EX-99.2 3 presentation.htm EX-99.2 presentation
Zasocitinib IR Event Phase 3 Psoriasis Data Presented at AAD March 28th, 2026 ET / March 29th, 2026 JST This material is prepared and distributed solely for the purpose of providing information about Takeda's management or business to shareholders, investors, and analysts, and is not intended to induce purchase or prescription of any specific drugs and other products. This material is not intended for healthcare professionals, patients, or other persons other than those mentioned above. This material is prohibited from being used by persons other than those mentioned above and for the purpose other than one mentioned above. Photo: IFPA | All the Colors We Are


 
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Opening Remarks Julie Kim, CEO-Elect Phase 3 Psoriasis Results Chinwe Ukomadu, Head of GI&I Therapeutic Area Market Opportunity Rhonda Pacheco, President, U.S. Business Unit; U.S. Country Head Question & Answer Session AGENDA 1. 2. 3. 4.


 
Preparing to launch 3 transformative medicines in the next 15 months setting Takeda on a new growth trajectory 4 Oveporexton Narcolepsy Type 1 Rusfertide Polycythemia Vera Zasocitinib Psoriasis Expected launch 2026 (H2) Expected launch 2026 (H2) Expected launch 2027 (H1) First orexin agonist to NDA submission with compelling efficacy across the broad spectrum of NT1 symptoms Primed to trigger a paradigm shift in the treatment of NT1 Hepcidin mimetic delivering durable & sustained hematocrit control addressing major unmet need Set to revolutionize outcomes at each step in the treatment landscape Next-generation, highly selective oral TYK2 inhibitor delivering rapid and durable skin clearance in a convenient once-daily pill Poised to be a leading oral option in an expanding oral market Estimated launch timings are all pending regulatory approval. Breakthrough Designation Fast Track Designation Orphan Drug Designation


 
Zasocitinib: Poised to be a leading oral treatment option for patients with psoriasis – significantly expanding the oral market 1 32 Convenient once-daily pill without fasting restrictions Rapid and durable skin clearance, with no new safety signals Next-generation, highly selective oral TYK2 inhibitor Zasocitinib U.S. and global filings on track to start in FY26 5


 
Zasocitinib Phase 3 Psoriasis Results


 
Zasocitinib: Next-generation, highly selective oral TYK2 inhibitor1,2 7 • More than 1 millionfold greater binding selectivity for TYK2 versus JAK1, JAK2 and JAK31,2 • Maintains 24-hour inhibition of IL-23 plus other core disease-driving immune pathways without any inhibition of JAK1, JAK2 and JAK3 pathways.2,3 • Well tolerated and efficacious in a phase 2b trial in patients with moderate-to-severe plaque psoriasis4 Objective: To evaluate the efficacy and safety of zasocitinib in adults with moderate-to-severe plaque psoriasis in two pivotal phase 3 studies: LATITUDE-PsO-3001 (NCT06088043) and LATITUDE-PsO-3002 (NCT06108544) IFN, interferon; IL, interleukin; JAK, Janus kinase; TYK, tyrosine kinase 1. Leit S et al. J Med Chem 2023;66:10473–96; 2. Mehrotra S et al. J Invest Dermatol 2025;146:214–22; 3. Rusiñol L and Puig L. Int J Mol Sci 2023;24:3391. 4. Armstrong A et al. JAMA Dermatol 2024;160:1066–74.


 
LATITUDE-PsO-3001 and 3002 were randomized, multicenter, double-blind, placebo- and apremilast-controlled phase 3 trials 8 Endpoints Co-primary endpoints at Week 16 (versus placebo): • sPGA 0/1a • PASI 75 Key secondary endpoints (versus placebo or apremilast) included: • PASI 75 at Week 4 • sPGA 0, PASI 75/90/100 or DLQI 0/1b at Week 16/24 • sPGA 0/1 or PASI 75 maintenance at Week 60 Safety endpoints included: • TEAEs; laboratory parameters Eligibility • Adults (≥ 18 years) • Plaque psoriasis diagnosis for ≥ 6 months prior to screening • PASI ≥ 12, sPGA ≥ 3, ≥ 10% BSA • Candidate for phototherapy or systemic therapy aWith a ≥ 2-point decrease from baseline. bWith a baseline DLQI score ≥2. BSA, body surface area; DLQI, Dermatology Life Quality Index; F/U, follow-up; PASI, Psoriasis Area and Severity Index; sPGA, static Physician’s Global Assessment; TEAE, treatment-emergent adverse events.


