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Abstract Number: 1131

Zasocitinib (TAK-279), a Selective Oral Tyrosine Kinase 2 Inhibitor, Reduces Body Surface Area Involvement in a Phase 2b Trial in Moderate-to-Severe Plaque Psoriasis

Vivian Laquer1, Leon Kircik2, Neil Sadick3, Jamie Weisman4, Yiwei Zhao5, Jessamyn Blau5, Wenwen Zhang6, Jonathan Uy5, Warren Winkelman6 and Melinda Gooderham7, 1First OC Dermatology Research, Fountain Valley, CA, 2Icahn School of Medicine at Mount Sinai, New York, NY, 3Weill Cornell Medical College, New York, NY, 4Piedmont Atlanta, Atlanta, GA, 5Takeda Development Center Americas, Inc., Cambridge, MA, 6Takeda Development Center Americas, Inc., Cambridge, 7SKiN Centre for Dermatology and Probity Medical Research, Peterborough, ON, Canada

Meeting: ACR Convergence 2024

Keywords: Dermatology, Miscellaneous Rheumatic and Inflammatory Diseases, Randomized Trial

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Session Information

Date: Sunday, November 17, 2024

Title: Miscellaneous Rheumatic & Inflammatory Diseases Poster II

Session Type: Poster Session B

Session Time: 10:30AM-12:30PM

Background/Purpose: Zasocitinib (TAK-279) is a highly selective, allosteric, oral inhibitor of tyrosine kinase 2 (TYK2). TYK2 mediates signaling from cytokines involved in the pathogenesis of psoriasis and other immune-mediated inflammatory diseases.1,2 In a recent phase 2b trial in patients with moderate-to-severe psoriasis (NCT04999839), zasocitinib was well tolerated and demonstrated safety and efficacy with greater skin clearance at doses ≥ 5 mg compared with placebo, with the two highest doses (15 mg and 30 mg) showing the strongest responses at Week 12.3 This analysis further evaluated the efficacy of the 15 mg and 30 mg doses of zasocitinib in this study using body surface area (BSA) involvement.

Methods: In this randomized, multicentre, double-blind, placebo-controlled trial, patients with moderate-to-severe plaque psoriasis were randomized 1:1:1:1:1 to receive oral zasocitinib (2 mg, 5 mg, 15 mg or 30 mg) or placebo, once daily for 12 weeks. BSA outcome measures assessed at Week 12 were mean change in BSA from baseline, mean percentage change in BSA from baseline and the proportion of patients achieving a BSA threshold of ≤ 1% by visit. Mean change in BSA from baseline was pre-specified.

Results: Baseline mean (standard deviation [SD]) percentage BSA was generally consistent across zasocitinib 15 mg (n=53; 18.3 [10.3]), zasocitinib 30 mg (n=52; 22.2 [14.3]) and placebo (n=52; 21.3 [13.6]) groups. Mean percentage BSA decreased as early as Week 2 and continued to decrease throughout follow-up in the zasocitinib groups, whereas scores slightly decreased in the placebo group. At Week 12, mean (SD) percentage BSA was 4.4 (5.3) (least-squares [LS] mean change: −14.7; LS mean percentage change: −72.9%) in the 15 mg group, 6.5 (12.5) (LS mean change: −15.7; LS mean percentage change: −73.1%) in the 30 mg group and 18.2 (13.6) (LS mean change: −4.0; LS mean percentage change: −19.3%) in the placebo group (p < 0.001 for both doses versus placebo) (Figure 1). From Week 8 onwards, a higher proportion of patients achieved a BSA threshold of ≤ 1% in the zasocitinib 15 mg and 30 mg groups compared with the placebo group (35.8% and 44.2% versus 0% at Week 12, respectively) (Table 1).

Conclusion: Patients with moderate-to-severe plaque psoriasis who received the two highest doses of zasocitinib (15 mg and 30 mg) in the phase 2b trial achieved greater reductions in BSA than patients who received placebo over 12 weeks. Further investigation of the efficacy and safety of zasocitinib in phase 3 studies in psoriasis is ongoing (NCT0608804; NCT06108544).

References:

1. Leit S et al. J Med Chem 2023;66:10473–96.

2.  Rusiñol L, Puig L. Int J Mol Sci 2023;24:3391.

3.  Armstrong A et al. Oral presentation presented at the Annual Meeting of the American Academy of Dermatology, March 17–21, 2023, New Orleans, LA, USA.

