Release time: 2023-02-08 Article source: 特科罗
On February 8, 2023 (PT, UTC-8), TechnoDerma Medicines Inc. (hereinafter referred to as " TechnoDerma "), which focuses on the R&D of new topical drugs, officially announced that it had initiated the phase I clinical trial of its TDM-180935 topical ointment for atopic dermatitis/eczema. It’s now being used on healthy volunteers.
It is reported that the phase I study includes two groups: single dose and multiple dose ascending. The study adopts "randomized, double-blinded, vehicle controlled, parallel group, dose escalation study to evaluate the safety, tolerability and pharmacokinetics of TDM-180935 following topical administration in healthy male subjects". The objective of the clinical trial is toevaluate the safety and pharmacokinetics of TDM-180935 ointment for topical use. At present, FDA has approved the clinical application (IND) of the drug. The trial is now conducted in an institution in the United States.
TechnoDerma CMO Arthur P. Bertolino:
"We expect that the ongoing clinical trial can guide us to choose the labelstrengths appropriate for the phase II clinical trial, and achieve proof-of-concept (PoC) in it. We expect to use this ointment for patients with atopic dermatitis/eczema in the future phase II clinical trial. We also hope to see the selective advantage of TDM-180935 as a high-efficiency JAK1/TYK2 small-molecule inhibitor.
TechnoDerma CEO Zengquan Wang:
"TDM-180935 is the second blockbuster and breakthrough clinical product in the TechnoDerma’s pipeline of the treatment of skin indications. Previously, the company has completed the phase I clinical trial of TDM-105795 tincture in androgen alopecia (AGA), and is expected to initiate the phase II clinical trial in the middle of March 2023. We are trying to push the third product in the pipeline to the clinical before the end of the year."