 
Baseline demographics and characteristics were generally similar across treatment arms in each study 9 LATITUDE-PsO-3001 LATITUDE-PsO-3002 Zasocitinib (n = 416) Apremilast (n = 137) Placebo (n = 140) Zasocitinib (n = 555) Apremilast (n = 276) Placebo (n = 277) Age, years 43.8 (13.26) 46.0 (14.10) 45.3 (13.54) 45.8 (13.33) 46.1 (13.37) 46.5 (13.19) Sex, male, n (%) 295 (70.9) 95 (69.3) 93 (66.4) 367 (66.1) 187 (67.8) 188 (67.9) Race, White, n (%) 255 (61.3) 88 (64.2) 87 (62.1) 472 (85.0) 233 (84.4) 240 (86.6) BMI, kg/m2 29.7 (6.8) 28.5 (6.3) 28.2 (6.5) 30.2 (6.8) 30.1 (6.5) 30.4 (7.2) Psoriasis duration, median (range) yearsa 13.6 (0.6–62.4) 14.0 (0.6–71.3) 12.5 (0.6–59.3) 15.1 (0.5–69.2) 16.5 (0.6–60.5) 15.1 (0.6–65.9) PASI score 19.7 (7.5) 20.5 (9.0) 20.3 (7.4) 21.3 (9.3) 21.4 (8.6) 21.1 (8.5) sPGA score 3 (moderate), n (%) 329 (79.1) 116 (84.7) 112 (80.0) 473 (85.2) 237 (85.9) 228 (82.3) 4 (severe), n (%) 85 (20.4) 21 (15.3) 28 (20.0) 80 (14.4) 39 (14.1) 48 (17.3) BSA, % 24.0 (14.0) 25.8 (15.9) 24.2 (14.4) 27.9 (17.9) 27.8 (16.5) 27.0 (16.3) DLQI scoreb 12.7 (7.2) 11.1 (6.5) 12.2 (7.3) 11.6 (7.2) 11.5 (6.7) 12.2 (7.4) Bio-experienced, n (%) 141 (33.9) 40 (29.2) 45 (32.1) 155 (27.9) 80 (29.0) 83 (30.0) Data are mean (SD) unless otherwise stated. aData missing for one patient receiving zasocitinib (LATITUDE-PsO-3002). bData missing for three patients receiving zasocitinib and one receiving apremilast (LATITUDE-PsO-3001), and for three patients receiving zasocitinib, one patient receiving apremilast, and four patients receiving placebo (LATITUDE-PsO-3002). BMI, body mass index; BSA, body surface area; DLQI, Dermatology Life Quality Index; PASI, Psoriasis Area and Severity Index; SD, standard deviation; sPGA, static Physician’s Global Assessment.


 
LATITUDE-PsO-3002 Zasocitinib met the co-primary endpoints in both studies (sPGA 0/1 and PASI 75 versus placebo at Week 16) 10 PASI 75sPGA 0/1a PASI 75sPGA 0/1a aWith a ≥ 2-point decrease from baseline. Number of patients based on the full analysis set with non-responder imputation. LATITUDE-PsO-3001: Zasocitinib (n = 416), apremilast (n = 137), placebo (n = 140). LATITUDE-PsO-3002: Zasocitinib (n = 555), apremilast (n = 276), placebo (n = 277). P values for comparison versus apremilast (in blue) and versus placebo (in gray) based on a stratified Cochran–Mantel–Haenszel test: ***p < 0.001. CI, confidence interval; PASI, Psoriasis Area and Severity Index; sPGA, static Physician’s Global Assessment. LATITUDE-PsO-3001


 
LATITUDE-PsO-3002 LATITUDE-PsO-3001 Rapid skin clearance as early as week 4 with zasocitinib 11 PASI 75 PASI 75sPGA 0/1a aWith a ≥ 2-point decrease from baseline. Number of patients based on the full analysis set with non-responder imputation. LATITUDE-PsO-3001: Zasocitinib (n = 416), apremilast (n = 137), placebo (n = 140). LATITUDE-PsO-3002: Zasocitinib (n = 555), apremilast (n = 276), placebo (n = 277). P values for comparison versus apremilast (in blue) and versus placebo (in gray) based on a stratified Cochran–Mantel–Haenszel test: ***p < 0.001, ̂ ^ nominal p<0.01 CI, confidence interval; PASI, Psoriasis Area and Severity Index; sPGA, static Physician’s Global Assessment. *** 17% 6% 4% ^^ 23% 16% 5% ^^ 21% 12% 9% ^^^^ sPGA 0/1a 31% 18% 9% ^^^^


 
Zasocitinib led to greater proportions of patients achieving PASI 90 than apremilast or placebo as early as Week 4 12 Number of patients based on the full analysis set with non-responder imputation. LATITUDE-PsO-3001: Zasocitinib (n = 416), apremilast (n = 137), placebo (n = 140). LATITUDE-PsO-3002: Zasocitinib (n = 555), apremilast (n = 276), placebo (n = 277). P values for comparison versus apremilast (in blue) and versus placebo (in gray) based on a stratified Cochran–Mantel–Haenszel test: ***p < 0.001. CfB, change from baseline; CI, confidence interval; PASI, Psoriasis Area and Severity Index; BSA, body surface area. Baseline Week 16 PASI: 15.8 PASI: 0.7 (CfB 95.6%) PASI 90 Responder: Baseline BSA 25% LATITUDE-PsO-3001 LATITUDE-PsO-3002 PASI 90 PASI 90


