## Takeda’s Zasocitinib Shows Strong Efficacy in Phase 3 Psoriasis Trials, Poised for Regulatory Submission
**Osaka, Japan & Cambridge, Mass.** – Takeda announced compelling topline results from two pivotal Phase 3 studies evaluating zasocitinib (TAK-279), an oral tyrosine kinase 2 (TYK2) inhibitor, for the treatment of moderate-to-severe plaque psoriasis. The studies met all primary and ranked secondary endpoints, demonstrating zasocitinib’s potential to offer a convenient, once-daily oral therapy that can achieve significant skin clearance for patients.
The trials revealed that zasocitinib significantly outperformed placebo in achieving both static Physician Global Assessment (sPGA) 0/1 (clear or almost clear skin) and Psoriasis Area and Severity Index (PASI) 75 (a 75% reduction in psoriasis symptoms) by week 16. Notably, these improvements were observed as early as week 4 and continued to progress through week 24. Furthermore, a substantial proportion of patients achieved remarkable results, with over half reaching PASI 90 (90% skin improvement) and approximately 30% achieving PASI 100 (complete skin clearance) by week 16.
“Patients with psoriasis continue to seek oral treatments that are not only safe and effective but also deliver rapid relief,” stated Christophe Weber, President and CEO of Takeda. “These pivotal findings underscore zasocitinib’s potential to become a leading oral treatment option, offering patients the prospect of clear skin. This marks our third positive Phase 3 readout this year, highlighting the strength of our pipeline, with zasocitinib, oveporexton, and rusfertide all poised to make significant impacts on patient lives and commercial landscapes.”
The safety profile of zasocitinib in these Phase 3 studies was consistent with previous trials, demonstrating good tolerability. The most frequently reported adverse events through week 24 included upper respiratory tract infections, nasopharyngitis, and acne, with no new safety concerns emerging.
“It is incredibly rewarding to see our Phase 2 findings rigorously validated in Phase 3,” commented Dr. Andy Plump, President of R&D at Takeda. “The data showing over half of patients achieving PASI 90 and nearly a third reaching PASI 100 at week 16 reinforces our understanding of TYK2’s critical role in mediating key inflammatory pathways like IL-23, which are central to psoriasis. This selective inhibition holds significant promise for substantially reducing disease burden and offering the potential for complete skin clearance.”
Takeda plans to present these findings at upcoming medical congresses and intends to file a New Drug Application (NDA) with the U.S. Food and Drug Administration and other global regulatory authorities in fiscal year 2026.
Beyond plaque psoriasis, zasocitinib is being investigated in a head-to-head study against deucravacitinib, as well as in Phase 3 trials for psoriatic arthritis. Earlier-stage studies are also underway for Crohn’s disease and ulcerative colitis, indicating a broad therapeutic potential for this TYK2 inhibitor.
### Understanding the Metrics: PASI and sPGA
The clinical trial data relies on key metrics to quantify treatment efficacy:
* **Psoriasis Area and Severity Index (PASI):** This score quantifies the extent and severity of psoriasis. Investors closely monitor changes in PASI scores, as significant improvements signal a drug’s effectiveness, impacting regulatory approval and market projections.
* **PASI 75, PASI 90, and PASI 100:** These represent benchmarks of 75%, 90%, and 100% improvement in PASI scores, respectively. Achieving higher PASI levels indicates more substantial and visible patient outcomes, crucial for market differentiation and commercial success.
* **static Physician Global Assessment (sPGA):** A single-time, physician-rated score assessing overall disease severity. It serves as a rapid, standardized measure of treatment response and is a common endpoint in clinical trials, influencing regulatory decisions and market potential.
### The Science Behind Zasocitinib: Targeting TYK2
Zasocitinib is designed as a next-generation, highly selective oral inhibitor of Tyrosine Kinase 2 (TYK2). TYK2 is a crucial enzyme within the Janus kinase (JAK) family, playing a pivotal role in immune responses by mediating signaling pathways like Interleukin-23 (IL-23). These pathways are fundamental drivers of inflammatory conditions such as psoriasis and psoriatic arthritis.
The selectivity of zasocitinib for TYK2, with minimal impact on other JAK enzymes (JAK1, JAK2, JAK3), is a key aspect of its therapeutic approach. This targeted inhibition aims to effectively modulate immune-mediated inflammation while potentially mitigating the risks associated with broader JAK inhibition, which can affect various biological processes. This precision targeting could offer a favorable balance of efficacy and safety.
### About Plaque Psoriasis
Plaque psoriasis is a chronic, immune-mediated inflammatory disease affecting an estimated 64 million people globally, with 80-90% of cases being plaque psoriasis. It is characterized by the rapid multiplication of skin cells, leading to raised, red, and scaly patches that can cause significant itching, pain, and negatively impact patients’ mental health and quality of life. Current treatment paradigms are evolving, with a growing demand for oral therapies that offer convenience and significant symptom relief.
### About Takeda Pharmaceutical Company Limited
Takeda is a patient-focused, values-based, R&D-driven biopharmaceutical company headquartered in Japan. With a global presence and a history spanning over two centuries, Takeda is committed to discovering and delivering life-transforming treatments across its core therapeutic areas: gastrointestinal and inflammation, rare diseases, plasma-derived therapies, oncology, neuroscience, and vaccines. The company actively pursues innovative research and development, collaborating with partners to advance new therapeutic options and improve patient experiences worldwide.
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