Takeda Launches Phase 3 Trials in China for Zasocitinib (TAK-279), a TYK2 Inhibitor Acquired for $6 Billion, in Moderate-to-Severe Plaque Psoriasis

Screenshot source:China Drug Clinical Trial Registration and Information Disclosure Platform Official Website

Takeda has launched two Phase 3 clinical trials in China, both of which aim to evaluateTAK-279 30mg once dailyOralDrug AdministrationModerate to Severe Plaque PsoriasisSafety and efficacy. The medication duration in one of the studies was 52 weeks,Another study included a randomized withdrawal and re-treatment period, with a medication duration of 60 weeks. According toClinicalTrials.govThe information queried indicates that these two international Phase 3 clinical trials were initiated in November 2023.Global target enrollment: 1600 people。

The launch of two international Phase 3 clinical trials is an important advancement in the global development of this TYK2 inhibitor, bringing this investigational new drug one step closer to benefiting patients.

Takeda announced positive results from the Phase 2b clinical study of TAK-279 tablets for the treatment of moderate to severe plaque psoriasis in March 2023. At 12 weeks,30mg A higher proportion of patients in the TAK-279 treatment group achieved a 75% improvement in the Psoriasis Area and Severity Index from baseline (PASI 75).67% vs The placebo group is6%), meeting the primary endpoint of the study. Additionally, patients in the 30mg groupAchieving PASI 90 andPASI The proportion of 100 is also higher, respectively46% and33%, The value for placebo is0%. PASI 90 orPASI 100 represents patients achieving nearly complete or complete skin clearance.

Psoriasis is a chronic autoimmune disease.Plaque psoriasis is one of the common forms, characterized by raised red patches of skin covered with silvery-white scales, and may be accompanied by itching and pain.This disease not onlyAffecting patients' physical health, it has also become a source of stress for emotional well-being, interpersonal relationships, and daily life.

Fortunately, in recent years, there have been certain advances in therapies for psoriasis, with multiple emerging treatments making progress, including TYK2 inhibitors.TYK2 is involved in the signal transduction of various cytokines and mediates downstream STAT phosphorylation, a pathway that has been demonstrated to be a major pathogenic mechanism in psoriasis and other autoimmune diseases.Research shows，TYK2 Regulates Cytokines Such as IL-23, IL-12, and Type I IFN Without Affecting Other Cytokines。Therefore,Inhibition of TYK2 is expected to reduce the side effects associated with the suppression of other JAK family members.A safer and more effective treatment option for psoriasis and other autoimmune diseases.

We look forward to the smooth progress of Takeda's international Phase 3 clinical trial for this TYK2 inhibitor, bringing more and better treatment options to patients with psoriasis.

In addition to Takeda's TAK-279 tablets, there are quite a few TYK2 inhibitors globally that are under development or have already made breakthroughs in the treatment of psoriasis. For example,Deucravacitinib TabletsPreviously approved in the United States, China, and other countries for the treatment of plaque psoriasis, dual-target TYK2/JAK1 inhibitorTLL-018Has achieved positive results in Phase 1 clinical trials for the treatment of psoriasis,TYK2-JH1 InhibitorICP-332And TYK2-JH2 InhibitorsICP488Positive data has also been achieved in clinical research for psoriasis. In addition, the TYK2/JAK1 dual inhibitor brepocitinib and the TYK2/JAK1 inhibitor AC-201 have entered phase 2 clinical trials for the treatment of plaque psoriasis... Due to space limitations, we will not list them all here. We hope these products proceed smoothly in subsequent clinical applications and development, benefiting more patients with psoriasis.

[2] Takeda Announces Positive Results in Phase 2b Study of Investigational TAK-279, an Oral, Once-Daily TYK2 Inhibitor, in People with Moderate-to-Severe Plaque Psoriasis. Retrieved Mar 18, 2023 from https://www.takeda.com/newsroom/newsreleases/2023/takeda-announces-positive-results-in-phase-2b-study-of-investigational-tak-279/

[3]ClinicalTrialsOfficial Website. From https://clinicaltrials.gov/study/NCT06088043?term=TAK-279&page=1&rank=10