- Once-daily oral zasocitinib demonstrated statistical superiority over deucravacitinib for all primary and key secondary endpoints in plaque psoriasis study
- More than 35% of zasocitinib-treated patients achieved complete skin clearance (PASI 100) at week 16 – more than 2.5 times the response rate for deucravacitinib
- Safety profile was consistent with previous studies with no new safety signals identified
TORONTO, June 23, 2026 /CNW/ - Takeda Canada Inc. ("Takeda") is pleased to announce positive topline results for the Phase 3, randomized, multicenter, double-blind study comparing zasocitinib (TAK-279), an investigational, next-generation, highly selective and potent oral tyrosine kinase 2 (TYK2) inhibitor, to deucravacitinib in adults with moderate-to-severe plaque psoriasis (PsO).
In the LATITUDE Atlas (TAK-279-PsO-3004) head-to-head study, zasocitinib demonstrated statistical superiority over deucravacitinib for the primary endpoint, Psoriasis Area and Severity Index (PASI) 100 response rate at week 16. The study also demonstrated statistical superiority over deucravacitinib for all key secondary endpoints, including PASI 90 response and Static Physician's Global Assessment (sPGA) 0 at week 16. Zasocitinib was generally well tolerated with a consistent safety and tolerability profile and no new safety signals identified. The study was conducted across eight countries and enrolled 606 participants, including 73 patients across 18 sites in Canada.
Perspectives on head-to-head zasocitinib study
"For patients living with moderate-to-severe plaque psoriasis, achieving complete skin clearance remains an important treatment goal," said Linda Stein Gold, M.D., Director of Dermatology Clinical Research at Henry Ford Health and principal investigator for the LATITUDE Atlas study. "These head-to-head Phase 3 results are encouraging because they show the potential for an oral therapy to deliver high levels of skin clearance. With Canadian patients participating in the LATITUDE Atlas study, these findings are an important contribution to the evolving treatment landscape."
"These Phase 3 results reinforce the potential of zasocitinib as a meaningful oral treatment option for people living with moderate-to-severe plaque psoriasis," said Thiago Magalhães, Head of Specialty BU, Takeda Canada. "We are encouraged by the high levels of skin clearance observed in this study and remain committed to advancing innovative therapies that may help address unmet needs for patients in Canada."
Next steps for head-to-head study and development program for zasocitinib in psoriasis
Takeda intends to present detailed data from the head-to-head study at upcoming medical congresses, building on landmark Phase 3 LATITUDE PsO results (3001 and 3002 studies) recently presented at the American Academy of Dermatology Annual Meeting. The company is on track to submit a New Drug Application for plaque psoriasis with the United States Food and Drug Administration and other regulatory authorities starting this fiscal year.
About Plaque Psoriasis
Psoriasis is a chronic immune-mediated inflammatory disease in which the body's immune system causes inflammation which results in skin cells that multiply too quickly.1 Plaque psoriasis, the most common form of psoriasis, is characterized by raised, red, gray or purple patches of skin that are itchy, painful and covered by scales.2,3,4 Psoriatic plaques can cover any part of the skin surface but are mostly found on the scalp, face, arms and elbows, legs, knees, torso, genitals, nails and in skin folds.1,5 Many people living with psoriasis experience intense itching and burning from their psoriasis plaques that disrupt their daily lives.3,4 Patients also report that their symptoms negatively impact their mental health and quality of life and can lead to social isolation.6 Globally, an estimated 64 million people are living with psoriasis and about 80-90% of those have plaque psoriasis.7,8
About Zasocitinib (TAK-279)
Zasocitinib is an investigational, next-generation, highly selective oral TYK2 inhibitor that maintains 24-hour inhibition of IL-23 plus other core disease-driving immune pathways.9,10 It has the potential to be a leading oral treatment option for people living with psoriasis that may deliver rapid and durable skin clearance in a convenient once-daily pill. Zasocitinib has more than 1-million-fold greater selectivity for TYK2 compared to other JAK enzymes, which could maximize TYK2 inhibition without impacting JAK1, 2 and 3 signaling, based on in vitro data.9,11 Takeda is currently evaluating the safety and efficacy of zasocitinib in a head-to-head study against deucravacitinib in plaque psoriasis and in Phase 3 studies in psoriatic arthritis.12,13,14 In addition, Phase 2 studies are ongoing in Crohn's disease, ulcerative colitis, vitiligo and hidradenitis suppurativa (HS).15,16,17,18 Zasocitinib is an investigational compound that has not been approved for use by any regulatory authority.
