February 6, 2024
Technoderma Phase 2 Trials Success
Technoderma’s Phase 2 clinical trials for TDM-105795 have succeeded (h/t “Flynn”). This Chinese company came out of the blue last year via its unique thyromimetic drug. Per the results of this trial:
- The non-vellus Target Area Hair Count (TAHC) showed a mean increase from baseline of 24.3 hairs with the high-strength (0.02%) dosage topical solution. And an increase of 20.3 hairs with the low-strength (0.0025%) topical solution. This compared with a 14.0 hairs increase with placebo in a 1 cm2 test area.
According to the company’s chief medical officer, TDM-105795 has demonstrated hair growth in AGA with a favorable safety profile. They will therefore move forward with the clinical program.
TDM-105795 has poor systemic absorption after topical application and a short half-life. This makes the drug well-suited to avoid causing unwanted systemic effects.
Per CEO Zengquan Wang:
“We are committed to developing a portfolio of innovative dermatology drug candidates.”
April 12, 2023
In February, someone e-mailed me a news link on Technoderma (China)’s site. At the bottom of that page devoted to dermatitis was a section on androgenetic alopecia (AGA):
“Previously, the company has completed the phase I clinical trial of TDM-105795 tincture in androgen alopecia (AGA), and is expected to initiate the phase II clinical trial in the middle of March 2023.”
On the company’s site, it says that TDM-105795 is a “first-in-class” small molecule thyromimetic drug candidate. It is being developed as a topical drug for treatment of androgenetic alopecia. Thyromimetics are synthetic analogs of thyroid hormones.
A 2022 study from China found that Technoderma’s thyroid hormone receptor agonist promotes hair growth in mice. They called the molecule thyroxine receptor agonist TDM 10842. The researchers suggest a potential mechanism to be the activation of Wnt/beta-catenin and Hedgehog pathways.
Note that the hair growth resulted via “the early induction of anagen” so it is not brand new hair. However, a prolonged anagen phase might make one’s remaining hair more resistant to the ravages of dihydrotestosterone (DHT). And perhaps help regenerate some recently miniaturized hair.
The Thyroid Hormone and Hair Growth
- A 2016 study from Europe concluded that the thyroid hormone analogue KB2115 (Eprotirome) prolongs the human hair growth cycle (i.e., anagen).
- A 2010 US study found that a thyroid hormone receptor beta subtype-selective thyromimetic 5 was efficacious in mouse and monkey hair growth after topical application.
- A 2008 study even concluded that thyroid hormones (besides prolonging the anagen phase of the hair cycle) impact hair pigmentation.
Technoderma Begins Phase 2 Trials
Earlier today, someone e-mailed me that Technoderma just began recruiting for their Phase 2 clinical trials in the US per a Reddit post. They are moving just as fast as the other Chinese company Kintor Pharma.
The clinical trial page states a trial start date of April 17, 2023 and a completion date of November 30, 2023. Update: Now confirmed. First doses given.
They are looking for 72 volunteers. The sponsors and collaborators are listed as Technoderma Medicines Inc and Therapeutics Inc (a dermatology contract research organization).
The clinical trial page lists three research locations in Oregon, Texas and Virginia. However, per the Reddit post, there are thirteen cities across nine states where you can get recruited to participate. I will not post the city names or the contact person’s e-mail here for now, but you can check the Reddit.
I posted this right away because the 72 participant capacity will likely fill up very fast.
Thanks for covering Technoderma (the first time I think). I‘ve been following them for quite some time now. Just some random thoughts:
– [ ] the thyroid pathway was always intriguing to me as a possible treatment. There’s quite some research about it as admin mentioned above.
– [ ] Technoderma needed 2 damn years from start to finish for trial number one. Apparently the treatment time was only for 4 weeks. Lots of question marks here. If everything goes well this time we might see results of trial 2 already this year.
– [ ] Ralf Paus is currently doing a study on topical T3/4 funded by the HairDAO. Apparently that was his first suggestion as he suspects it to be effective and quick to market (T3/4 is already approved).
