Technoderma Medicines, Inc.’s is now dosing atopic dermatitis (AD) patients in its Phase 2a clinical trial of topical TDM-180935 ointment.
TDM-180935 is a Janus Kinase 1 (JAK1)/tyrosine-protein kinase 2 (TYK2) small molecule inhibitor.
This clinical trial includes eight weeks dosing of two different active formulation strengths and placebo. It is a randomized, vehicle-controlled, parallel group comparison study with an open-label pharmacokinetic sub-study. Objectives are to evaluate the safety and efficacy of topical TDM-180935 as well as pharmacokinetics. Seven U.S. clinical sites are currently participating in this study under an open Investigational New Drug Application from the U.S. Food and Drug Administration.
“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,” says Arthur P. Bertolino, MD, PhD, MBA, Chief Medical Officer at Technoderma Medicines , in a news release. “We are encouraged by the selective advantages that maybe 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,” adds Zengquan Wang, Chief Executive Officer at Technoderma Medicines. “We are working to bring a steady stream of pipeline products into clinical testing.”
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 AD. 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.
