TDM-105795 Phase 2 Success: Stimulates Hair Growth in Pattern Baldness

Technoderma Medicines, a biopharmaceutical firm in the clinical stage, has announced the successful completion of its Phase 2a clinical trial for TDM-105795, a topical solution aimed at treating Androgenetic Alopecia (AGA), commonly known as male or female pattern baldness. The study, titled "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," involved daily application for four months across thirteen clinical sites in the U.S.

The trial's primary goals were to assess the preliminary efficacy, safety, and pharmacokinetics of TDM-105795. It featured a 1:1:1 randomization with 71 enrolled patients. The results indicated a significant increase in non-vellus Target Area Hair Count (TAHC) from baseline, with the high-strength (0.02%) and low-strength (0.0025%) formulations showing an average increase of 24.3 and 20.3 hairs per cm2, respectively, compared to the placebo's 14.0 hairs. Both strengths were found to be well-tolerated, with no significant safety concerns.

Dr. Arthur P. Bertolino, Technoderma's Chief Medical Officer, expressed enthusiasm for the compound's performance, highlighting its favorable safety profile and the potential for long-term treatment to improve overall hair coverage. Zengquan Wang, the company's CEO, noted the milestone's significance in bolstering confidence in their pipeline's ability to develop clinically beneficial new chemical entities in dermatology.

TDM-105795 is a small molecule with thyromimetic properties, offering potential advantages in efficacy and safety over current treatments. Preclinical studies suggest minimal systemic absorption post-application and a brief elimination half-life, reducing the risk of unwanted systemic effects. In vivo tests on mice demonstrated TDM-105795's ability to stimulate hair growth in a dose-dependent manner, likely due to its activation of dormant hair follicle stem cells and its induction of the growth phase in resting hair follicles. Phase 1 clinical trials confirmed its safety and tolerability, with the Phase 2 results further supporting its development.

AGA is a prevalent hair loss condition affecting both genders, with a higher prevalence in men. It is characterized by a receding hairline and baldness in men, and thinning hair density in women. The condition's etiology is not fully understood but may involve genetic and hormonal factors. The development of TDM-105795 is part of Technoderma's broader commitment to creating innovative dermatological therapies, including treatments for Atopic Dermatitis, Psoriasis, and Lupus Erythematosus. The company, which has recently moved to Chengdu Tianfu BioPark, is privately held and focuses on advancing its "first-in-class" drug candidates.