About the LATITUDE Atlas Study
The LATITUDE Atlas (NCT06973291 / TAK-279-PsO-3004) study is a Phase 3, randomized, multicenter, double-blind trial evaluating the efficacy, safety and tolerability of zasocitinib compared to deucravacitinib in adult participants with moderate-to-severe plaque psoriasis.12 The study enrolled 606 participants, who received zasocitinib 30 mg once daily or deucravacitinib 6 mg once daily up to week 16.12 Participants were in the study for up to 25 weeks, which included a screening period of up to 35 days, a 16-week treatment period, and a 4-week safety follow-up period. The primary endpoint was the percentage of participants achieving PASI 100 at week 16.12
About Tyrosine Kinase 2 (TYK2) Inhibitors
TYK2 is an intracellular enzyme and member of the Janus kinase (JAK) protein family.11,19,20 However, TYK2 is distinct from JAK1, 2 and 3 as it primarily regulates immune responses, whereas JAK1, 2 and 3 regulate broader biological processes. 11,21,22 TYK2 mediates IL-23 plus other immune and inflammatory signaling pathways that are fundamental to psoriasis, psoriatic arthritis and other immune-mediated inflammatory diseases.21 Highly selective allosteric inhibition of TYK2, with minimal inhibition of JAK1, 2 and 3, may be a promising therapeutic approach to target immune-mediated inflammation while potentially avoiding risks associated with inhibition of other members of the JAK family.22
About Takeda Canada Inc.
Takeda Canada Inc. is the Canadian organization of Takeda Pharmaceutical Company Limited (TSE: 4502/NYSE: TAK), a global, values-based, R&D-driven biopharmaceutical leader headquartered in Japan, committed to discovering and delivering life-transforming treatments, guided by our commitment to patients, our people and the planet. Takeda focuses its R&D efforts on four therapeutic areas: Oncology, Rare Genetics and Hematology, Neuroscience, and Gastroenterology (GI). We also make targeted R&D investments in Plasma-Derived Therapies and Vaccines. We are focusing on developing highly innovative medicines that contribute to making a difference in people's lives by advancing the frontier of new treatment options and leveraging our enhanced collaborative R&D engine and capabilities to create a robust, modality-diverse pipeline. Our employees are committed to improving quality of life for patients and to working with our partners in health care in approximately 80 countries and regions. For more information, visit: https://www.takeda.com/en-ca/.
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Medical Information
This press release contains information about products that may not be available in all countries, or may be available under different trademarks, for different indications, in different dosages, or in different strengths. Nothing contained herein should be considered a solicitation, promotion or advertisement for any prescription drugs including the ones under development.
This release also includes evolving scientific information that has not been reviewed by Health Canada as the safety and effectiveness of zasocitinib (TAK-279) are still under investigation. In the absence of Health Canada marketing authorization, Takeda does not recommend use of zasocitinib (TAK-279) outside of a Health Canada authorized clinical study.
References
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1 Dhabale A, Nagpure S. Types of psoriasis and their effects on the immune system. Cureus. 2022 Sep 24;14(9):e29536. doi: 10.7759/cureus.29536. Accessed June 2026.
2 Gkini MA, Nakamura M, Alexis AF, et al. Psoriasis in People With Skin of Color: An Evidence-Based Update. Int J Dermatol. 2025;64(4):667-677. doi:10.1111/ijd.17651 Accessed June 2026.
3 Taliercio VL, Snyder AM, Webber LB, et al. The Disruptiveness of Itchiness from Psoriasis: A Qualitative Study of the Impact of a Single Symptom on Quality of Life. J Clin Aesthet Dermatol. 2021;14(6):42-48. Accessed June 2026.
4 Snyder AM, Taliercio VL, Webber LB, et al. The Role of Pain in the Lives of Patients with Psoriasis: A Qualitative Study on an Inadequately Addressed Symptom. J Psoriasis Psoriatic Arthritis. 2022;7(1):29-34. doi:10.1177/24755303211066928 Accessed June 2026.
5 Dopytalska K, Sobolewski P, Błaszczak A, Szymańska E, Walecka I. Psoriasis in Special Localizations. Reumatologia. 2018;56(6):392-398. doi:10.5114/reum.2018.80718. Accessed June 2026.
6 Blackstone B, Patel R, Bewley A. Assessing and Improving Psychological Well-Being in Psoriasis: Considerations for the Clinician. Psoriasis (Auckl). 2022;12:25-33.doi:10.2147/PTT.S328447. Accessed June 2026.
