions
Also of significance, Dr. Edelson and Eirion Chief R&D Officer Dr. Klaus Theobald are together names on several patents. A key one that was filed in 2011 and entails the use of nanoparticle compositions to treat skin conditions, including hair loss. More here.
The original patent was filed in 2012 by Anterios (which was taken over by Allergan in 2016), and two of the three inventors are listed as Mr. Edelson and Mr. Theobald.
In the hair loss section of the patent, it says the following:
“In some embodiments, provided compositions are useful for treating and/or preventing hair loss.”
“In some embodiments, provided compositions for treatment and/or prevention of hair loss are formulated into a cream, liniment, lotion, gel, shampoo, conditioner, etc.”
A sizable list of potential ingredients such as parabens, oil and sodium chloride is also mentioned, but nothing stands out.
Other patents that include Dr. Edelson as a co-inventor and potential hair growth application include ones on: nanoparticle based dermal delivery; and nanoparticle compositions that contain one or more peptides.
I have maybe 2 white hairs on my head, but a beard that has more salt than pepper. I wonder what the protocol would be for someone like me?
Been following them since the beginning, alluring MOA.
The website is hilarious yes, but anyhow.
Every company which is able to start a human trial is already in the upper echelons of hair loss research.
The time they needed so far is embarrassing though, but that’s normal.
Rooting for them!
Seemed to take them forever to start clinical trials, they sound confident that it is better than anything currently for androgenetic alopecia and a treatment for grey hair is also a god send. Look forward to hearing of a phase 2 and some results hopefully don’t have to wait too many years :/
Some news regarding Amplifica:
https://www.prnewswire.com/news-releases/amplificas-amp-303-study-unveils-new-hope-for-hair-loss-treatments-302261925.html
Alas, it is disappointing.
While it’s not related to their hairloss trial, Eirion did have good news today with its wrinkle treatment trial. The more the company advances its pipeline, the more opportunities to attract private investment money.
https://ca.advfn.com/stock-market/stock-news/94644762/eirion-therapeutics-announces-results-of-first-in
We are in a little better situation than 10-15 years ago with all the imminent promises. We can with much effort use a combination of products that will stop or slow hair loss. Unfortunately it can be time consuming…I will join the 5 year club, I think that is when we will have single or two products that really work like osteopontin and/or some exosomes and/or some mitochondria boosters that work for me along with the usual oral Minox and topical Fin. (I am hoping to add a vitamin pack of growth factors, cytokines, exosomes for some regrowth called PTT-6. Again the kitchen sink method.)
Any updates on these guys? It’s been 5 months since they started recruiting for phase 1.
JT – One month later, your question is answered:
https://www.eirionthera.com/single-post/eirion-therapeutics-announces-potential-breakthrough-treatment-for-hair-loss-based-on-first-in-man-c
This has to be the slowest biotech company of the century lol
Also “For comparative purposes, after one month of treatment 5% ET-02 demonstrated more non-vellus hair growth than topical minoxidil produced after 4 months of treatment as measured in a separate clinical trial of minoxidil (N=180), the current “gold standard” treatment for androgenic alopecia.”
The 4X Minoxidil “growth rate” potential is even more exciting, albeit it was in an experimental graft model.
Sounds promising to me, especially given its mechanism of action. Could potentially stack with min and fin to make a substantial difference compared to current hair loss stacks. I’ll look forward to the stage 2 results, I need some hope in the next 5 years before my entire scalp becomes vellus hairs ;D
What makes it different from pp405?
So, it sounds like about 8 people had that very good result? Do we know if everyone treated with the 5% solution had a successful response? A positive response in 100% of patients is crucial. This seems like great news for something potentially far better than Minoxidil.
I couldn’t give a toss about grey hair. Got my first one at 25 (gleefully pointed out by my gf at the time). Now decades later I look like a corpse with koala hair. (Beating them off with a twig.) Currently shedding like crazy after upping the oral Min dose too. Hair strands not as fine, but still spooked when my comb gives me the middle finger every morning.
A few months ago I received an email from a friend, who told me to closely follow a company called https://unlimit.bio/. I haven’t paid much attention to what their specific therapy is, but I received an email from this company (I should have contacted them), communicating that they are already offering their therapy.
It’s a bad sign if the CEO is bald.
