Takeda Pharmaceutical Company (4502) investor relations material

Study design and methodology

• Two pivotal phase III studies (Latitude PsO 3001 and 3002) evaluated zasocitinib, a highly selective oral TYK2 inhibitor, in adults with moderate-to-severe plaque psoriasis, using randomized, double-blind, placebo- and apremilast-controlled designs.

• Study 3001 enrolled ~690 patients (3:1:1 zasocitinib:apremilast:placebo); study 3002 enrolled >1,100 patients (2:1:1 ratio), with a randomized withdrawal phase for responders at week 40.

• Co-primary endpoints were sPGA 0/1 and PASI 75 at week 16 versus placebo; secondary endpoints included PASI 90, PASI 100, DLQI improvements, and maintenance of response through week 60.

• Eligibility required adults with plaque psoriasis for ≥6 months, PASI ≥12, sPGA ≥3, and ≥10% BSA.

• Baseline demographics were balanced; about one-third of patients were bio-experienced, with higher BMI and more severe disease in 3002.

Efficacy results

• Zasocitinib met both co-primary endpoints and all ranked secondary endpoints in both studies, significantly outperforming placebo and apremilast.

• At week 16, sPGA 0/1 was achieved by 71–74% and PASI 75 by 76–77%, compared to 11–13% and ~12% for placebo.

• Rapid skin clearance was observed as early as week 4, with early separation from comparators for PASI 75 and sPGA 0/1.

• By week 24, up to 69% achieved PASI 90, 49% achieved clear skin (sPGA 0), and 42% achieved PASI 100, with efficacy continuing to improve through week 24.

• Quality of life improved rapidly, with up to 60% reporting DLQI 0/1 by week 24.

Durability and withdrawal data

• Over 90% of patients continuing zasocitinib at week 40 maintained sPGA 0/1, PASI 75, and PASI 90 through week 60.

• Patients switched to placebo lost response slowly; over 50% maintained response 20 weeks after withdrawal, suggesting resilience to missed doses.