 
Zasocitinib led to greater proportions of patients achieving clear skin versus apremilast or placebo as early as Week 8 13 sPGA 0 sPGA 0 PASI 100 PASI 100 Number of patients based on the full analysis set with non-responder imputation. LATITUDE-PsO-3001: Zasocitinib (n = 416), apremilast (n = 137), placebo (n = 140). LATITUDE-PsO-3002: Zasocitinib (n = 555), apremilast (n = 276), placebo (n = 277). P values for comparison versus apremilast (in blue) and versus placebo (in gray) based on a stratified Cochran–Mantel–Haenszel test: ***p < 0.001. CI, confidence interval; PASI, Psoriasis Area and Severity Index; sPGA, static Physician’s Global Assessment. LATITUDE-PsO-3002 LATITUDE-PsO-3001


 
LATITUDE-PsO-3001 Zasocitinib led to greater proportions of patients achieving clear skin versus apremilast or placebo as early as Week 8 14 Baseline PASI: 31.3 PASI: 0 Week 16 PASI 100 Responder: Baseline BSA 62% PASI 100 PASI 100 Number of patients based on the full analysis set with non-responder imputation. LATITUDE-PsO-3001: Zasocitinib (n = 416), apremilast (n = 137), placebo (n = 140). LATITUDE-PsO-3002: Zasocitinib (n = 555), apremilast (n = 276), placebo (n = 277). P values for comparison versus apremilast (in blue) and versus placebo (in gray) based on a stratified Cochran–Mantel–Haenszel test: ***p < 0.001. CI, confidence interval; PASI, Psoriasis Area and Severity Index; BSA, body surface area. LATITUDE-PsO-3002


 
Zasocitinib demonstrated superior improvement in DLQI versus apremilast or placebo as early as Week 4 15 LATITUDE-PsO-3002LATITUDE-PsO-3001 DLQI 0/1a DLQI 0/1a aBased on evaluable patients defined as a subset of full analysis set with a baseline DLQI score ≥2 (with nonresponder imputation). Number of evaluable patients for LATITUDE-PsO-3001: zasocitinib (n = 406), apremilast (n = 133), placebo (n = 133). Number of evaluable patients for LATITUDE-PsO-3002: zasocitinib (n = 525), apremilast (n = 263), placebo (n = 260). P values for comparison versus apremilast (in blue) and versus placebo (in gray) based on a stratified Cochran–Mantel–Haenszel test: ***p < 0.001. CI, confidence interval, DLQI, Dermatology Life Quality Index.


 
Zasocitinib was well tolerated with no new safety signals identified through Week 16 16 Day 0 to Week 16 TEAEs from LATITUDE-PsO-3001 and 3002a Zasocitinib (n = 970) Apremilast (n = 412) Placebo (n = 417) n %b, (95% CI)c n %b, (95% CI)c n %b, (95% CI)c Any TEAE 605 62.1 (59.0–65.1) 207​ 50.5 (45.7–55.4) 196​ 46.9 (42.0–51.7) Leading to discontinuation 31 3.2 (2.1–4.3)​ 11​ 2.6 (1.1–4.2) 3​ < 1 (0.0–1.6) SAE 29 3.0 (1.9–4.1) 6​ 1.5 (0.3–2.7) 2​ < 1 (0.1–1.7) Death 1d < 1 (0.0–0.6)d 0​ 0 (0.0–0.9)​ 0​ 0 (0.0–0.9)​ Most frequent TEAE (≥ 5%)e URTI 100 10.1 (8.2–12.0) 24​ 6.0 (3.7–8.3) 13​ 3.2 (1.5–4.8) Acne​ 62​ 6.5 (5.0–8.1) 3​ < 1 (0.0–1.7) 1​ < 1 (0.0–1.3) Nasopharyngitis​ 60 6.2 (4.7–7.7) 23​ 5.4 (3.2–7.5) 20​ 4.7 (2.7–6.6) Diarrhea​ 30​ 3.1 (2.0–4.2) 33​ 8.2 (5.5–10.9) 8​ 1.8 (0.6–3.1) Headache​ 27​ 2.8 (1.8–3.9) 26​ 6.3 (4.0–8.7) 8​ 1.9 (0.6–3.2) Nausea​ 20​ 2.1 (1.2–3.0) 23​ 5.5 (3.3–7.8) 5​ 1.2 (0.1–2.2) • No new safety signals observed through week 24 • Most TEAEs were mild or moderate • Laboratory parameters (e.g. lymphocytes, liver enzymes, lipids) demonstrated no clinically meaningful trends over time in both studies​ TEAEs were coded using MedDRA v28.1. aEvents starting while on initial treatment are included. bSample size adjusted incidence rate x 100. c95% Wald CI unless 0 events occur in either trial, in which case a 95% exact binomial CI is used. dDeath occurred 1 day after first dose date (unrelated to treatment). eMost frequently reported adverse events occurring in ≥ 5% of patients in any treatment group. CI, confidence interval; MedDRA, Medical Dictionary for Regulatory Activities; TEAE, treatment-emergent adverse event; SAE, serious adverse event; URTI, upper respiratory tract infection.