Man, they have just started offering the therapy… From what I have read, it increases the vascularization of the perifollicular area, which increases the irrigation and oxygenation of the follicles, making them thicker… It is a comparison with minoxidil , except that this compound is a protein produced naturally, and with androgenetic alopecia and aging it stops being produced, so its application in the form of an injection makes sense that it has a positive effect. We would appreciate any reader who lives near Honduras to try the treatment and document their experience.
Thanks for the find Alvaro. They have some photos on Twitter:
https://x.com/UnlimitedBio
Picking Honduras reminds me of Bioviva’s gene therapy testing a few years ago.
You’re welcome, administrator, anyway, I know that there are clinics that are currently treating osteoarthritis and osteoarthritis with mesenchymal stem cells. I don’t understand why there isn’t a clinic that offers it for hair, maybe there are other interests.
I signed up for updates on the Unlimit.bio website and got this Email now …
Hello from Unlimited Bio,
Thank you for your interest in anti-aging therapies. Since you signed up for our waitlist a while ago, we’re excited to give you early access to our treatments!
Here’s what’s new: VEGF Gene Therapy is coming to Latin America this January at the GARM Clinic on Roatan Island.
Our treatments help:
Boost muscle oxygenation;
Rejuvenate hair;
Improve peripheral circulation for PAD patients.
Let’s Connect:
We’d love to share details on our treatment protocols, pricing, and the next steps we have planned. Secure your spot to chat with us by clicking below or simply reply to this email if you prefer.
Book a Quick Call Here
Thank you again for your early support and for staying connected. We promise to keep emails minimal. If you prefer not to hear from us further, just reply “unsubscribe,” and we’ll promptly remove you from our list.
Warm regards,
Vladimir & Ivan
Team Unlimited Bio
lol
And those interests are that by multiplying the cells from the donor area and treating the area of alopecia, alopecia would be cured for many, and they prefer that we do transplants that make a lot of money…. WHAT A DISGUSTING SOCIETY. Instead of making progress that anyone who is stupid is stupid with or without hair, they prefer that and spend money on wars and useless things. If in the end we are going to die anyway when World War 3 comes. That they let us enjoy and advance in science, how disgusting.
Is there any way to get a Q & A with Eirion as I would love to know what they think of a timeline for marketing release if things go as planned this year and if they can release a cosmetic version after a phase 2 although I feel this will need a long term safety profile as it’s interacting with stem cells. So my gut feeling is that it is still many years away if it gets over the line.
https://www.clinicaltrialsarena.com/news/eirion-sees-success-in-first-in-man-topical-hair-loss-therapy-trial/?cf-view
“Jerry Shapiro, hair loss and dermatology specialist at the New York University Grossman School of Medicine, said: “Achieving this amount of hair growth in just five weeks in a clinical trial is unprecedented. ET-02 represents a potentially substantial advancement over minoxidil and other commercially available pharmaceuticals for patients struggling with hair loss, not only from an efficacy standpoint but also from a safety and ease-of-use standpoint.”
Nice interview
https://www.dermatologytimes.com/view/the-unprecedented-phase-1-results-of-et-02-for-the-treatment-of-androgenic-alopecia
Great find, thank you.
Let’s see if they can pull off phase 2 – Eirion has a history of needing many years for small steps, after all the company was founded 9 (!) years ago, yet they only made it to phase 2 with other products.
The MOA sounds more interesting to me than other interventions on the market and very similar to Pelage‘s.
Good luck to them.
Hi Ben, actually I was very surprised they release results only half a year after start of Phase 1. Now they go directly to Phase 2. After all the wait they go quite fast now.
Thanks John Doe for the 2 good links. Sounds like they are targeting a method of action very similar to Pelage by turning on the hair follicle stem cell. Not sure if it will have any bearing or put any pressure on Pelage, but it can’t hurt.
Pelage seems to be proceeding quickly and efficiently in the last 18 months regardless but maybe this adds a little motivation to show some results of their recently completed 2a trial. If you believe the 2 Pelage trial candidates who contacted Admin, I think the independently observed commonality between what Eirion and Pelage are finding from turning on the hair follicle stem cells is encouraging…….which is extraordinarily, and almost unbelievably, quick growth.
Did I understand correctly that phase 2 tests will be done at the end of the new year???
This is too far
Man I really want to hear some JUICY news this year (preferably from Organtech).
I can only imagine.
“After successful trials, Riken aims to release hair cloning to the public in 2027.”