Supporting image 1

Supporting image 2


Disclosures: V. Laquer: AbbVie, 5, Acelyrin, 5, Acrotech, 5, Amgen, 5, Arcutis, 5, Argenx, 5, Aslan, 5, Biofrontera, 5, Bristol-Myers Squibb(BMS), 5, Cara Therapeutics, 5, Dermavant, 5, Eli Lilly, 5, Galderma, 5, Horizon Therapeutics, 5, Incyte, 5, Janssen, 5, LEO Pharma, 5, Novartis, 5, Padagis, 5, Pfizer, 5, Q32, 5, Rapt, 5, Sun, 5, UCB, 5, Ventyx, 5; L. Kircik: Abbott Laboratories, 1, 2, 6, AbbVie, 1, 2, 6, Allergan, 1, 2, 6, Almirall, 1, 2, 6, Amgen, 1, 2, 6, Arcutis, 1, 2, 6, Biogen Idec, 1, 2, 6, Boehringer Ingelheim, 1, 2, 6, Breckinridge Pharma, 1, 2, 6, Bristol Myers Squibb, 1, 2, 6, Celgene, 1, 2, 6, Cellceutix, 1, 2, 6, Centocor, 1, 2, 6, Cipher, 1, 2, 6, Combinatrix, 1, 2, 6, Connetics, 1, 2, 6, Coria, 1, 2, 6, Dermavant, 1, 2, 6, Dermira, 1, 2, 6, Dow Pharmaceutical Sciences, 1, 2, 6, Dr. Reddy’s Lab, 1, 2, 6, Eli Lilly, 1, 2, 6, Galderma, 1, 2, 6, Genentech, 1, 2, 6, GlaxoSmithKlein(GSK), 1, 2, 6, Idera, 1, 2, 6, Incyte, 1, 2, Janssen, 1, 2, Johnson & Johnson, 1, 2, 6, Leo Pharma, 1, 2, 6, Lilly, 1, 2, Maruho, 1, 2, 6, Medicis, 1, 2, 6, Merck, 1, 2, 6, Merck Serono, 1, 2, 6, Nimbus, 1, 2, 6, Novartis, 1, 2, 6, Pfizer, 1, 2, 6, PharmaDerm, 1, 2, 6, Promius, 1, 2, 6, Sanofi Genzyme, 1, 2, Stiefel Laboratories, 1, 2, 6, Sun Pharma, 1, 2, 6, Taro, 1, 2, 6, UCB, 1, 2, 6, Valeant, 1, 2, 6, Ventyx, 1, 2, 6, XenoPort, 1, 2, 6; N. Sadick: AbbVie, 1, 2, 4, 6, 7, 11, Aclaris Therapeutics Inc., 1, 2, 4, 6, 7, 11, Acorn Biolabs, 1, 2, 4, 6, 7, 11, Advalight, 1, 2, 4, 6, 7, 11, Allergan Inc., 1, 2, 4, 6, 7, 11, Alma Lasers Inc., 1, 2, 4, 6, 7, 11, American Academy of Dermatology, 1, 2, 4, 6, 7, 11, American Hair Research Society, 1, 2, 4, 6, 7, 11, American Society of Dermatologic Surgery, 1, 2, 4, 6, 7, 11, Amgen, 1, 2, 4, 6, 7, 11, ASDS, 1, 2, 4, 6, 7, 11, ASLAN, 1, 2, 4, 6, 7, 11, Aurigene Discovery Technologies Ltd., 1, 2, 4, 6, 7, 11, Bausch Health, 1, 2, 4, 6, 7, 11, Bellus Health, 1, 2, 4, 6, 7, 11, Biorasi LLC, 1, 2, 4, 6, 7, 11, Biosion, 1, 2, 4, 6, 7, 11, Bristol-Myers Squibb(BMS), 1, 2, 4, 6, 7, 11, Canfield Scientific Inc., 1, 2, 4, 6, 7, 11, Cara Therapeutics, 1, 2, 4, 6, 7, 11, Castle Biosciences, 1, 2, 4, 6, 7, 11, Celgene, 1, 2, 4, 6, 7, 11, Cell Research Corp, 1, 2, 4, 6, 7, 11, Concert Pharmaceuticals, 1, 2, 4, 6, 7, 11, Cutera Inc., 1, 2, 4, 6, 7, 11, Derm Advance, 1, 2, 4, 6, 7, 11, Derm Tech International, 1, 2, 4, 6, 7, 11, Dermira, 1, 2, 4, 6, 7, 11, Distinct Dermatology, 1, 2, 4, 6, 7, 11, Dr Reddy’s Laboratory, 1, 2, 4, 6, 7, 11, Eirion Therapeutics, 1, 2, 4, 6, 7, 11, Eli Lilly, 1, 2, 4, 6, 7, 11, EndyMed Medical Inc., 1, 2, 4, 6, 7, 11, Foundation for Research & Education of Dermatology, 1, 2, 4, 6, 7, 11, Galderma USA, 1, 2, 4, 6, 7, 