Chinese biopharmaceutical company Technoderma Medicines has concluded a Phase I clinical trial of TDM-180935 topical ointment for the treatment of atopic dermatitis.
The randomised, double-blind trial analysed TDM-180935’s tolerability, safety and pharmacokinetics in healthy male participants, who were divided into single-dose and multidose escalation cohorts.
It also included a clinical study site in the US under an open investigational new drug application (IND) filed with the Food and Drug Administration (FDA).
Tested doses ranging from 0.25% to 2% were found to be well-tolerated, with no material safety issues detected.
In addition, bioanalytical data showed that once-a-day application of varying doses of the ointment for four weeks caused negligible or no systemic exposure.
Technoderma Medicines chief medical officer Arthur Bertolino said: “We are excited to see that TDM-180935 has met our expectations of a favourable safety profile in the current Phase I testing.
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“As a potent JAK1/Tyk2 small molecule inhibitor, it may offer significant advantages regarding efficacy and safety compared to existing topical treatments for atopic dermatitis.”
TDM 180935 is an inhibitor of JAK1/Tyk2 that is currently in development as a topical drug to treat atopic dermatitis.
Pre-clinical data have shown that the drug offers efficacy in various models and is suitable for topical application.
TDM-180935 is also proven to hinder keratinocyte-derived and T cell-derived pathogenic pathways specific to atopic dermatitis in functional cell assays.
Favourable toxicology and toxicokinetic profiles of the drug have been reported in assessment in rats and minipigs.
Technoderma Medicines CEO Zengquan Wang said: “This is a major milestone for the company as we can now transition our second clinical programme into Phase II.
“We continue to build a robust and sustainable pipeline of drug candidates in multiple phases of clinical development.
“We are well on our way to produce a portfolio of dermatology drug candidates.”