Chinese biopharmaceutical company Technoderma Medicines has reported data from a Phase IIa clinical trial of its small molecule drug candidate TDM-105795, a topical solution designed to treat androgenetic alopecia.
The randomised, double-blind trial included daily dosing over four months and aimed to assess the topical solution’s initial efficacy, pharmacokinetics and safety.
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It enrolled 71 male participants across 13 clinical sites in the US, who were then randomised into a 1:1:1 ratio.
The results indicated that TDM-105795 led to a mean increase in non-vellus Target Area Hair Count (TAHC) of 24.3 hairs with the high label strength (0.02%) and 20.3 hairs with the low label strength (0.0025%), compared with a 14 hair increase with the placebo.
Both tested concentrations of TDM-105795 were well-tolerated in the subjects without any significant safety concerns detected.
Bioanalytical data revealed minimal to no systemic exposure following the once-daily application of the topical solution.
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By GlobalDataThe preclinical assessment of TDM-105795 showed that it is likely to avoid systemic effects due to its low systemic absorption and reduced elimination half-life when applied topically.
In-vivo studies of the drug demonstrated that it could effectively stimulate hair growth in a dose-dependent manner in C3H mice.
TDM-105795’s mechanism of action involves activating dormant hair follicle stem cells and inducing the anagen phase in hair follicles, which is supported by its ability to bind to specific proteins in hair follicle cells.
Technoderma Medicines chief medical officer Arthur Bertolino said: “We are excited to see that TDM-105795 in the current Phase II testing has demonstrated hair growth in androgenetic alopecia with a very favourable safety profile.
“We look forward to moving the clinical programme forward to better assess how longer-term treatment is able to provide global improvement in hair coverage.”
In December 2023, Technoderma Medicines concluded a Phase I clinical trial of TDM-180935 topical ointment for the treatment of atopic dermatitis.
