Zasocitinib Delivered Superior Efficacy Versus Deucravacitinib in New Phase 3 Head-to-Head Results, Reinforcing Potential to Deliver Rapid and Durable Skin Clearance in a Convenient Once-Daily Pill

Takeda (TSE:4502/NYSE:TAK) announced new data from threePhase 3 LATITUDE psoriasis studies of zasocitinib (TAK-279), an investigational, next-generation, highly selective and potent oral tyrosine kinase 2 (TYK2) inhibitor, in adults with moderate-to-severe plaque psoriasis.¹ Presented during late-breaking and oral sessions at the European Academy of Dermatology & Venereology (EADV) Congress 2026, these results demonstrate zasocitinib’s superior efficacy compared to deucravacitinib and reinforce the potential for zasocitinib to deliver rapid, durable and consistent skin clearance in a convenient once-daily pill.^2-5

“Psoriasis is a heterogeneous disease driven by multiple immune pathways and TYK2 plays a central role in regulating several key inflammatory signals,” said Chinwe Ukomadu, M.D., Ph.D., Senior Vice President and Head, Gastrointestinal & Inflammation Therapeutic Area Unit at Takeda. “Across our Phase 3 trials, zasocitinib demonstrated superiority versus two distinct oral therapeutic classes in addition to rapid, durable and consistent skin clearance across patient types and in high-impact, hard-to-treat areas. The totality of these results underscores its potential to redefine what patients and physicians can expect from an oral psoriasis treatment.”

Late-breaking, head-to-head results reinforce potential of zasocitinib as a next-generation TYK2 inhibitor
In the Phase 3 LATITUDE Atlas (TAK-279 PsO 3004) head-to-head study, zasocitinib demonstrated statistical superiority over deucravacitinib across the primary and all key secondary efficacy endpoints with higher rates of complete skin clearance observed as early as week 8 and more than 2.5 times as many patients achieving complete skin clearance at week 16.²

• 36.5% of patients treated with zasocitinib (n=301) achieved complete skin clearance (Psoriasis Area and Severity Index (PASI) 100) at week 16 versus 13.9% in the deucravacitinib group (n=303; p<0.001).²
• 62.5% of patients treated with zasocitinib achieved PASI 90 at week 16 versus 34.0% in the deucravacitinib group (p<0.001).²
• 43.2% of patients treated with zasocitinib achieved clear skin (static Physician Global Assessment (sPGA) 0) at week 16 versus 18.5% in the deucravacitinib group (p<0.001).²
• Zasocitinib was generally well-tolerated with no new safety signals identified.² The safety and tolerability profile of zasocitinib remained consistent with prior Phase 3 psoriasis studies.^2-5 The most common adverse events across Phase 3 LATITUDE psoriasis trials were upper respiratory tract infection, nasopharyngitis and acne.^2-5

Pivotal data show durable skin clearance and rapid and continued improvements in itch and quality of life
New long-term data from the pivotal Phase 3 LATITUDE PsO 3001 and 3002 studies demonstrated durable skin clearance with zasocitinib through week 52.³ Among patients who achieved a response at week 24, up to 93% maintained their skin clearance results through week 52 in LATITUDE PsO 3001 (post-hoc analysis) and week 40 in LATITUDE PsO 3002.³

Additional data from the pivotal Phase 3 LATITUDE PsO 3001 and 3002 studies demonstrated that zasocitinib-treated patients reported improvements in itch and quality of life as early as week 2 with continued improvements through week 24.⁴

• Week 2: Patients treated with zasocitinib experienced greater reductions from baseline in weekly mean Psoriasis Symptoms and Signs Diary (PSSD) symptom scores, including itch, versus placebo (nominal p<0.001) and apremilast (nominal p<0.05 in LATITUDE PsO 3002).⁴
• Week 4: More patients treated with zasocitinib achieved Dermatology Life Quality Index (DLQI) 0/1, indicating psoriasis had no effect on their quality of life, versus placebo (nominal p<0.01 and p<0.001 in LATITUDE PsO 3001 and 3002, respectively) and apremilast (nominal p<0.01 in LATITUDE PsO 3002).⁴

The safety and tolerability profile of zasocitinib remained consistent across psoriasis studies.^2-5

"Psoriasis affects patients in ways that extend well beyond visible skin lesions. Persistent plaques, uncontrolled itch and the unpredictability of flares can have a profound impact on sleep, daily activities and overall well-being, while the ongoing demands of managing the disease can place an additional burden on patients,” said Linda Stein Gold, M.D., Director of Dermatology Clinical Research at Henry Ford Health in Detroit and principal investigator for the LATITUDE Atlas study. "The data from the Phase 3 trials provide a more complete picture of once-daily oral zasocitinib, demonstrating rapid, durable and consistent skin clearance alongside meaningful improvements in itch and quality of life. Together, these findings underscore the potential of zasocitinib to deliver multiple outcomes that matter to patients and clinicians.”