11, Gerson Lehrman Group, 1, 2, 4, 6, 7, 11, Highlightll Pharmaceutical, 1, 2, 4, 6, 7, 11, Incyte Corporation, 1, 2, 4, 6, 7, 11, Informa, 1, 2, 4, 6, 7, 11, Janssen Pharmaceuticals Inc., 1, 2, 4, 6, 7, 11, Kadmon Corporation LLC, 1, 2, 4, 6, 7, 11, Kimera Labs Inc., 1, 2, 4, 6, 7, 11, LCN Consulting, 1, 2, 4, 6, 7, 11, LEO Pharma, 1, 2, 4, 6, 7, 11, Lumenis Be Ltd., 1, 2, 4, 6, 7, 11, Lumisque, 1, 2, 4, 6, 7, 11, Merz Aesthetics, 1, 2, 4, 6, 7, 11, NFlection Therapeutics Inc., 1, 2, 4, 6, 7, 11, Nimbus Therapeutics, 1, 2, 4, 6, 7, 11, NUMAB Therapeutics AG, 1, 2, 4, 6, 7, 11, Nutrafol, 1, 2, 4, 6, 7, 11, Pfizer, 1, 2, 4, 6, 7, 11, Philips Healthcare, 1, 2, 4, 6, 7, 11, PPD Inc., 1, 2, 4, 6, 7, 11, RegenLab, 1, 2, 4, 6, 7, 11, Rho Inc., 1, 2, 4, 6, 7, 11, Scientus Pharma Inc., 1, 2, 4, 6, 7, 11, Suzhou Connect Biopharmaceuticals LTD, 1, 2, 4, 6, 7, 11, Taylor & Francis, 1, 2, 4, 6, 7, 11, Union Therapeutics, 1, 2, 4, 6, 7, 11, Vanda Pharmaceuticals Inc., 1, 2, 4, 6, 7, 11, Venus Concept, 1, 2, 4, 6, 7, 11, Viora, 1, 2, 4, 6, 7, 11, Vydence Medical, 1, 2, 4, 6, 7, 11; J. Weisman: AbbVie, 5, Alumis, 5, Amgen, 5, Boehringer Ingleheim, 5, Bristol Myers Squibb, 5, Dermira, 5, Eli Lilly, 5, Galderma, 5, Merck, 5, Pfizer, 5, Regeneron, 5, Sanofi, 5, Takeda, 5; Y. Zhao: Takeda, 3, 11; J. Blau: Takeda, 3, 11; W. Zhang: Takeda, 3, 11; J. Uy: Takeda, 3, 11; W. Winkelman: Takeda, 3, 11; M. Gooderham: AbbVie, 1, 2, 6, Akros, 1, 2, 6, Amgen, 1, 2, 6, AnaptysBio, 1, 2, 6, Apogee, 1, 2, 6, Arcutis, 1, 2, 6, Aristea, 1, 2, 6, Bausch Health, 1, 2, 6, Boehringer Ingelheim, 1, 2, 6, Bristol Myers Squibb, 1, 2, 6, Celgene, 1, 2, 6, Dermavant, 1, 2, 6, Dermira, 1, 2, 6, Eli Lilly, 1, 2, 6, Galderma, 1, 2, 6, GSK, 1, 2, 6, Horizon, 1, 2, 6, Incyte, 1, 2, 6, Inmagene, 1, 2, 6, Janssen, 1, 2, 6, Kyowa Kirin, 1, 2, 6, LEO Pharma, 1, 2, 6, MedImmune, 1, 2, 6, Meiji, 1, 2, 6, Merck, 1, 2, 6, MoonLake, 1, 2, 6, Nimbus, 1, 2, 6, Novartis, 1, 2, 6, Pfizer, 1, 2, 6, Regeneron, 1, 2, 6, Roche, 1, 2, 6, Sanofi Genzyme, 1, 2, 6, Sun Pharma, 1, 2, 6, Takeda, 1, 2, 6, Tarsus, 1, 2, 6, UCB, 1, 2, 6, Union, 1, 2, 6, Ventyx, 1, 2, 6.

To cite this abstract in AMA style:

Laquer V, Kircik L, Sadick N, Weisman J, Zhao Y, Blau J, Zhang W, Uy J, Winkelman W, Gooderham M. Zasocitinib (TAK-279), a Selective Oral Tyrosine Kinase 2 Inhibitor, Reduces Body Surface Area Involvement in a Phase 2b Trial in Moderate-to-Severe Plaque Psoriasis [abstract]. Arthritis Rheumatol. 2024; 76 (suppl 9). https://acrabstracts.org/abstract/zasocitinib-tak-279-a-selective-oral-tyrosine-kinase-2-inhibitor-reduces-body-surface-area-involvement-in-a-phase-2b-trial-in-moderate-to-severe-plaque-psoriasis/. Accessed .
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