Significant Improvement in Arthritis Symptoms! Takeda's TYK2 Inhibitor to Enter Phase 3 Trial

▎WuXi

Edited by Kant Content Team

Takeda announced today that its investigational oral TYK2 inhibitor TAK-279 has achieved positive results in a Phase 2b trial for the treatment of patients with active psoriatic arthritis. Analysis shows,The trial met its primary endpointCompared with placebo, a higher proportion of patients receiving once-daily TAK-279 treatment experienced at least a 20% improvement in signs and symptoms of the disease by week 12. Takeda plans to present detailed data at an upcoming medical conference. Based on these positive results,Takeda Plans to Launch Phase 3 Trial of the Therapy for Psoriatic Arthritis.

Psoriatic Arthritis: A Chronic Immune-Mediated Inflammatory DiseasePsoriatic arthritis is a chronic immune-mediated inflammatory disease characterized by joint pain, stiffness, and swelling caused by inflammation, affecting approximately 10 million people worldwide. If not properly managed, the chronic inflammation observed in psoriatic arthritis can lead to irreversible joint damage, disease progression, and severe physical disability. This condition is also associated with mental health disorders such as anxiety and depression.

TAK-279 is a highly selective oral allosteric TYK2 inhibitor., is being evaluated for the treatment of various autoimmune diseases.

The trial announced this time is a randomized, double-blind, multi-center, placebo-controlled, multiple-dose Phase 2b trial designed to evaluate the efficacy, safety, and tolerability of TAK-279 in patients with active psoriatic arthritis. A total of 290 patients were randomly assigned (in a 1:1:1:1 ratio) to receive one of three doses of TAK-279 or a placebo once daily for 12 weeks, followed by a 4-week safety follow-up period. The primary endpoint of the trial was the proportion of patients achieving at least an ACR20 response at week 12. ACR20 is an improvement criterion based on the American College of Rheumatology standards, defined as a 20% improvement in both tender and swollen joint counts, along with a 20% improvement in three of the following five criteria: patient’s global assessment of psoriatic arthritis, physician’s global assessment of psoriatic arthritis, patient pain scale, health assessment questionnaire, and acute-phase reactants.

Analysis shows,Compared with placebo, a higher proportion of patients receiving once-daily TAK-279 treatment experienced at least a 20% improvement in signs and symptoms of the disease by Week 12.The safety and tolerability profile of TAK-279 in the trial was consistent with previous clinical trials. Based on these results, Takeda plans to initiate a Phase 3 study of TAK-279 for the treatment of psoriatic arthritis. Additionally,Takeda also expects to initiate a Phase 3 trial of TAK-279 for the treatment of plaque psoriasis in the fiscal year 2023 and plans to evaluate TAK-279 in systemic lupus erythematosus, Crohn's disease, ulcerative colitis, and other immune-mediated inflammatory diseases.