Technoderma Medicines has started dosing patients in a Phase II study of topical TDM-105795 solution for the treatment of androgenetic alopecia (AGA).
The multi-dose, vehicle-controlled, parallel group, double-blind, randomised study will enrol male subjects with AGA.
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The study will assess the safety, efficacy and pharmacokinetics of two different active formulation strengths of TDM-105795 for 16 weeks against a placebo.
Technoderma Medicines CEO Zengquan Wang said: “We have assets in multiple phases of clinical development and anticipate bringing other preclinical pipeline products to clinical testing in subsequent years.
“We have demonstrated that the company can sustainably produce a robust portfolio of dermatology drug candidates.”
Participants for the study are selected from nearly 12 US sites, under an open IND with FDA.
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By GlobalDataTechnoderma Medicines chief medical officer Arthur Bertolino said: “We expect the current study design to support proof-of-concept regarding hair growth efficacy and to guide choice of formulation strength(s) appropriate for late stage clinical development.
“Observation of meaningful quantitative data regarding hair counts and global photographic assessments of hair growth will enable us to anchor the programme.”
Apart from the AGA programme, the company is involved in other programmes for developing new therapies for atopic dermatitis, psoriasis and lupus erythematosus.
The company’s Phase IIa trial of TDM-105795 for AGA is also underway. In addition, the company is testing JAK1/TYK2 inhibitor TDM-180935 for atopic dermatitis in a Phase I study.
