Technoderma Medicines Completes Phase 1 Dose Escalation Clinical Trial of TDM-180935 for Atopic Dermatitis

Technoderma Medicines, Inc. a clinical stage biopharmaceutical company, is pleased to report that the Company has completed a Phase 1 clinical trial (NCT05525468) of TDM-180935 topical ointment for Atopic Dermatitis (AD). This first clinical trial in the AD program included single dose and multidose escalation cohorts in a study entitled, "A Randomized, Double-Blind, Vehicle-Controlled, Parallel Group, Dose Escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of TDM-180935 Following Topical Administration in Healthy Male Subjects". Study objectives were to evaluate safety and pharmacokinetics of topical TDM-180935; one U.S. clinical site participated in this study under an open IND with FDA. All strengths of TDM-180935 (0.25%-2.0%) were well tolerated with no material safety issues identified. Bioanalytical results show that once daily application of TDM-180935 for 4 weeks over the range of doses studied produces extremely low to no systemic exposure.

Arthur P. Bertolino, MD, PhD, MBA, Chief Medical Officer at Technoderma Medicines commented, "We are excited to see that TDM-180935 has met our expectations of a favorable safety profile in the current Phase 1 testing. As a potent JAK1/Tyk2 small molecule inhibitor, it may offer significant advantages regarding efficacy and safety compared to existing topical treatments for Atopic Dermatitis."

"This is a major milestone for the Company as we can now transition our second clinical program into Phase 2. We continue to build a robust and sustainable pipeline of drug candidates in multiple phases of clinical development," said Zengquan Wang, PhD, Chief Executive Officer at Technoderma Medicines. "We are well on our way to produce a portfolio of dermatology drug candidates."

About TDM-180935

TDM 180935 is a small molecule drug candidate being developed as a topical drug for treatment of Atopic Dermatitis. It functions as a potent JAK1/Tyk2 small molecule inhibitor. Preclinical assessment of TDM-180935 has demonstrated efficacy in multiple models and that it is well-suited for topical administration. Functional cell assays demonstrate that TDM-180935 can effectively suppress both keratinocyte- and T cell-derived pathogenic pathways characteristic for Atopic Dermatitis. Testing in rats and minipigs demonstrated favorable toxicology and toxicokinetic profiles. 

About Atopic Dermatitis (AD)

Atopic Dermatitis (AD), also called eczema, is a chronic relapsing pruritic inflammatory skin disorder that typically affects the face, neck, hands and feet, and flexor aspects of extremities. Depending on disease stages (acute, subacute, chronic), typical AD lesions include redness, swelling, cracked or excoriated skin, scaly erythema or plaques with or without exudates, and lichenification, accompanied by severe pruritus and skin dryness. Repeated scratching triggers a self-perpetuating itch-scratch cycle, which can have a significant impact on quality of life. The worldwide prevalence of AD is estimated to be 15-20% in children and 1-3% in adults, and the incidence has increased by 2- to 3-fold during the past decades in industrialized countries. The pathogenesis of AD involves four major aspects: disruption of skin barrier function, exposure to allergens, microbial infection, and dysregulated immune function. There are two major risk factors of developing AD: one is the genetic defect in the gene FLG encoding profilaggrin, the precursor of filaggrin protein present in the granular layer of the epidermis where it brings structural proteins together to create a strong barrier matrix; the other major risk factor is a family history of atopic diseases such as food allergy, allergic rhinitis, and asthma.

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 Tianfu BioPark, Sichuan, 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 completing Phase 2a clinical testing. Technoderma's novel JAK1/TYK2 inhibitor TDM-180935 for Atopic Dermatitis has now completed Phase 1 clinical testing. The pipeline targets dermatologic indications.

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