Technoderma Medicines Inc. Successfully Completes Phase 2a Clinical Trial
Interesting news from Technoderma Medicines Inc. about their Phase 2a trial.
TDM-105795: Positive Results Observed Compared to Baseline
Technoderma Medicines Inc. has completed a Phase 2a clinical trial for TDM-105795, “A Randomized, Double-Blind, Vehicle Controlled, Parallel Group, Multi-Dose Study to Evaluate the Efficacy and Safety of TDM-105795 in Male Subjects with Androgenetic Alopecia.”
TDM-105795 is a topical solution to treat androgenic alopecia (AGA). The trial demonstrated significant increases in total area hair count (TAHC) versus baseline for both low- and high-dose formulations of the topical solution.
Details and results of the completed trial are as follows (as reported through a Press Release):
- The study included 71 male participants with mild to moderate androgenetic alopecia (AGA) in the temple and vertex region, scoring 3v, 4, or 5 on the modified Norwood-Hamilton Scale.
- Participants were randomized 1:1:1 into 3 groups: low dose (0.0025%), high dose (0.02%), and a placebo group.
- The treatment was applied once daily for 16 weeks.
- Mean non-vellus target area hair count (TAHC) was measured at baseline and endline in a 1cm2 test area.
- The TAHC changed from baseline by 24.3 hairs with the 0.02% treatment dose.
- The TAHC changed from baseline by 20.3 hairs with the 0.0025% treatment dose.
- The TAHC changed from baseline by 14 hairs with the placebo treatment.
- Both treatment strengths were also reported to be well tolerated, with no safety issues found and very little to no systemic exposure.
What is TDM-105795?
TDM-105795 is a drug that mimics the effects of thyroid hormones. It is being developed as a potential topical treatment for AGA. TDM-105795 has shown encouraging results in both preclinical and early clinical trials. Its suspected mechanism of action includes stimulating hair growth by activating dormant hair follicle stem cells and inducing the growth phase of hair follicles. According to reports so far, it has minimal systemic absorption and a favorable safety profile.
Reflections
Follicle Thought has mentioned TDM-105795 in its previous alopecia research pipeline summaries, here and here. It’s always encouraging to see the advancement of a novel therapeutic candidate for AGA. However, veterans of the hair loss community will know to temper expectations from phase 2a clinical trials and, particularly, from company-issued press releases.
Importantly, there are questions that this press release has yet to answer.
1. Did TDM-105795 statistically significantly increase TAHC versus placebo?
In the absolutes, participants applying the low- and high-strength TDM-105795 formulations saw an increase in TAHC versus placebo. This is encouraging, particularly given that mean TAHC increased in TDM-105795 groups in a dose-dependent manner. But for a smaller clinical trial that included just 71 participants split across 3 groups, there’s also a likelihood that these results are explainable through chance. Statistical testing helps to control for this risk. To our knowledge, no statistical testing was mentioned in the press release.
2. What is the distribution of TAHC across participants in all three groups?
While the press release references mean TAHC across groups, we do not know the distributions of TAHC across participants or groups. If TAHC distributions follow a bell curve pattern across all groups, this would be a positive signal. However, if distributions show that mean TAHC in the TDM-105795 groups are driven not by average participant responses but by a small number of hyper-responders, this would suggest the novel compound only helped a small portion of participants, while the majority of participants saw no response.
With the publication of these results in a peer-reviewed journal, we’ll have more information.
Let us know what you think in the comments.
Posted in Hair Growth Treatment, TechnoDerma Medicines Inc.
It’s good news….but as always, the most forgotten are women. I don’t understand why they are so reluctant to try them. This is an increasingly present problem in girls. Although I understand that if the pathway is the activation of follicular stem cells, it should also work in women.
It is almost difficult to belive how little is done to also find new treatment for women, consider how large impact hair loss can potentionally can have on womens mental health, and also how desperate a lot of them are to find “solutions”. I wish this problem was taken more serious! Also as you are noting, hair loss for young women is defenetly an increasing problem!
Because in men the causes are known quite well, for example in men it is known that the main problem is the conversion of testosterone into driitosterone which can bind to the AR receptor of the hair and this causes hair loss, in women the situation Unfortunately it is more complex.
That is why we need more reasearch behind the reasons why, so we are also able to find solutions for women!
There are more options for women that can be done as compared to males with Androgenetic alopecia we have limited options and not a huge success. I know they can try hormones possibly? on women and biotin and some other options although this could also help women as well though. There will definitely have to be more studies done on women as well so I would hold on to hope as there’s sure to be something in the near future for women as well as men with Androgenetic alopecia
Me he equivocado, la vía es a través de los receptores tiroideos….
This is an English site compadre
Relevance? He’s on topic and you’re not
Hello admin! This looks good! (at least for now). However do you think that this product’s mechanism will be effective for long term use? (as compared, for example, to minoxidil, which becomes less effective as more genes are expressed in the scalp as you age)
Is this the same mechanism of action as people use use topical zinc-thymulin? I’ve been using it with some success for several months.
As my career as a provider of hair loss solutions cratered when a hair transplant surgeon wrongly attempted an HR in the presence of alopecia areata, I can only dream I might recover my sense of self assurance ,should a cure for hair loss arrives, I will watch with great interest as these trials continue.
John Vincent
Author of Hair Loss Dossier (on Amazon)
Cutia Therapeutics CU-40101 appears to just be in-licensed TDM-105795 from TechnoDerma, so the same drug. I don’t see this information on your site or elsewhere that these are the same and trial results keep getting reported separately
“We in-licensed from TechnoDerma Medicines Inc., an Independent Third Party, in May 2020 an exclusive, royalty-bearing, and assignable license to develop, manufacture and
commercialize CU-40101 in Asia for dermatology indication of hair growth”
from: https://www1.hkexnews.hk/listedco/listconews/sehk/2023/0531/2023053100049.pdf