Last updated: January 2, 2025
Introduction to TAK-279
TAK-279, formerly known as NDI-034858, is a highly selective, oral allosteric tyrosine kinase 2 (TYK2) inhibitor developed by Takeda. This drug candidate is being evaluated for the treatment of multiple autoimmune diseases, including psoriasis, psoriatic arthritis, and other immune-mediated inflammatory conditions.
Clinical Trials and Efficacy
Phase 2b Trials in Psoriasis
In a Phase 2b clinical trial, TAK-279 demonstrated significant efficacy in patients with moderate-to-severe plaque psoriasis. The study showed that a statistically significant greater proportion of patients treated with TAK-279 achieved Psoriasis Area and Severity Index (PASI) 75, 90, and 100 compared to the placebo group at 12 weeks. Specifically, 44%, 68%, and 67% of patients in the 5mg, 15mg, and 30mg dosing arms, respectively, achieved PASI 75, while 21%, 45%, and 46% achieved PASI 90, and 10%, 15%, and 33% achieved PASI 100[1].
Phase 2b Trials in Psoriatic Arthritis
TAK-279 also showed promising results in a Phase 2b trial for active psoriatic arthritis. The study met its primary endpoint, with 53.3% and 54.2% of patients in the 15mg and 30mg dosing arms, respectively, achieving an American College of Rheumatology 20 (ACR 20) response compared to 29.2% in the placebo arm at week 12[3][4].
Safety and Tolerability
In both Phase 1 and Phase 2b studies, TAK-279 has demonstrated a good tolerability profile and a pharmacokinetic profile that allows for once-daily solid oral dosing. The safety profile of TAK-279 has been consistent with the Phase 2b psoriasis study, indicating a favorable safety profile for the drug candidate[1][3][4].
Future Development Plans
Based on the positive results from the Phase 2b trials, Takeda plans to initiate Phase 3 studies for TAK-279 in both psoriasis and psoriatic arthritis. Additionally, the development of TAK-279 is being advanced in other immune-mediated diseases, including Crohn’s disease, ulcerative colitis, and systemic lupus erythematosus (SLE)[1][3][4].
Market Projection
Market Potential
TAK-279 is part of Takeda's high-value, late-stage pipeline, which is expected to deliver significant market opportunities. The late-stage pipeline, including TAK-279, has the potential to generate peak revenues of $10 billion to $20 billion[2].
Competitive Landscape
The psoriasis market is expected to show significant growth by 2034, driven by increasing prevalence and the development of new treatments. TAK-279, with its high selectivity for TYK2 and promising clinical results, is positioned to become a leading treatment option in this market. Other late-stage therapies in development for psoriasis include imsidolimab by AnaptysBio and sonelokimab by MoonLake Immunotherapeutics[5].
Regulatory Filings
Takeda expects to report Phase 3 results for TAK-279 in psoriasis in 2025, with regulatory filings anticipated in fiscal years 2025 and 2026. Additional filings for psoriatic arthritis and other indications are planned for fiscal years 2027 through 2029[2].
Key Takeaways
- Efficacy: TAK-279 has shown significant efficacy in Phase 2b trials for both psoriasis and psoriatic arthritis.
- Safety: The drug has a favorable safety and tolerability profile.
- Development Plans: Phase 3 studies are planned for psoriasis and psoriatic arthritis, with additional indications being explored.
- Market Potential: TAK-279 is expected to contribute to Takeda's late-stage pipeline, potentially generating significant revenues.
- Competitive Landscape: TAK-279 is well-positioned in a growing psoriasis market with its unique mechanism of action.
FAQs
What is TAK-279?
TAK-279 is a highly selective, oral allosteric tyrosine kinase 2 (TYK2) inhibitor being developed by Takeda for the treatment of various autoimmune diseases.
What are the current clinical trial stages for TAK-279?
TAK-279 has completed Phase 2b trials for psoriasis and psoriatic arthritis and is set to enter Phase 3 studies for these indications.
What are the key efficacy results for TAK-279 in psoriasis?
In Phase 2b trials, TAK-279 showed a statistically significant greater proportion of patients achieving PASI 75, 90, and 100 compared to placebo at 12 weeks[1].
What other indications is TAK-279 being explored for?
In addition to psoriasis and psoriatic arthritis, TAK-279 is being developed for Crohn’s disease, ulcerative colitis, and systemic lupus erythematosus (SLE)[1][3][4].
When are the Phase 3 results for TAK-279 expected?
Phase 3 results for TAK-279 in psoriasis are expected to be reported in 2025, with regulatory filings anticipated in fiscal years 2025 and 2026[2].
Sources
- Takeda Announces Positive Results in Phase 2b Study of Investigational TAK-279. Takeda.
- Takeda Spotlights High-Value, Late-Stage Pipeline Accelerating the Development of Potential Transformative Treatments for Patients in Multiple Therapeutic Areas. Business Wire.
- Takeda Announces Late-Breaking Data from Phase 2b Study of TAK-279, an Investigational Oral Once-Daily TYK2 Inhibitor, in Patients with Active Psoriatic Arthritis at American College of Rheumatology Convergence Annual Meeting. Business Wire.
- Takeda Announces Late-Breaking Data from Phase 2b Study of TAK-279, an Investigational Oral Once-Daily TYK2 Inhibitor, in Patients with Active Psoriatic Arthritis at American College of Rheumatology Convergence Annual Meeting. BioSpace.
- Psoriasis Market to Register Incremental Growth by 2034, Predicts DelveInsight. PR Newswire.
