Technoderma Medicines Advances TDM-105795 into Phase Ib Clinical Trial for Androgenetic Alopecia

As the pace of modern life accelerates and work-related stress intensifies, hair loss has become a new-era “epidemic,” affecting people regardless of age or gender.

Previously, survey data released by the National Health Commission of China showed that by the end of 2020, the number of people suffering from hair loss in China had exceeded 252 million, accounting for as high as 18% of the total population. Among this vast population with hair loss, those with androgenetic alopecia constitute the largest group, representing over 90%. In other words, more than 220 million people in China suffer from androgenetic alopecia. Hair loss is particularly prevalent in Western countries; according to a survey report by the American Hair Loss Association, two-thirds of American men experience hair loss by age 35, and the prevalence among men around age 50 can exceed 80%. There is broad market potential for hair loss treatment medications, and there is a need for safer and more effective hair regrowth products.

To address the concerns of individuals suffering from hair loss, the biomedical community is making continuous efforts to develop innovative drugs that can fundamentally resolve androgenetic alopecia.

Jiaxing Tkeluo Biotechnology Co., Ltd. (hereinafter referred to as “Tkeluo,” www.tkskin.com), an innovative pharmaceutical company focused on dermatological indications, recently announced that clinical sites in the United States have begun enrolling patients with androgenetic alopecia (AGA) for a Phase Ib clinical trial of its topical agent TDM-105795. This development holds promise for providing new treatment options and benefiting patients with hair loss.

“There is a genuine need for effective and safe treatments for androgenetic alopecia.” According to Dr. Arthur P. Bertolino, Chief Medical Officer at Tecro, TDM-105795 demonstrated favorable safety and tolerability in its first clinical trial, while preclinical data also showed that it efficiently induces hair growth in animal models. “The company is highly encouraged by the results of the Phase I clinical trial.”

It is reported that, at present, small-molecule drugs for androgenetic alopecia have attracted little interest. Only two drugs, minoxidil and finasteride, have been approved by the U.S. FDA for the treatment of hair loss.

Unlike the mechanisms of action of the two aforementioned drugs, TDM-105795 binds to target proteins within hair follicle cells, thereby activating dormant hair follicle stem cells. This induces hair follicles in the telogen phase to enter the anagen phase, prolongs the anagen phase, and shortens both the catagen and telogen phases, ultimately achieving therapeutic effects for hair loss.

It is reported that TDM-105795 is a small-molecule drug for the treatment of androgenetic alopecia, featuring global intellectual property protection and international leading status. Data from completed animal studies indicate that TDM-105795 has a rapid onset of action, with significant hair growth observed within 3–5 days after administration, and the entire hair growth cycle can be completed within 15–18 days. Topical application potently stimulates hair growth in a dose-dependent manner. Furthermore, preclinical studies have demonstrated that topical administration of TDM-105795 results in minimal systemic exposure and a short plasma elimination half-life, thereby effectively avoiding unwanted systemic effects.

Previously, the Investigational New Drug (IND) application for this drug (IND154722) was approved by the U.S. FDA, and Phase I clinical trials were immediately initiated in the United States.

Latest updates indicate that Tecro has announced the initiation of patient recruitment for a Phase Ib clinical trial of TDM-105795 in individuals with androgenetic alopecia (AGA) at clinical sites in the United States. This advancement follows the successful completion of a single-ascending-dose Phase Ia clinical trial (NCT04913519). According to reports on adverse events, local skin reactions, and changes from baseline in vital signs, safety laboratory parameters, and electrocardiograms following dosing, no safety concerns requiring special attention were identified during the Phase Ia study of TDM-105795.

According to reports, the Phase Ib clinical trial, titled “A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of TDM-105795 in Healthy Male Patients with Androgenetic Alopecia (AGA),” is a 28-day multiple ascending dose study. It aims to assess the safety, tolerability, and pharmacokinetic parameters of repeated topical administration of TDM-105795, thereby determining the optimal formulation concentration for Phase II clinical trials designed to validate efficacy.

