Takeda’s Zasocitinib Significantly Outperforms Deucravacitinib in Head-to-Head Phase 3 Psoriasis Study, Promising to Redefine Oral Treatment Expectations

Takeda (TSE:4502/NYSE:TAK) announced 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.

Perspectives on head-to-head zasocitinib study
“In this head-to-head study, zasocitinib clearly demonstrated superior skin clearance compared with deucravacitinib, highlighting clinically meaningful differences within the oral treatment class,” said Linda Stein Gold, M.D., Director of Dermatology Clinical Research at Henry Ford Health and principal investigator for the LATITUDE Atlas study. “As expectations for oral therapies continue to rise, these findings support the potential of zasocitinib to help transform what patients and physicians can expect from an oral option in plaque psoriasis.”

“These head-to-head results build on the strong efficacy seen across our Phase 3 program, with more than 35% of zasocitinib-treated patients achieving complete skin clearance (PASI 100) at week 16 – more than 2.5 times the response rate for deucravacitinib – and separation from the deucravacitinib curve as early as week 8,” said Chinwe Ukomadu, MD, PhD, senior vice president and head, Gastrointestinal & Inflammation Therapeutic Area Unit at Takeda. “Together, these findings reinforce the promise of zasocitinib to deliver rapid and durable skin clearance in a convenient once-daily pill and demonstrate the transformative potential of highly selective and potent TYK2 inhibition for patients suffering with plaque psoriasis.”

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, systemic immune-mediated inflammatory disease characterized by itchy, painful, disfiguring and disabling skin lesions that impact one’s physical, emotional and psychological wellbeing.^1-7 Globally, an estimated 64 million people are living with psoriasis and about 80-90% of those have plaque psoriasis.^8-9 Persistent itch, the appearance and location of skin lesions – especially in highly visible or sensitive areas – and related comorbidities, like psoriatic arthritis, play a major role in reducing quality of life and can lead to significant impacts on daily living.^4-7 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.^10-14

About Zasocitinib (TAK-279)
Zasocitinib is an investigational, next-generation, highly selective and potent oral TYK2 inhibitor that maintains 24-hour inhibition of IL-23 plus other core disease-driving immune pathways.^15-19 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.²⁰ 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.^15-16 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 (HS).^21-27 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.²⁸ The study enrolled 606 participants, who received zasocitinib 30 mg once daily or deucravacitinib 6 mg once daily up to week 16.²⁸ 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 16.²⁸

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.^14,18,29TYK2 is an intracellular enzyme and member of the Janus kinase (JAK) protein family.^14-15 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, which can be linked to cardiovascular risks and blood disorders when disrupted.^14-15,30 Highly selective allosteric inhibition of TYK2, with minimal inhibition of JAK1, 2 and 3, is a promising therapeutic approach to target immune-mediated inflammation while potentially avoiding risks associated with inhibition of other members of the JAK family.¹⁹

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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