Technoderma Medicines Receives FDA Approval for Its Atopic Dermatitis Drug IND

Release time: 2022-08-09 Article source: 澳门355彩票娱乐

On Aug 9th, 2022, US Pacific Time, Technoderma Medicines (TDM), a drug discovery startup specialized in dermatology indications based at Jiaxing,China, announced that FDA approved the IND application of its novel experimental drug for the topical treatment of Atopic Dermatitis (AD) by issuing a STUDY MAY PROCEED letter on Aug 1st, 2022. Phase I clinical trials will be carried out in several clinical sites in the US.

TDM-180935, TDM’s experimental drug approved in the IND application, is the first one out of several preclinical candidates from the company’s small molecule JAK inhibitor discovery program to enter clinical phase. Based on kinase, cellular and functional assays, TDM-180935 is a JAK1/TYK2 dual inhibitor.

Preclinical MoA studies revealed that TDM-180935 can potently inhibit Th2 immune response characteristic for the initiating phase of AD pathogenesis, as well as Th1 and Th17 immune responses that play a role during the chronic phase, thereby efficiently blocking all major pathogenic pathways leading to AD. The drug demonstrated dose-dependent efficacy on three mouse models for AD and a good safety profile as indicated by GLP toxicology studies.

TDM-180935 is the company’s second IND approval by FDA. Previously, TDM-105795, a small molecule thyroid hormone receptor agonist for the topical treatment of Androgenetic Alopecia (AGA) has been approved for phase I clinical trials in April 2021. Phase I trials of TDM-105795 will be completed in Q4 2022 and phase II trials are scheduled to start in Dec 2022 or Jan 2023.