7 AIQassimi S, AIBrashdi S, Galadari H, Hashim MJ. Global Burden of Psoriasis - Comparison of Regional and Global Epidemiology, 1990 to 2017. Int J Dermatol. 2020;59(5):566-571. doi: 10.llll/ijd.14864. Accessed June 2026.
8 Mehta S, Sathe NC. Plaque Psoriasis. In: StatPearls. Treasure Island (FL): StatPearls Publishing; September 14, 2025. https://www.ncbi.nlm.nih.gov/books/NBK430879/.
9 Mehrotra S, Sano Y, Halkowycz P, et al. Pharmacological Characterization of Zasocitinib (TAK-279): An Oral, Highly Selective and Potent Allosteric TYK2 Inhibitor. May 26, 2025. J Invest Dermatol. 2025 May 27:S0022-202X(25)00531-7. doi:10.1016/j.jid.2025.05.014. Accessed June 2026.
10 Shang L, et al. TYK2 in immune responses and treatment of psoriasis. J Inflamm Res. 2022;15:5373-5385. 2022 Sep 16. doi:10.2147/JIR.S380686 Accessed June 2026.
11 Leit S, Greenwood J, Carriero S, et al. Discovery of a Potent and Selective Tyrosine Kinase 2 Inhibitor: TAK-279. J Medicinal Chemistry.2023;66(15):10473-10496.doi.org/10.1021/acs.jmedchem.3c00600. Accessed June 2026.
12 A Study Comparing Zasocitinib (TAK-279) With Deucravacitinib in Adults With Plaque Psoriasis. ClinicalTrials.gov Identified: NCT06973291. Updated May 1, 2026. Accessed June 2026. https://clinicaltrials.gov/study/NCT06973291
13 Study of Zasocitinib in Adults With Psoriatic Arthritis Who Have Not Taken Biologic Medicines. ClinicalTrials.gov Identifier: NCT06671483. Updated March 9, 2026. Accessed June 2026. https://clinicaltrials.gov/study/NCT06671483.
14 A Study of Zasocitinib in Adults With Psoriatic Arthritis Who Have or Have Not Been Treated With Biologic Medicines. ClinicalTrials.gov Identifier: NCT06671496. Updated March 9, 2026. Accessed June 2026. https://clinicaltrials.gov/study/NCT06671496.
15 A Study on the Safety of TAK-279 and Whether it Can Reduce Inflammation in the Bowel of Participants With Moderately to Severely Active Crohn's Disease. ClinicalTrials.gov Identifier: NCT06233461. Updated February 11, 2026. Accessed June 2026. https://clinicaltrials.gov/study/NCT06233461.
16 A Study on the Safety of TAK-279 and Whether it Can Reduce Inflammation in the Bowel of Participants With Moderately to Severely Active Ulcerative Colitis. ClinicalTrials.gov Identifier: NCT06254950. Updated March 13, 2026. Accessed June 2026. https://www.clinicaltrials.gov/study/NCT06254950.
17 A Study of Zasocitinib in Adults With Nonsegmental Vitiligo. ClinicalTrials.gov Identifier: NCT07108283. Updated March 13, 2026. Accessed June 2026. https://clinicaltrials.gov/study/NCT07108283.
18 A Takeda Presentation. Quarterly Results - Quarter 1 FY2025. Available at: https://assets-dam.takeda.com/image/upload/v1753839858/Global/Investor/Financial-Results/FY2025/Q1/qr2025_q1_p01_en.pdf. Accessed June 2026.
19 Muromoto R, Oritani K, Matsuda T. Current Understanding of the Role of Tyrosine Kinase 2 Signaling in Immune Responses. World J Biol Chem. 2022;13(1):1–14. doi:10.4331/wjbc.v13.i1.1. Accessed June 2026.
20 Danese S, Peyrin-Biroulet L. Selective Tyrosine Kinase 2 Inhibition for Treatment of Inflammatory Bowel Disease: New Hope on the Rise. Inflamm Bowel Dis. 2021;27(12):2023-2030. doi: 10.1093/ibd/izab135. Accessed June 2026.
21 Rusiñol L, Puig L. Tyk2 Targeting in Immune-Mediated Inflammatory Diseases. Int J Mol Sci. 2023;24(4):3391. Published 2023 Feb 8. doi:10.3390/ijms24043391. Accessed June 2026.
22 Krueger JG, McInnes IB, Blauvelt A. Tyrosine Kinase 2 and Janus Kinase‒Signal Transducer and Activator of Transcription Signaling and Inhibition in Plaque Psoriasis. J Am Acad Dermatol. 2022;86(1):148-157. doi:10.1016/j.jaad.2021.06.869. Accessed June 2026. |
SOURCE Takeda Canada, Inc.
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