Altogether great to have another candidate in the second trial!
Mice are not good animal models for testing drugs.
Just look what happened to Vedere Bio. They had great results in mice, but failed in clinical trials. Plus, they got funding more than 130M dollars. Now they shut down the company.
https://www.biospace.com/article/vedere-bio-ii-closes-its-doors-after-preclinical-studies-miss-high-bar/?utm_campaign=Daily%20Social%20%7C%20News&utm_content=243841660&utm_medium=social&utm_source=twitter&hss_channel=tw-21793154
3D/4D bioprinting tissues, organoids/shperoids, organ-on-a-chip will be much better and predictible models for drug testing.
No offence Bryan but what about hmi 115 showing results in AGA bearing macaques? It’s the same gene and pathology as in humans.
Mice are different than the macaques. Several hair products have succeeded on Mice but not on humans while the Stumpped tail Macaques have been more aligned with humans with regards to Fin and Minox when tested as well as other products I can’t remember right now. If I remember correctly the mice can show that it is reasonable safe, but the Macaques can show it is efficient.
We’ve seen mice studies over and over but fail on humans. Please explain how this will be any different. There has to be a better and faster way!
Stumped Tail-Macaques has Androgenic Alopecia and goes balding through life.
They are better models for hair loss drug testing. But, probably very expensive and hard to breed.
I bet this will fail like Kintor.
Hard to keep everything straight. Great that there are so many players now, however does anyone believe that a new treatment will be out in the next three years that will be an incremental improvement over fin/min in terms of results? Admin? Not necessarily a game changer, just an improvement, side effects aside.
It likely depends on how fast the Japanese and South Koreans can move with more favorable regulations. I do not see US companies moving fast.
Personally, I think we would be very lucky if any semi-game changing treatment were available in 3 years. I suppose it is possible that if an early trial produced some undeniably good reuslts after 3-6 months of treatment, there would be a fast track mad dash to approval, but I think that would be unlikely. Realistically, I think we will be lucky if we just see “undeniably good results” from anyone at any trial stage within 3 years. But just knowing there was a solid new treatment coming that would do something undeniably positive would be a huge mental relief from my perspective.
Isn’t that a better result than HMI-115?
This would definitely be a marketable product, although daily application is a pain in the ass.
What I find confusing is that the actual numbers (TAHC) often sound underwhelming, but when seeing pictures it looks better than the numbers would indicate?
I sense some disappointment regarding all those new medicines (Kintor, HMI, Technoderma) but it’s always a matter of expectations. I doubt that there ever will be a topical or injectable which gives you 100 % regrowth. A full cure can only be haircloning imho.
I also wouldn’t underestimate the synergistic power of two or more of these new treatments.
I would add to my comment above that I do think HMI may have an outside shot at approval in 3 years assuming the FDA can use the China Phase 2 trial (it is listed as a trial location on clinical. trials.gov). HMI is accumulating a sizeable safety record if you include Phase 2 for endometriosis), and further assuming that they can demonstrate some positive results. I would be ecstatic if it were approved. I can’t tell you how many times I have said to myself that my hair may not look great but its a hell of a lot better than it will look in another year, or I wonder how bad it will look 6 months from now……………I would love to get that mental monkey off my back………..that is the upside of maintenance for me.
On a related note, Cutia Therapeutics completed Phase 1 trials in 2023 for CU-40101. This drug candidate is a topical small molecule thyroid hormone receptor agonist,
https://in.marketscreener.com/quote/stock/CUTIA-THERAPEUTICS-155368747/news/Cutia-Therapeutics-Announces-Phase-I-Clinical-Trial-of-CU-40101-Topical-Small-Molecule-Thyroid-Horm-44718692/
The press release is from August 2023…I hope they start with phase 2 soon?
Paus, Technoderma and Cutia – the thyroid pathway is obviously worth to pursue!
‘completed phase 1 trials’
Thanks, changed.