Topical JAK, TYK inhibitor shows efficacy in phase 2a trial for atopic dermatitis

Key takeaways:

• The study, comparing the 1% and 2% formulations of the drug, found the 2% topical to be effective.
• 62.5% of patients treated with TDM-180935 2% reached the primary endpoint by week 8.

Technoderma Medicines has completed its phase 2a trial of TDM-180935 for the treatment of atopic dermatitis, demonstrating the efficacy of the ointment’s 2% formulation, the company announced in a press release.

TDM-180935 is a topical Janus kinase (JAK)-1/tyrosine kinase (TYK)-2 inhibitor ointment that has previously completed a phase 1 study that showed excellent toleration and minimal systemic absorption for patients with AD. The results of this phase 2a study add to the evidence supporting further investigation into TDM-180935 2%.

“The current study results demonstrate proof-of-concept for TDM-180935 regarding efficacy and guides choice of the 2% ointment formulation strength as appropriate for continued development in our AD program,” Arthur P. Bertolino, MD, PhD, MBA, chief medical officer at Technoderma Medicines, said in the press release. “We remain encouraged by the selective advantages that may be provided by TDM-180935 as a potent JAK-1/TYK-2 small molecule inhibitor.”

The study included 24 patients with mild to moderate AD who were randomly assigned to receive TDM-180935 1%, TDM-180935 2% or placebo for 8 weeks. Additionally, the study included an open-label pharmacokinetics sub study where another six patients applied the 2% formulation.

According to the press release, all active treatment groups achieved “substantial” modified EASI 75 and modified EASI 90 responses.

A total of 12.5%, 37.5% and 62.5% of patients in the pooled placebo, TDM-180935 1% and TDM-180935 2% groups, respectively, achieved the primary endpoint of IGA 0 or 1 and a 2-point or more improvement from baseline at week 8.

Treatment-emergent adverse events were deemed “unremarkable,” with only one patient in the placebo arm leaving the study due to flare-ups of the disease on the application sites. Plasma drug levels were elevated in two of the six pharmacokinetics patients; however, these levels were under 1 ng/mL.

No serious adverse events were reported.