 
LATITUDE-PsO-3001 and 3002 were randomized, multicenter, double-blind, placebo- and apremilast-controlled phase 3 trials 17 Endpoints Co-primary endpoints at Week 16 (versus placebo): • sPGA 0/1a • PASI 75 Key secondary endpoints (versus placebo or apremilast) included: • PASI 75 at Week 4 • sPGA 0, PASI 75/90/100 or DLQI 0/1b at Week 16/24 • sPGA 0/1 or PASI 75 maintenance at Week 60 Safety endpoints included: • TEAEs; laboratory parameters Eligibility • Adults (≥ 18 years) • Plaque psoriasis diagnosis for ≥ 6 months prior to screening • PASI ≥ 12, sPGA ≥ 3, ≥ 10% BSA • Candidate for phototherapy or systemic therapy Randomized withdrawal 40 aWith a ≥ 2-point decrease from baseline. bWith a baseline DLQI score ≥2. BSA, body surface area; DLQI, Dermatology Life Quality Index; F/U, follow-up; PASI, Psoriasis Area and Severity Index; sPGA, static Physician’s Global Assessment; TEAE, treatment-emergent adverse events.


 
More than 90% of patients continuing zasocitinib at Week 40 maintained sPGA 0/1, PASI 75 and PASI 90 through Week 60 18 sPGA 0/1 PASI 75 LATITUDE-PsO-3002 randomized withdrawal Most (59%, 69% and 52%) patients re-randomized from zasocitinib to placebo at Week 40 maintained sPGA 0/1, PASI 75, and PASI 90, respectively, for an additional ~5 months PASI 90 91% Evaluable patients based on the full analysis set for randomized withdrawal with nonresponder imputation. Number of patients for sPGA 0/1: zasocitinib–zasocitinib (n = 255), zasocitinib–placebo (n = 126). Number of patients for PASI 75: zasocitinib–zasocitinib (n = 273), zasocitinib–placebo (n = 134). Number of patients for PASI 90: zasocitinib–zasocitinib (n = 238), zasocitinib–placebo (n = 122) . P values for comparison versus zasocitinib–placebo (in gray) based on a stratified Cochran–Mantel–Haenszel test: ***p < 0.001; ***† nominal p <0.001. PASI, Psoriasis Area and Severity Index; sPGA, static Physician’s Global Assessment. †


 
Zasocitinib: Enabling expansion with focused LCM programs 19 PHASE 2 START PHASE 2b READOUT PHASE 3 START PHASE 3 READOUT FILING Psoriasis March 2023 Nov 2023 Dec 2025 Target FY2026 Psoriasis H2H vs deucravacitinib July 2025 Target FY2026 Psoriasis Pediatric Dec 2025 Psoriatic Arthritis Sept 2023 March 2024 Target FY2027 Crohn’s Disease March 2024 (Ph2b) Target FY2026 Ulcerative Colitis June 2024 (Ph2b) Target FY2026 Vitiligo Dec 2025 (Ph2b) Hidradenitis Suppurativa Feb 2026 (Ph2a) Milestone achieved All timelines are approximate estimates as of March 28, 2026 are subject to change and are subject to clinical and regulatory success. Table is not comprehensive. For full glossary of abbreviations please refer to appendix.


 
Zasocitinib was generally well-tolerated • The safety profile of zasocitinib was consistent with that previously reported1 • No observed trends in labs over time such as cholesterol or lipids increases2 20 Week 24 3001 Study 3002 Study sPGA 0/1 74% 71% PASI 90 69% 63% sPGA 0 49% 41% PASI 100 42% 32% 1. Armstrong AW, Gooderham M, Lynde C, et al. Tyrosine Kinase 2 Inhibition With Zasocitinib (TAK-279) in Psoriasis: A Randomized Clinical Trial. JAMA Dermatol. 2024;160(10):1066-1074. doi:10.1001/jamadermatol.2024.2701 2. Increases in lipids such as cholesterol and triglycerides are known to be associated with JAK inhibition Zasocitinib: Rapid and durable skin clearance in a convenient once-daily pill Zasocitinib demonstrated rapid and durable skin clearance • 49% of patients achieved clear skin, sPGA 0, by week 24 • Rapid response, demonstrated by early separation for PASI 75 and sPGA 0/1 at week 4 • Durable response, >90% of patients continuing zasocitinib at week 40 maintained sPGA 0/1 and PASI 90 through week 60 • Improved quality of life was observed by week 4, with responses continuing to increase over time, reaching up to 60% of patients reporting no impact of psoriasis on daily life (DLQI 0/1) at week 24


