Technoderma Medicines Initiates Phase 1b (MAD) Clinical Trial of TDM-105795 for Androgenetic Alopecia
On February 28, 2022, Jiaxing Tekelo Biotechnology Co., Ltd. (hereinafter referred to as “Tekelo”) announced that the enrollment of all patients in the first dose cohort of its Phase 1b multiple ascending dose (MAD) clinical trial for TDM-105795 tincture, a topical medication for patients with androgenetic alopecia (AGA), was completed in the United States on February 23, and patient dosing has commenced. Tekelo is a biopharmaceutical company dedicated to the research and development of novel dermatological drugs.
The Phase 1b clinical trial is a 28-day multiple ascending dose study. This clinical study is a “randomized, double-blind, vehicle-controlled, parallel-group, multiple ascending dose study to evaluate the safety, tolerability, and pharmacokinetics of TDM-105795 in healthy male subjects with androgenetic alopecia.” Currently, two U.S. clinical centers are participating in this study.
Arthur P. Bertolino, Chief Medical Officer at Tekelo Biosciences, expressed high expectations for the clinical trials of TDM-105795: “We anticipate that the results from the current clinical study will guide our selection of the appropriate formulation concentration and dosage for subsequent Phase II clinical trials, which aim to validate the proof of concept (PoC) for the treatment of androgenetic alopecia. We expect to observe the hair growth-promoting effects of TDM-105795, as demonstrated in preclinical studies, within a few months of patient treatment.”
Dr. Wang Zengquan, CEO of Teco Bio, expressed strong confidence in the company’s development, stating, “TDM-105795, our therapeutic candidate for androgenetic alopecia, is the first blockbuster clinical-stage drug in Teco’s pipeline for various dermatological conditions. The company is striving to advance its second pipeline product, targeting eczema/atopic dermatitis, into clinical studies by mid-year.”
TDM-105795 is a small-molecule candidate drug designed as a topical agent to promote hair growth. Preclinical evaluations of TDM-105795 have demonstrated poor systemic absorption and a short elimination half-life following topical administration, characteristics that are highly advantageous for minimizing unnecessary systemic effects. Furthermore, in vivo efficacy studies in C3H mice have shown that topical application of TDM-105795 promotes hair growth in a dose-dependent manner. This effect may be attributed to the ability of TDM-105795 to activate dormant hair follicle stem cells upon binding to target receptor proteins in hair follicle cells, thereby accelerating the transition of hair follicles from the telogen (resting) phase to the anagen (growth) phase.
Androgenetic Alopecia (AGA), also known as male- or female-pattern baldness, is the most common form of hair loss affecting both men and women, with a higher prevalence in men. More than half of adult men suffer from AGA, and this proportion can rise to over 80% among men aged 50 and older. Male AGA is characterized by a receding hairline and balding at the crown and frontal scalp. Female AGA typically presents as diffuse thinning of hair on the vertex. The etiology of hair loss remains poorly understood; as a degenerative condition, it may be triggered by genetic, psychological, mental, endocrine, and metabolic factors. The pathogenesis of AGA is associated with the overactivation of androgen receptors in hair follicle cells, which prevents resting follicles from re-entering the anagen (growth) phase, leading to follicular miniaturization.
Tecro Biotech Co., Ltd. is a privately held, clinical-stage biopharmaceutical R&D company headquartered in the Jiaxing Xiuzhou National Thousand Talents Program Bio-medicine Park. The company’s current core projects focus on developing innovative therapies for androgenetic alopecia, eczema/atopic dermatitis, psoriasis, and lupus erythematosus. Its globally leading small-molecule candidate, TDM-105795, for the treatment of androgenetic alopecia, is currently undergoing clinical trials. A JAK1/TYK2 inhibitor targeting eczema/atopic dermatitis is completing late-stage preclinical testing, with an Investigational New Drug (IND) application expected to be submitted by mid-year. Tecro’s drug development pipeline primarily targets multiple dermatological indications.
The full English text is attached below.
SHANGHAI – February 28 2022 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.”