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.