Oral TYK2 inhibitor demonstrates efficacy in Phase 2b study in moderate-to-severe plaque psoriasis

A Phase 2b clinical trial of TAK-279 (NDI-034858), an oral allosteric tyrosine kinase 2 (TYK2) inhibitor, in patients with moderate-to-severe plaque psoriasis met its primary and secondary endpoints, according to data presented at the American Academy of Dermatology (AAD) Annual Meeting.

In the study, 259 patients were randomized to receive 1 of 4 doses of TAK-279 once-daily, or placebo for 12 weeks. A statistically significantly greater proportion of patients taking TAK-279 achieved Psoriasis Area and Severity Index (PASI) 75, 90, and 100 in the 5mg, 15mg, and 30mg dosing arms compared to placebo.

Adverse events (AEs) occurred in 53-62% in the treatment arms and 44% in the placebo arm.

“The Phase 2b TAK-279 results demonstrate a strong overall clinical benefit and, importantly, a significant number of patients reached PASI 90 or 100, achieving near-total or total skin clearance,” said April Armstrong, MD, MPH, clinical investigator in the Phase 2b study and Associate Dean and Professor of Dermatology at the University of Southern California in a press release. “These results further support the potential of highly selective TYK2 inhibition to provide an effective and convenient oral treatment option for people living with moderate-to-severe plaque psoriasis who are not achieving optimal skin clearance with current therapies. I look forward to the results of future clinical trials.”

Read the full press release here.