Chinese biopharmaceutical company Technoderma Medicines has begun dosing patients in its Phase IIa clinical trial of topical TDM-180935 ointment, a potential treatment for atopic dermatitis (AD).
The eight-week trial will assess the two different strengths of the topical medication compared with a placebo.
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It is being conducted as a vehicle-controlled, randomised, parallel-group comparison trial with an open-label pharmacokinetics sub-study.
The study will be carried out at seven US-based clinical sites under an open investigational new drug (IND) application filed with the Food and Drug Administration (FDA).
Technoderma Medicines chief medical officer Arthur Bertolino said: “We expect the current study to support proof-of-concept for TDM-180935 regarding efficacy and to guide the choice of formulation strength(s) appropriate for continued development in our AD programme.
“We are encouraged by the selective advantages that may be provided by TDM-180935 as a potent JAK1/Tyk2 small molecule inhibitor.”
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By GlobalDataTDM-180935 is a small-molecule drug candidate designed as a topical AD treatment, functioning as a potent inhibitor of JAK1/Tyk2.
Preclinical studies have shown the ointment to be effective in multiple models and well-suited for topical application, with the potential to offer significant improvements in efficacy and safety compared with existing treatments.
Phase I clinical testing of the topical ointment indicated toleration and minimal systemic absorption, suggesting a promising safety profile for further clinical development.
Technoderma Medicines CEO Zengquan Wang said: “The advancement of this second programme in our portfolio into Phase II development validates our capabilities in developing multiple pipeline products for the treatment of dermatologic diseases.
“We are working to bring a steady stream of pipeline products into clinical testing.”
Based in Sichuan, Technoderma Medicines develops novel therapies for androgenetic alopecia, AD, psoriasis and lupus erythematosus.
Earlier this year, the company reported data from a Phase IIa clinical trial of its small-molecule drug candidate TDM-105795 for treating androgenetic alopecia.