 
Zasocitinib Market Opportunity & Commercialization 21


 
22 Conventional Therapies Biologics Orals ~1M ~1.3M 27% 40% 51% 10% 22% 1. Conventional therapies include Oral + Topical Steroid​, DMARD, & Retinoid 2. US Claim Data (IQVIA SOB Report) and Takeda Forecasting Insights Ad va nc ed T he ra py Ad va nc ed T he ra py 50% FY24 FY34 ~3x the number of patients treated with an oral therapy over the next decade (~100K to ~300K)2 Transformational efficacy with next-generation orals can give patients an opportunity to achieve clear skin without proceeding to biologics Today many moderate-to-severe psoriasis patients are sub-optimally treated with only ~50% on advanced therapies Patients often delay initiating biologic therapy due to concerns about injections, safety, and lifestyle impact, resulting in prolonged use of ineffective conventional treatments1 Next-generation orals can provide efficacious options positioned to drive significant growth of the oral segment US Psoriasis Market Growth Moderate-to-Severe (M2S) Treated Patients 1


 
Zasocitinib: Meeting patient needs with a treatment that fits effortlessly into daily life 2. Profile based on Ph3 data Rapid and Durable Skin Clearance in a Convenient Once-Daily Pill, No Fasting Restrictions2 Zasocitinib delivered clear to almost clear skin for ~70% of patients by week 16 • Rapid onset • Durable skin clearance • No new safety signals Fits effortlessly into daily life • Once daily oral dosing • Can be taken any time; no fasting restrictions 23 Photos: IFPA | All the Colors We Are It's very exciting for our community to have a potential new oral systemic option to treat their psoriasis. People living with psoriasis deserve treatment options that help them manage this disease so that they can maintain a high quality of life. It's great for them and their health care provider to have another option to turn to. Leah M. Howard, J.D. President and CEO of the National Psoriasis Foundation ” 1. Yilmaz O, Pinto JP, Torres T. New and emerging oral therapies for psoriasis. Drugs Context. 2024;13:2024-5-6. This transition towards oral therapies could lead to more convenient treatment regimens for patients, enhancing adherence and improving their quality of life.1 Orhan Yilmaz College of Medicine, University of Saskatchewan ”


 
24 Continued investment to maximize zasocitinib’s commercial impact and market potential Demonstrated success in an adjacent, highly competitive autoimmune market with Entyvio – #1 prescribed IBD treatment (UC and Crohn’s combined)1 In-depth knowledge and experience of payer dynamics to drive effective market access strategies and pull-through Early external engagement with KOLs & patient advocacy as well as continuing to build awareness of the strong safety profile consistent with selective TYK2 inhibition 1. Source: US IBD Patient Share – IQVIA Takeda’s proven immunology leadership positions it to execute a successful zasocitinib launch


 
Zasocitinib is positioned to transform and expand the oral advanced therapy market in psoriatic disease Enabling Expansion with Focused LCM Programs that Unlock Significant Future Upside Hidradenitis Suppurativa Ph2 started FY25Dermatology → Vitiligo Ph2 started FY25 Ulcerative Colitis Ph2 data expected FY26 Gastroenterology → Crohn’s Disease Ph2 data expected FY26 + 1.0M → 1.3M Moderate to Severe Psoriasis treated patients growing at low single digits 10% → 22% Significant expansion of the oral market driven by next-gen oral entrants Poised to Lead Among Oral Options in the Growing Psoriasis Market US Pso Market Evolution Over the Next Decade PsO Rapidly Expanding Within Psoriatic Disease PsA Ph3 Psoriatic Arthritis (PsA) data expected in FY27 Global Peak Revenue Potential For PsO + PsA PsO PsA $3-6B1 + = 25 1. Please refer to the Important Notice at the start of this presentation for more information about peak revenue estimates. ~3x more patients treated with an oral therapy


 
Zasocitinib: Poised to be a leading oral treatment option for patients with psoriasis – significantly expanding the oral market 1 32 Convenient once-daily pill without fasting restrictions Rapid and durable skin clearance, with no new safety signals Next-generation, highly selective oral TYK2 inhibitor Zasocitinib U.S. and global filings on track to start in FY26 26


 
Q&A Session JULIE KIM CEO Elect RHONDA PACHECO President, U.S. Business Unit; U.S. Country Head CHINWE UKOMADU Head of GI&I Therapeutic Area Unit


 
Appendix


 
29 Once-daily Oral Zasocitinib Demonstrates Rapid and Reproducible Skin Clearance with a Consistent Safety Profile in Moderate-to-Severe Plaque Psoriasis: Results from Two Randomized Phase 3 Trials (LATITUDE-PsO-3001 and 3002) Melinda Gooderham, Vivian Laquer, Jianzhong Zhang, Joanna Narbutt, Akimichi Morita, Paula Luna, Wenwen Zhang, Warren Winkelman, Edith Angellotti, Kim Papp, April Armstrong Presenting author: Dr Melinda Gooderham SKiN Centre for Dermatology, Queen’s University and Probity Medical Research, Peterborough, Ontario, Canada Presented at the 2026 AAD Annual Meeting, 27–31 March 2026, Denver, Colorado, USA Presentation #79730


