SAN DIEGO, Feb. 9, 2023 /PRNewswire/ -- Technoderma Medicines, Inc. ("the Company"), invested and incubated by Viva BioInnovator (VBI), is a clinical stage biopharmaceutical company. They were pleased to report the Company has begun dosing healthy volunteer subjects in its Phase 1 clinical trial of topical TDM-180935 ointment. This first clinical trial in the Atopic Dermatitis (AD) program includes 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 are to evaluate the safety and pharmacokinetics of topical TDM-180935. One U.S. clinical site is 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 guide choice of formulation strength(s) appropriate for a subsequent proof-of-concept (PoC) Phase 2 Atopic Dermatitis study. We look forward to including patients with AD in the next clinical study and are encouraged by the selective advantages that may be provided by TDM-180935 as a potent JAK1/Tyk2 small molecule inhibitor."
"We view the TDM-180935 AD program as the second 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 third pipeline product into clinical testing later this year."
TDM–180935 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 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 atopic 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 Jiaxing Xiuzhou Biomedicine Guoqian Park, 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 entering Phase 2a clinical testing. Technoderma's novel JAK1/TYK2 inhibitor TDM-180935 for Atopic Dermatitis has now begun Phase 1 clinical testing. The pipeline targets dermatologic indications.