Technoderma Bioscience Announces First-in-Human Dosing of TDM-105795, a Novel Small Molecule for Androgenetic Alopecia, in U.S. Phase I Clinical Trial

Recently, Jiaxing Technoderma Biotechnology Co., Ltd. (www.tkskin.com) announced the successful completion of first-in-human (FIH) dosing in healthy male subjects with androgenetic alopecia (AGA) in the Phase I clinical trial of its globally leading small-molecule drug, TDM-105795, at Therapeutics Clinical Research (TCR), a dermatology clinical research center in San Diego, Western United States.

TDM-105795It is a small-molecule drug with global intellectual property protection and international leading status for the treatment of androgenetic alopecia. The Investigational New Drug application (IND154722) for this drug received implicit approval from the U.S. FDA, allowing it to immediately enter Phase I clinical trials in the United States. This Phase I clinical study employs a multicenter, randomized, double-blind, vehicle-controlled, parallel-group, dose-escalation design to evaluate the safety, tolerability, and pharmacokinetics of TDM-105795 following a single topical administration of fixed volume in healthy male subjects with androgenetic alopecia (AGA).

Currently, the Phase I clinical trial of TDM-105795 has completed subject screening, enrollment, and dosing of the first two subjects. The dose-escalation phase of the Phase I clinical trial is expected to be completed in approximately three months.

Dr. Wang Zengquan, Founder, General Manager, and Chief Scientist of Technoderma Medicines, Inc.“He stated, ‘We are delighted that our first independently developed, internationally leading “First-in-Class” small-molecule drug, TDM-105795, for the treatment of androgenetic alopecia, has received approval from the U.S. FDA to enter Phase I clinical trials and that the first subject has been dosed. This marks a significant turning point for the company, transitioning from preclinical to clinical research. The entry into clinical trials of this original small-molecule drug, featuring a novel mechanism of action and a new indication, preliminarily demonstrates our innovative capabilities in the field of new dermatological drug development. It also represents a significant milestone in the development of innovative therapies for androgenetic alopecia. We hope that subsequent clinical development will ultimately lead to the drug’s market approval, providing patients with hair loss a new therapeutic option and delivering tangible benefits. Technoderma Medicines will continue to advance novel drugs for other dermatological indications into clinical development, striving to develop affordable, safe, and effective medications for patients with skin diseases. On this occasion, I would like to express my gratitude to our R&D team for their tireless efforts, to the new and existing fund investors and friends who have supported the company since its inception, and to the many partner companies for their sincere collaboration on this project. We look forward to your continued support for the company’s future development!’”

Dr. John Mao, Director of Technoderma Medicines, Inc. and Chief Research Advisor for Project R&D“He stated, ‘I am delighted to participate in and guide the research and development of this project. The development of innovative dermatological drugs is highly complex. Dr. Wang Zengquan possesses extensive expertise and experience in the field of new drug development for dermatological conditions. The management team at Technoderma Medicines, Inc. has rich experience in skin and drug R&D, and the company maintains strong collaborative relationships with both domestic and international CROs. The project has also received support from numerous companies. Typically, preclinical research for new topical dermatological drugs is relatively complex and time-consuming; however, clinical development costs are lower, and the clinical trial timeline is significantly shorter. I hope that the subsequent development of this drug proceeds smoothly, ultimately bringing new treatment options and benefits to patients suffering from hair loss.’”

Regarding the clinical research for this project, Dan Piacquadio, MD, CEO of a clinical research organization (CRO) in San Diego, California, USA, stated: “We are proud to collaborate with Technoderma on the clinical study of TDM-105795 for the treatment of androgenetic alopecia. This Phase I clinical study is a landmark first-in-human trial that will begin to lay the foundation for the clinical advancement of this novel, cutting-edge technology. We are pleased that Technoderma is undertaking important clinical research, utilizing innovative new drugs to address unmet therapeutic needs in significant or rare dermatological indications. It is an honor to conduct the clinical trials of TDM-105795 under the company’s guidance. We hope for a successful and smooth clinical trial.”

Androgenetic alopecia (AGA), also known as seborrheic alopecia or simply male/female pattern baldness, is a condition characterized by progressive hair loss that occurs during and after puberty.In men, the condition primarily manifests as recession of the frontal hairline and/or progressive thinning and miniaturization of hair on the vertex, also known as male pattern hair loss. In women, hair loss mainly presents as progressive thinning and miniaturization of hair on the vertex; a minority of cases exhibit diffuse hair thinning without recession of the hairline, termed female pattern alopecia. The prevalence of this condition varies significantly among different ethnic groups, being higher in Caucasians and lower in African Americans and Asians. Approximately 30% of Caucasian men experience hair loss by age 30, with the prevalence exceeding 50% by around age 50, and more than 80% affected by around age 70. About 40–50% of Caucasian women are affected by androgenetic alopecia during their lifetime, with the impact of hair loss increasing with age.

Currently, there are only two FDA-approved products for the treatment of hair loss: “Rogaine” (Minoxidil) and “Propecia” (Finasteride).However, these two medications have a slow onset of action, suboptimal efficacy, prolonged treatment courses, and adverse side effects, resulting in limited patient benefit. Patients with hair loss are eager for more affordable, safe, and effective therapeutic products.

Technoderma Medicines, Inc. is an innovative company dedicated to the research and development of novel small-molecule drugs for topical treatment of dermatological conditions. Its management team possesses extensive experience in dermatology and drug development, supported by a robust network of external scientific advisors and internal shareholder resources comprising experts from the biopharmaceutical industry.The core members of the company’s management-level new drug R&D team include Dr. Wang Zengquan (an expert in skin biology, autoimmune diseases, and dermatological drug development), Dr. Li Guanqun (a Ph.D. in clinical dermatology, biologist, and expert in early-stage drug development), and Dr. Fang Wenkui (Ph.D. in Organic Chemistry from the University of Michigan, senior medicinal chemist, and expert in the development of topical medications for skin and ophthalmic diseases). All three doctors graduated from prestigious universities, pursued advanced studies abroad for many years, and have extensive work experience at internationally renowned pharmaceutical companies. They are heavyweight experts in the field of dermatological research and have been recognized as “Leading Talents” by Jiaxing City, Zhejiang Province.

Technoderma Medicines, Inc. currently has a product portfolio that includes treatments for hair loss, dermatitis, psoriasis, and lupus erythematosus.Technoderma’s first clinical research project is TDM-105795, a “first-in-class” small-molecule drug for the treatment of seborrheic alopecia, which is protected by global intellectual property rights. Furthermore,In the new drug development pipeline, the programs for treating psoriasis and dermatitis have entered CMC and preclinical studies. The atopic dermatitis/eczema program is expected to file for Phase I clinical trials in early 2022, while the psoriasis program is anticipated to apply for Phase I clinical trials by the end of 2022.Technoderma has positioned its highly selective non-receptor tyrosine kinase Tyk2 inhibitor candidate for the treatment of systemic lupus erythematosus and other autoimmune-related skin diseases, while simultaneously expanding into additional indications to broaden its drug development pipeline.