Technoderma Medicines, Inc.
a clinical stage biopharmaceutical company, is pleased to report that the Company has completed its Phase 2a clinical trial (NCT05802173) of TDM-105795 topical solution for Androgenetic Alopecia (AGA). This Proof-of-Concept clinical trial in the AGA program included daily dosing for four months in a study entitled, "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". Study objectives were to evaluate preliminary efficacy, safety and pharmacokinetics of topical TDM-105795; thirteen U.S. clinical sites participated in this study under an open IND with FDA. Evaluation of efficacy by measurement of non-vellus Target Area Hair Count (TAHC) showed mean changes from baseline of 24.3 hairs with the high label strength (0.02%) and 20.3 hairs with the low label strength (0.0025%) topical solution, compared to 14.0 hairs with placebo in 1 cm2 test areas; randomization was 1:1:1 with 71 patients enrolled. Both label strengths of TDM-105795 were well tolerated with no material safety issues identified. Bioanalytical results show that once daily application of TDM-105795 topical solution at either dose produced extremely low to no systemic exposure.
Arthur P. Bertolino, MD, PhD, MBA, Chief Medical Officer at Technoderma Medicines commented, "We are excited to see that TDM-105795 in the current Phase 2 testing has demonstrated hair growth in AGA with a very favorable safety profile. We look forward to moving the clinical program forward to better assess how longer-term treatment is able to provide global improvement in hair coverage."
"This is another major milestone for the Company that further increases confidence in our pipeline programs to produce and develop clinically useful new chemical entities in dermatology," said Zengquan Wang, PhD, Chief Executive Officer at Technoderma Medicines. "We are committed to developing a portfolio of innovative dermatology drug candidates."
About TDM-105795
TDM-105795 is a small molecule drug candidate being developed as a topical drug for treatment of Androgenetic Alopecia. As a potent thyromimetic, it may offer significant advantages regarding efficacy and safety compared to existing treatments. Preclinical assessment of TDM-105795 indicates that it has poor systemic absorption following topical application and a short elimination half-life, features well-suited to avoid unwanted systemic effects. Moreover, in vivo efficacy studies in C3H mice showed that TDM-105795 was able to potently stimulate hair growth in a dose-dependent manner when applied topically. This is likely because TDM-105795 is able to activate dormant hair follicle stem cells and induce anagen (growth phase) in telogen (resting phase) hair follicles when binding to hair follicle cell target receptor proteins. Testing in rats and minipigs demonstrated favorable toxicology and toxicokinetic profiles. Phase 1 clinical testing showed it to have a favorable safety profile and to be well-tolerated. The response of hair growth observed in Phase 2 AGA clinical testing together with a continued favorable safety profile with longer treatment anchors further development.
About Androgenetic Alopecia (AGA)
Androgenetic Alopecia (AGA), also called male or female pattern baldness, is the most common hair loss condition affecting both men and women, with a higher incidence in men. While more than half of adult males suffer from AGA, this rate increases to 80% in men at age 50 and above. Male AGA is characterized by receding hairline and baldness on the top and front of the head. Female AGA is usually manifested as hair density thinning on the top and crown of the head. As a degenerative disorder with etiology largely unknown, genetic, psychological and mental, endocrinologic and metabolic factors may play a role. The pathogenesis underlying AGA has been linked to hyperactivation of androgen receptors in hair follicle cells, rendering resting hair follicles unable to re-enter the growth phase and undergoing miniaturization.
About Technoderma Medicines
Technoderma Medicines, Inc. is a privately held clinical stage biopharmaceutical company. The Company was originally located in Jiaxing Xiuzhou Biomedicine Guoqian Park, China, and recently relocated to Chengdu Tianfu BioPark, Sichuan, China. Its current core programs focus on development of innovative therapies for Androgenetic Alopecia, Atopic Dermatitis, Psoriasis and Lupus Erythematosus. Its "first-in-class" small molecule thyromimetic drug candidate TDM-105795 for Androgenetic Alopecia has now successfully completed Phase 2a clinical testing. Technoderma's novel JAK1/TYK2 inhibitor TDM-180935 for Atopic Dermatitis has recently completed Phase 1 clinical testing with a favorable safety profile. The pipeline targets dermatologic indications.