Q&A:
How do these results build on previously reported data?​
The results presented at the EADV Congress 2026 build on previously reported Phase 3 LATITUDE PsO 3001 and 3002 findings that showed rapid and durable skin clearance, including in hard-to-treat and high-impact sites (e.g., scalp, palms and soles, nails), and a consistent safety profile with zasocitinib.^5,6 The totality of evidence reinforces the potential of zasocitinib to deliver rapid, durable and consistent skin clearance in a convenient once-daily pill.^2-6

Over what two oral psoriasis treatment classes has zasocitinib demonstrated superior efficacy?
Zasocitinib demonstrated statistical superiority versus deucravacitinib, a first-generation TYK2 inhibitor, across the primary and all key secondary efficacy endpoints in the Phase 3 head-to-head LATITUDE Atlas (TAK-279 PsO 3004) study and versus apremilast, a phosphodiesterase 4 (PDE4) inhibitor, across all key secondary efficacy endpoints in the pivotal Phase 3 LATITUDE PsO 3001 and 3002 studies.^2-5 By demonstrating superior efficacy versus two distinct oral therapeutic classes, these data reinforce zasocitinib’s potential to redefine expectations for oral psoriasis treatment.^2-5

What are the next steps for zasocitinib?
Zasocitinib is currently under review by the U.S. Food and Drug Administration and European Medicines Agency for the treatment of moderate-to-severe plaque psoriasis. Takeda plans to submit additional applications to global regulatory authorities in an effort to bring zasocitinib to people living with psoriasis across the world.

Zasocitinib is also being evaluated in Phase 3 studies in psoriatic arthritis and Phase 2 studies in Crohn’s disease, ulcerative colitis, vitiligo and hidradenitis suppurativa.^7-12

About Plaque Psoriasis
Psoriasis is a chronic, systemic immune-mediated inflammatory disease characterized by itchy, painful, disfiguring and disabling skin lesions that impact one’s physical, emotional and psychological well-being.^13-16 Globally, an estimated 66.4 million people are living with psoriasis, and about 80-90% of those have plaque psoriasis.^17,18 Persistent itch, the appearance and location of skin lesions — especially in highly visible or high-impact sites — and related comorbidities, like psoriatic arthritis, play a major role in reducing quality of life and can lead to significant impacts on daily living.^15,16 Psoriasis is also a heterogeneous disease driven by complex, interconnected immune pathways, genetics and environmental factors that differ across patients and over time, leading to variability in disease course, symptoms and treatment response.^19-22

About Zasocitinib (TAK-279)
Zasocitinib is an investigational, next-generation, highly selective and potent oral tyrosine kinase 2 (TYK2) inhibitor that maintains 24-hour inhibition of IL-23 plus other core disease-driving immune pathways.^1,23-26 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.^2-5 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.^1,23 Takeda is currently evaluating the safety and efficacy of zasocitinib in Phase 3 studies in psoriatic arthritis and Phase 2 studies in Crohn’s disease, ulcerative colitis, vitiligo and hidradenitis suppurativa.^7-12 Zasocitinib is an investigational compound that has not been approved for use by any regulatory authority.

About Tyrosine Kinase 2 (TYK2) Inhibitors
TYK2 is a central mediator of core inflammatory pathways in psoriasis — IL-23/IL-17 axis and type I interferon signaling — making it a promising target, as inhibition of a single pathway may not fully control disease for every patient.^21,25,27TYK2 is an intracellular enzyme and member of the Janus kinase (JAK) protein family.^21,23 However, TYK2 is distinct from JAK1, 2 and 3 as it primarily regulates immune responses, whereas JAK1, 2 and 3 regulate broader biological processes such as lipid metabolism and hematopoiesis.^21,23 Highly selective allosteric inhibition of TYK2, with minimal inhibition of JAK1, 2 and 3, is a promising therapeutic approach to target immune-mediated inflammation.²⁸

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.²⁹ The study enrolled 606 participants, who received zasocitinib 30 mg once daily or deucravacitinib 6 mg once daily up to week 16.²⁹ 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.²⁹ The primary endpoint was the percentage of participants achieving PASI 100 at week 16.²⁹

About the Phase 3 LATITUDE PsO 3001 and 3002 Studies
The Phase 3 LATITUDE PsO 3001 (NCT06088043) and 3002 (NCT06108544) studies are global, multicenter, randomized, double-blind, placebo- and active comparator-controlled studies to evaluate the efficacy, safety and tolerability of zasocitinib in adult patients with moderate-to-severe plaque psoriasis.^30,31 The studies were conducted in 21 countries, with LATITUDE PsO 3001 enrolling 693 participants and LATITUDE PsO 3002 enrolling 1,108 participants, respectively.^30,31 The co-primary endpoints were the proportion of zasocitinib-treated patients achieving sPGA 0/1 and PASI 75 response compared to placebo at week 16.^30,31 Ranked (key) secondary endpoints included comparisons versus placebo (week 16) and apremilast (week 16 and week 24).^30,31

About Takeda
Takeda is focused on creating better health for people and a brighter future for the world. We aim to discover and deliver life-transforming treatments in our core therapeutic and business areas, including gastrointestinal and inflammation, rare diseases, plasma-derived therapies, oncology, neuroscience and vaccines. Together with our partners, we aim to improve the patient experience and advance a new frontier of treatment options through our dynamic and diverse pipeline. As a leading values-based, R&D-driven biopharmaceutical company headquartered in Japan, we are guided by our commitment to patients, our people and the planet. Our employees in approximately 80 countries and regions are driven by our purpose and are grounded in the values that have defined us for more than two centuries. For more information, visit www.takeda.com.

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References:

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