Technoderma Medicines has commenced dosing with its topical TDM-180935 ointment in healthy volunteer subjects in its Phase I study for Atopic Dermatitis (AD).
This is said to be the first trial in the AD programme and includes single dose, as well as multidose, escalation cohorts.
The double-blind, randomised, vehicle-controlled, parallel group, dose escalation trial will assess the tolerability, safety, and pharmacokinetics of the ointment after topical administration in healthy male subjects.
Assessing the safety and pharmacokinetics of topical TDM-180935 are the objectives of the trial.
One study site in the US is participating in this trial at present under an open IND with the FDA.
Technoderma Medicines chief medical officer Arthur Bertolino said: “We expect the current study to guide choice of formulation strength(s) appropriate for a subsequent proof-of-concept (PoC) Phase II AD study.
“We look forward to including patients with AD in the next clinical study and are encouraged by the selective advantages that may be provided by TDM-180935 as a potent JAK1/Tyk2 small molecule inhibitor.”
TDM–180935 is being developed as a topical drug to treat AD, which is also known as atopic eczema.
As a potent JAK1/Tyk2 small molecule inhibitor, the drug candidate is expected to offer advantages with regards to safety and efficacy against topical treatments that are currently available.
Technoderma Medicines CEO Zengquan Wang said: “We view the TDM-180935 AD programme as the second clinical anchor among our pipeline products for treatment of various dermatologic diseases.
“We are working to bring a third pipeline product into clinical testing later this year.”