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Technoderma Medicines Initiates TDM-105795 Androgenetic Alopecia Phase 2 Clinical Trial

CHENGDU, China, April 18, 2023. Technoderma Medicines, Inc. ("the Company"), a clinical stage biopharmaceutical company, is pleased to report that the Company has begun dosing patients in its Androgenetic Alopecia (AGA) Phase 2 clinical trial (NCT05802173) of topical TDM-105795 solution. This clinical trial in the AGA program includes 16 weeks dosing of two different active formulation strengths and placebo 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 are to evaluate efficacy, safety and pharmacokinetics of topical TDM-105795. Approximately 12 U.S. clinical sites are currently participating in this study under an open IND with FDA.

Arthur P. Bertolino, MD, PhD, MBA, Chief Medical Officer at Technoderma Medicines commented, "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 program."

"Transition into a Phase 2 study with this lead clinical program is a major milestone for the Company. We have assets in multiple phases of clinical development and anticipate bringing other preclinical pipeline products to clinical testing in subsequent years," said Zengquan Wang, Chief Executive Officer at Technoderma Medicines. "We have demonstrated that the Company can sustainably produce a robust portfolio of 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.

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 Biomed Town, Chengdu, Sichuan Province, 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 is currently in Phase 2a clinical testing. Technoderma's novel JAK1/TYK2 inhibitor TDM-180935 for Atopic Dermatitis is now in Phase 1 clinical testing. The pipeline targets dermatologic indications.

SOURCE Technoderma Medicines

Posted: April 2023

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