 
30 Disclosures Dr Melinda Gooderham has been an investigator, speaker and/or advisor for: AbbVie, Acelyrin, Akros, Alumis, Amgen, AnaptysBio, Apogee, Arcutis, Aristea, Bausch Health, Bristol Myers Squibb, Boehringer Ingelheim, Dermavant, Dermira, Eli Lilly, Galderma, GSK, Incyte, Inmagene, JAMP Pharma, Janssen, L’Oreal, LEO Pharma, MedImmune, Meiji, Moonlake, Nektar, Nimbus, Novartis, Organon, Oruka, Pfizer, Q32 Bio, Regeneron, Sanofi Genzyme, Sun Pharma, Takeda, Tarsus, UCB, Union, Ventyx and Vyne


 
31 Zasocitinib is an investigational, oral, allosteric, highly selective and potent TYK2 inhibitor1,2 ATP, adenosine triphosphate; IFN, interferon; IL, interleukin; JAK, Janus kinase; TYK, tyrosine kinase. 1. Leit S et al. J Med Chem 2023;66:10473–96; 2. Mehrotra S et al. J Invest Dermatol 2025;146:214–22; 3. Rusiñol L and Puig L. Int J Mol Sci 2023;24:3391. 4. Armstrong A et al. JAMA Dermatol 2024;160:1066–74. • More than 1 millionfold greater binding selectivity for TYK2 versus JAK1, JAK2 and JAK31,2 • Maintains 24-hour inhibition of IL-23 plus other core disease-driving immune pathways2,3 • Well tolerated and efficacious in a phase 2b trial in patients with moderate-to-severe plaque psoriasis4 Objective: To evaluate the efficacy and safety of zasocitinib in adults with moderate-to-severe plaque psoriasis in two pivotal phase 3 studies: LATITUDE-PsO-3001 (NCT06088043) and LATITUDE-PsO-3002 (NCT06108544)


 
32 LATITUDE-PsO-3001 and 3002 were randomized, multicenter, double-blind, placebo- and apremilast-controlled phase 3 trials Eligibility • Adults (≥ 18 years) • Plaque psoriasis diagnosis for ≥ 6 months prior to screening • PASI ≥ 12, sPGA ≥ 3, ≥ 10% BSA • Candidate for phototherapy or systemic therapy aWith a ≥ 2-point decrease from baseline. bWith a baseline DLQI score ≥2. BSA, body surface area; DLQI, Dermatology Life Quality Index; F/U, follow-up; PASI, Psoriasis Area and Severity Index; sPGA, static Physician’s Global Assessment; TEAE, treatment-emergent adverse events. Endpoints Co-primary endpoints at Week 16 (versus placebo): • sPGA 0/1a • PASI 75 Key secondary endpoints (versus placebo or apremilast) included: • PASI 75 at Week 4 • sPGA 0, PASI 75/90/100 or DLQI 0/1b at Week 16 or 24 • sPGA 0/1 or PASI 75 maintenance at Week 60 Safety endpoints included: • TEAEs; laboratory parameters


 
33aWith a ≥ 2-point decrease from baseline. bWith a baseline DLQI score ≥2. BSA, body surface area; DLQI, Dermatology Life Quality Index; F/U, follow-up; PASI, Psoriasis Area and Severity Index; sPGA, static Physician’s Global Assessment; TEAE, treatment-emergent adverse events. Eligibility • Adults (≥ 18 years) • Plaque psoriasis diagnosis for ≥ 6 months prior to screening • PASI ≥ 12, sPGA ≥ 3, ≥ 10% BSA • Candidate for phototherapy or systemic therapy Endpoints Co-primary endpoints at Week 16 (versus placebo): • sPGA 0/1a • PASI 75 Key secondary endpoints (versus placebo or apremilast) included: • PASI 75 at Week 4 • sPGA 0, PASI 75/90/100 or DLQI 0/1b at Week 16 or 24 • sPGA 0/1 or PASI 75 maintenance at Week 60 Safety endpoints included: • TEAEs; laboratory parameters LATITUDE-PsO-3001 and 3002 were randomized, multicenter, double-blind, placebo- and apremilast-controlled phase 3 trials


