DermWire’s AD Pipeline Watch: TDM 180935 Performs Well in Phase 1 Study

TDM 180935 is a small molecule drug candidate that functions as a potent JAK1/Tyk2 small molecule inhibitor.

Technoderma Medicines, Inc. has completed a Phase 1 clinical trial of TDM-180935 topical ointment for Atopic Dermatitis (AD). 

TDM 180935 is a small molecule drug candidate that functions as a potent JAK1/Tyk2 small molecule inhibitor. 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 AD. 

This first clinical trial in the AD program included 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 were to evaluate safety and pharmacokinetics of topical TDM-180935; one U.S. clinical site participated in this study under an open IND with FDA. All strengths of TDM-180935 (0.25%-2.0%) were well tolerated with no material safety issues identified. Bioanalytical results show that once daily application of TDM-180935 for 4 weeks over the range of doses studied produces extremely low to no systemic exposure.

"We  are excited to see that TDM-180935 has met our expectations of a favorable safety profile in the current Phase 1 testing,” says Arthur P. Bertolino, MD, PhD, MBA, Chief Medical Officer at Technoderma Medicines, in a news release.  “As a potent JAK1/Tyk2 small molecule inhibitor, it may offer significant advantages regarding efficacy and safety compared to existing topical treatments for AD."