Release time: 2025-01-06 Article source: 特科羅
January 6,2025,Technoderma Medicines, Inc. (“the Company”), a clinical stage biopharmaceutical company, is pleased to report the Company has completed its Phase 2a clinical trial (NCT06363461) of topical TDM-180935 ointment in patients with Atopic Dermatitis (AD). This clinical trial in the AD program included 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 was a randomized, vehicle-controlled, parallel group comparison study with an open-label PK substudy. Results show that the treatment was well-tolerated and demonstrated strong efficacy. Only minimal systemic exposure was evident and, thus, will enable future application to large body surface areas often seen in AD. These positive results provide support for continued advancement of the Atopic Dermatitis program.
The study design examined 24 patients with mild to moderate AD comparing 1% and 2% TDM-180935 to matched placebos in the core study along with 6 additional patients treated open-label with 2% TDM-180935 in the PK substudy. The primary efficacy endpoint scored for change from baseline in m-EASI at week 8 and was met in the high strength 2% TDM-180935 randomized cohort and further supported by positive responses in the corresponding open-label cohort. Substantial m-EASI-75 and m-EASI-90 reponses were clearly achieved in all active treatment groups. In addition, the registration efficacy endpoint of proportion of patients with vIGA-AD score of 0 to 1 with ≥ 2 point improvement from baseline demonstrated a positive dose response of 12.5%, 37.5%, and 62.5% for pooled placebo, 1% TDM-180935, and 2% TDM-180935, respectively. One patient on placebo left the study due to flare of disease at application sites but TEAEs were otherwise unremarkable. There were no SAEs or other safety signals. Only 2 of 6 patients in the open label PK group (mean BSA 5.2% for cohort) had measurable plasma drug levels and those were under 1 ng/mL.
Arthur P. Bertolino, MD, PhD, MBA, Chief Medical Officer at Technoderma Medicines commented, “The current study results demonstrate Proof-of-Concept for TDM-180935 regarding efficacy and guides choice of the 2% ointment formulation strength as appropriate for continued development in our AD program. We remain encouraged by the selective advantages that may be provided by TDM-180935 as a potent JAK1/Tyk2 small molecule inhibitor.”
“We are pleased with this clinical study confirming excellent toleration and minimal systemic absorption of TDM-180935 ointment and now demonstrating strong preliminary efficacy in Atopic Dermatitis. The continued advancement of this second program in our clinical development portfolio validates our capabilities in developing multiple pipeline products for treatment of dermatologic diseases,” said Zengquan Wang, Chief Executive Officer at Technoderma Medicines. “We are further reassured by also seeing a positive response in the key registration efficacy endpoint so early in 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. 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 previously 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, Lupus Erythematosus, and scar prevention. 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 has now demonstrated a favorable safety profile and positive Proof-of-Concept in Ph2a testing. The Company expects to bring a novel oral drug program into Phase 1 clinical testing for other inflammatory skin diseases soon in 2025. The pipeline targets dermatologic indications.
INVESTOR AND MEDIA CONTACT
Technoderma Medicines, Inc.
Zengquan Wang, PhD, CEO