 
34 LATITUDE-PsO-3001 LATITUDE-PsO-3002 Baseline demographics and characteristics were generally similar across treatment arms in each study Data are mean (SD) unless otherwise stated. aData missing for one patient receiving zasocitinib (LATITUDE-PsO-3002). bData missing for three patients receiving zasocitinib and one receiving apremilast (LATITUDE-PsO-3001), and for three patients receiving zasocitinib, one patient receiving apremilast, and four patients receiving placebo (LATITUDE-PsO-3002). BMI, body mass index; BSA, body surface area; DLQI, Dermatology Life Quality Index; PASI, Psoriasis Area and Severity Index; SD, standard deviation; sPGA, static Physician’s Global Assessment. Zasocitinib (n = 416) Apremilast (n = 137) Placebo (n = 140) Zasocitinib (n = 555) Apremilast (n = 276) Placebo (n = 277) Age, years 43.8 (13.26) 46.0 (14.10) 45.3 (13.54) 45.8 (13.33) 46.1 (13.37) 46.5 (13.19) Sex, male, n (%) 295 (70.9) 95 (69.3) 93 (66.4) 367 (66.1) 187 (67.8) 188 (67.9) Race, White, n (%) 255 (61.3) 88 (64.2) 87 (62.1) 472 (85.0) 233 (84.4) 240 (86.6) BMI, kg/m2 29.7 (6.8) 28.5 (6.3) 28.2 (6.5) 30.2 (6.8) 30.1 (6.5) 30.4 (7.2) Psoriasis duration, median (range) yearsa 13.6 (0.6–62.4) 14.0 (0.6–71.3) 12.5 (0.6–59.3) 15.1 (0.5–69.2) 16.5 (0.6–60.5) 15.1 (0.6–65.9) PASI score 19.7 (7.5) 20.5 (9.0) 20.3 (7.4) 21.3 (9.3) 21.4 (8.6) 21.1 (8.5) sPGA score 3 (moderate), n (%) 329 (79.1) 116 (84.7) 112 (80.0) 473 (85.2) 237 (85.9) 228 (82.3) 4 (severe), n (%) 85 (20.4) 21 (15.3) 28 (20.0) 80 (14.4) 39 (14.1) 48 (17.3) BSA, % 24.0 (14.0) 25.8 (15.9) 24.2 (14.4) 27.9 (17.8) 27.8 (16.5) 27.0 (16.3) DLQI scoreb 12.7 (7.2) 11.1 (6.5) 12.2 (7.3) 11.6 (7.2) 11.5 (6.7) 12.2 (7.4) Bio-experienced, n (%) 141 (33.9) 40 (29.2) 45 (32.1) 155 (27.9) 80 (29.0) 83 (30.0)


 
35 Zasocitinib met the co-primary endpoints in both studies (sPGA 0/1 and PASI 75 versus placebo at Week 16) aWith a ≥ 2-point decrease from baseline. Number of patients based on the full analysis set with non-responder imputation. LATITUDE-PsO-3001: zasocitinib (n = 416), apremilast (n = 137), placebo (n = 140). LATITUDE-PsO-3002: zasocitinib (n = 555), apremilast (n = 276), placebo (n = 277). P values for comparison versus apremilast (in blue) and versus placebo (in gray) based on a stratified Cochran–Mantel–Haenszel test: ***p < 0.001. CI, confidence interval; PASI, Psoriasis Area and Severity Index; sPGA, static Physician’s Global Assessment. sPGA 0/1a LATITUDE-PsO-3001 sPGA 0/1a LATITUDE-PsO-3002


 
36 Zasocitinib met the co-primary endpoints in both studies (sPGA 0/1 and PASI 75 versus placebo at Week 16) aWith a ≥ 2-point decrease from baseline. Number of patients based on the full analysis set with non-responder imputation. LATITUDE-PsO-3001: zasocitinib (n = 416), apremilast (n = 137), placebo (n = 140). LATITUDE-PsO-3002: zasocitinib (n = 555), apremilast (n = 276), placebo (n = 277). P values for comparison versus apremilast (in blue) and versus placebo (in gray) based on a stratified Cochran–Mantel–Haenszel test: ***p < 0.001. CI, confidence interval; PASI, Psoriasis Area and Severity Index; sPGA, static Physician’s Global Assessment. PASI 75 LATITUDE-PsO-3001 PASI 75 LATITUDE-PsO-3002 sPGA 0/1a LATITUDE-PsO-3001 sPGA 0/1a LATITUDE-PsO-3002


 
37 Zasocitinib led to greater proportions of patients achieving PASI 90 than apremilast or placebo as early as Week 4 Number of patients based on the full analysis set with non-responder imputation. LATITUDE-PsO-3001: zasocitinib (n = 416), apremilast (n = 137), placebo (n = 140). LATITUDE-PsO-3002: zasocitinib (n = 555), apremilast (n = 276), placebo (n = 277). P values for comparison versus apremilast (in blue) and versus placebo (in gray) based on a stratified Cochran–Mantel–Haenszel test: ***p < 0.001. CfB, change from baseline; CI, confidence interval; PASI, Psoriasis Area and Severity Index; sPGA, static Physician’s Global Assessment. PASI 90 LATITUDE-PsO-3001 PASI 90 LATITUDE-PsO-3002


