Technoderma Medicines, Inc. (“the Company”), a clinical stage biopharmaceutical company, is pleased to report the Company has begun dosing in its Phase 1b （MAD）clinical trial of topical TDM-105795 solution in patients with Androgenetic Alopecia (AGA). This second clinical trial in the program is a 28-day multiple dose escalation study entitled, “A Randomized, Double-Blind, Vehicle-Controlled, Parallel Group, Multi-Dose Escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of TDM-105795 in Healthy Male Subjects with Androgenetic Alopecia”. Study objectives are to evaluate the safety and pharmacokinetics of topical TDM-105795 following repeated doses. Two U.S. clinical sites are currently participating in this study. —
Arthur P. Bertolino, MD, PhD, MBA, Chief Medical Officer at Technoderma Medicines commented, “We also expect the current study results to guide choice of formulation strength(s) appropriate for a subsequent proof-of-concept (PoC) Phase 2 Androgenetic Alopecia study. The Company anticipates the robust induction of hair growth demonstrated by TDM-105795 in preclinical testing should be observable within several months of initiating treatment.”
“We look to the TDM-105795 AGA program as the first clinical anchor among our pipeline products for treatment of various dermatologic diseases,” said Zengquan Wang, Chief Executive Officer at Technoderma Medicines. “We are working to bring a second pipeline product (Atopic Dermatitis) into clinical testing soon in mid-year.”
TDM 105795 is a small molecule drug candidate being developed as a topical drug to promote hair growth. Preclinical assessment of TDM 105795 indicates that TDM 105795 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.
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，Inc.
Technoderma Medicines, Inc. is a privately held clinical stage biopharmaceutical company located in Jiaxing Xiuzhou Biomedicine Guoqian Park. 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 drug candidate TDM-105795 for Androgenetic Alopecia is currently undergoing clinical testing. Technoderma’s JAK1/TYK2 inhibitor for Atopic Dermatitis is completing late-stage preclinical testing and it has a target IND filing date in mid-year 2022. The pipeline targets dermatologic indications.
Release ID: 89065299