Technoderma Medicines Completes Positive Ph2a Proof- of Concept Trial with Topical TDM-180935 Ointment for Atopic Dermatitis

CHENGDU, China, Jan. 6, 2025 /PRNewswire/ -- 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."