A previous research report by Huatai Securities indicated that China’s hair loss diagnosis and treatment market was valued at nearly RMB 20 billion in 2020, with pharmaceuticals accounting for approximately RMB 700 million. The firm projects a compound annual growth rate (CAGR) of over 20% for this market in the coming decade, with the domestic market size for hair loss drug treatments expected to reach RMB 15.5 billion by 2031. Furthermore, Tecro, holding an innovative small-molecule drug for the treatment of androgenetic alopecia, is poised to enter a blue ocean market, leveraging the substantial patient population and market potential in Europe and the United States.

“We are excited about the clinical progress achieved by our TDM-105795 program for the treatment of androgenetic alopecia (AGA), and we look forward to advancing other pipeline compounds targeting various dermatological conditions into clinical trials in a similar manner. We hope to make significant contributions to addressing the market needs in this therapeutic area,” said Dr. Wang Zengquan, CEO of Tecro.

Public information indicates that Techro is an innovative small-molecule drug R&D company focused on the development of novel therapeutics for dermatological conditions. The company is committed to becoming a world-leading platform for the research and development of new dermatology drugs, aiming to bring to market global first-in-class or best-in-class therapies targeting major skin-related diseases. It seeks to provide patients worldwide with more effective, safer, and cost-efficient novel drug products based on entirely new mechanisms of action.

Currently, Tecro has built a pipeline of first-in-class or best-in-class drug candidates for androgenetic alopecia as well as autoimmune and inflammatory skin diseases. TDM-105795 is the flagship product of Tecro’s hair growth program and represents the company’s most advanced development pipeline.

In the field of inflammatory skin diseases, the company is dedicated to advancing the research and development of highly differentiated innovative small-molecule JAK inhibitors tailored to specific dermatological conditions. It has already established a robust intellectual property portfolio, with multiple series of compounds exhibiting distinct differentiation and competitive advantages being simultaneously developed for eczema, psoriasis, lupus erythematosus, and other diseases.

Among these, preliminary efficacy results for the eczema program indicate that the candidate drug demonstrates a significant therapeutic advantage, with greater potency than marketed PDE4 inhibitors and comparable efficacy to glucocorticoids but without their adverse cutaneous side effects. The eczema program is expected to file for Phase I clinical trials in the second quarter of 2022. The company’s new drug candidates for psoriasis and lupus erythematosus are also progressively entering the stage of filing for clinical trials.

SHANGHAI – January 5, 2022  Technoderma Medicines, Inc. (“the Company”), a clinical stage biopharmaceutical company, is pleased to report the Company has begun recruitment for its second Phase 1 clinical trial of topical TDM-105795 in patients with Androgenetic Alopecia (AGA). This follows successful completion of a single dose escalation study (NCT04913519) in which no material clinical safety issues were demonstrated based on reporting of adverse events, local skin reactions and changes from baseline in vital signs, safety labs, and ECG.

This second clinical trial 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”. Its objectives are to evaluate topical TDM-105795 repeated dose safety and toleration and its pharmacokinetics, in order to define formulation strength(s) appropriate for a proof-of-concept Phase 2 study planned to follow.

“There is a real current need for effective and safe medical options to treat Androgenetic Alopecia,” said Arthur P. Bertolino, MD, PhD, MBA, Chief Medical Officer at Technoderma Medicines. “The Company is encouraged by TDM-105795 safety and toleration demonstrated in its first clinical trial and by preclinical data showing robust induction of hair growth in an animal model.”

Dr. Zengquan Wang, Chief Executive Officer at Technoderma Medicines commented, “We are excited about the progress being made with the TDM-105795 AGA program advancing in the clinic. In addition, we look forward to additional pipeline compounds likewise following into the clinic for treatment of various dermatologic diseases. We hope to contribute significantly to addressing the market need in this therapy area.”

About TDM-105795

TDM105795 is a small molecule drug candidate being developed as a topical drug to promote hair growth. Preclinical assessment of TDM105795 indicates that TDM105795 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 TDM105795 was able to potently stimulate hair growth in a dose-dependent manner when applied topically. This is likely because TDM105795 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.

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.

Technoderma Medicines, Inc. is a privately held clinical stage biopharmaceutical company located in Jiaxing Xiuzhou Biomedicine Guoqian Park, Shanghai. Its current core programs focus on development of innovative therapies for Androgenetic Alopecia, Atopic Dermatitis, Lupus Erythematosus and Psoriasis. 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.