Technoderma Medicines Advances TDM-180935 Atopic Dermatitis Clinical Program with Phase 2 Trial

Release time: 2024-04-30 Article source: 特科罗

CHENGDU, China – April , 2024 (XYZ Newswire) Technoderma Medicines, Inc. (“the Company”), a clinical stage biopharmaceutical company, is pleased to report the Company has begun dosing patients in its Phase 2a clinical trial (NCT 06363461) of topical TDM-180935 ointment. This clinical trial in the Atopic Dermatitis (AD) program includes 8 weeks dosing of two different active formulation strengths and placebo in a study entitled, “A Randomized, Vehicle-Controlled, Parallel Group Study of Topical TDM-180935 to Evaluate the Preliminary Efficacy, Safety, Tolerability, and Pharmacokinetics in Atopic Dermatitis Patients”. It is a randomized, vehicle-controlled, parallel group comparison study with an open-label PK sub-study.  Objectives are to evaluate the safety and efficacy of topical TDM-180935 as well as pharmacokinetics.【duplicate with no new info, suggest deleting】 Seven U.S. clinical sites are currently participating in this study under an open IND with FDA.

Arthur P. Bertolino, MD, PhD, MBA, Chief Medical Officer at Technoderma Medicines commented, “We  expect the current study to support Proof-of-Concept for TDM-180935 regarding efficacy and to guide choice of formulation strength(s) appropriate for continued development in our AD program. We are encouraged by the selective advantages that may be provided by TDM-180935 as a potent JAK1/Tyk2 small molecule inhibitor.”

“We are pleased with the excellent toleration and minimal systemic absorption already exhibited by TDM-180935 ointment in Phase 1 development and now look forward to assessing its preliminary efficacy in Atopic Dermatitis. The advancement of this second program in our portfolio into Phase 2 development validates our capabilities in developing multiple pipeline products for treatment of dermatologic diseases,” said Zengquan Wang, Chief Executive Officer at Technoderma Medicines. “We are working to bring a steady stream of pipeline products into clinical testing.”

About TDM-180935

TDM180935 is a small molecule drug candidate being developed as a topical drug for treatment of Atopic Dermatitis. As a potent JAK1/Tyk2 small molecule inhibitor, it may offer significant advantages regarding efficacy and safety compared to existing topical treatments. Preclinical assessment of TDM180935 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. Phase 1 clinical testing of topical TDM-180935 ointment has demonstrated excellent toleration and minimal systemic absorption. 

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 located in 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 successfully completed Phase 2a clinical testing and is further advancing in development. Technoderma's novel JAK1/TYK2 inhibitor TDM-180935 for Atopic Dermatitis completed Phase 1 clinical testing with a favorable safety profile and is now entering Ph2a testing. The pipeline targets dermatologic indications.