 
38 Zasocitinib led to greater proportions of patients achieving PASI 90 than apremilast or placebo as early as Week 4 Number of patients based on the full analysis set with non-responder imputation. LATITUDE-PsO-3001: zasocitinib (n = 416), apremilast (n = 137), placebo (n = 140). LATITUDE-PsO-3002: zasocitinib (n = 555), apremilast (n = 276), placebo (n = 277). P values for comparison versus apremilast (in blue) and versus placebo (in gray) based on a stratified Cochran–Mantel–Haenszel test: ***p < 0.001. CfB, change from baseline; CI, confidence interval; PASI, Psoriasis Area and Severity Index; sPGA, static Physician’s Global Assessment. Baseline Week 16 PASI: 15.8 sPGA: 3 PASI: 0.7 (CfB 95.6%) sPGA: 0 PASI 90 LATITUDE-PsO-3001 PASI 90 LATITUDE-PsO-3002


 
39 Zasocitinib led to greater proportions of patients achieving clear skin versus apremilast or placebo as early as Week 8 Number of patients based on the full analysis set with non-responder imputation. LATITUDE-PsO-3001: zasocitinib (n = 416), apremilast (n = 137), placebo (n = 140). LATITUDE-PsO-3002: zasocitinib (n = 555), apremilast (n = 276), placebo (n = 277). P values for comparison versus apremilast (in blue) and versus placebo (in gray) based on a stratified Cochran–Mantel–Haenszel test: ***p < 0.001. CI, confidence interval; PASI, Psoriasis Area and Severity Index; sPGA, static Physician’s Global Assessment. sPGA 0 LATITUDE-PsO-3001 sPGA 0 LATITUDE-PsO-3002 PASI 100 LATITUDE-PsO-3001 PASI 100 LATITUDE-PsO-3002


 
40 Zasocitinib led to greater proportions of patients achieving clear skin versus apremilast or placebo as early as Week 8 Number of patients based on the full analysis set with non-responder imputation. LATITUDE-PsO-3001: zasocitinib (n = 416), apremilast (n = 137), placebo (n = 140). LATITUDE-PsO-3002: zasocitinib (n = 555), apremilast (n = 276), placebo (n = 277). P values for comparison versus apremilast (in blue) and versus placebo (in gray) based on a stratified Cochran–Mantel–Haenszel test: ***p < 0.001. CI, confidence interval; PASI, Psoriasis Area and Severity Index; sPGA, static Physician’s Global Assessment. Baseline PASI: 31.3 sPGA: 3 PASI: 0 sPGA: 0 Week 16 PASI 100 LATITUDE-PsO-3001 PASI 100 LATITUDE-PsO-3002


 
41 Zasocitinib demonstrated superior improvement in DLQI versus apremilast or placebo as early as Week 4 aBased on evaluable patients defined as a subset of full analysis set with a baseline DLQI score ≥2 (with nonresponder imputation). Number of evaluable patients for LATITUDE-PsO-3001:zasocitinib (n = 406), apremilast (n = 133), placebo (n = 133). Number of evaluable patients for LATITUDE-PsO-3002: zasocitinib (n = 525), apremilast (n = 263), placebo (n = 260). P values for comparison versus apremilast (in blue) and versus placebo (in gray) based on a stratified Cochran–Mantel–Haenszel test: ***p < 0.001. CI, confidence interval; DLQI, Dermatology Life Quality Index. DLQI 0/1a LATITUDE-PsO-3001 DLQI 0/1a LATITUDE-PsO-3002


 
42 Zasocitinib was well tolerated with no new safety signals identified through Week 24 TEAEs were coded using MedDRA v28.1. bSample size adjusted incidence proportion x 100. c95% Wald CI unless 0 events occur in either trial, in which case a 95% exact binomial CI is used. Most frequently reported adverse events occurring in ≥ 5% of patients in any treatment group, based on individual preferred term. CI, confidence interval; MedDRA, Medical Dictionary for Regulatory Activities; aEvents starting while on initial treatment are included. dDeath occurred 1 day after first dose date (unrelated to treatment). e SAE, serious adverse event; TEAE, treatment-emergent adverse event; URTI, upper respiratory tract infection. • Most TEAEs were mild or moderate • Laboratory parameters (e.g. lymphocytes, liver enzymes, lipids) demonstrated no clinically meaningful trends over time in both studies TEAEs from LATITUDE-PsO-3001 and 3002a Zasocitinib (n = 970) Apremilast (n = 412) Placebo (n = 417) Zasocitinib (n = 970) Apremilast (n = 412) n %b (95% CI)c n %b (95% CI)c n %b (95% CI)c n %b (95% CI)c n %b (95% CI)c Any TEAE 605 62.1 (59.0–65.1) 207 50.5 (45.7–55.4) 196 46.9 (42.0–51.7) 674 69.3 (66.4–72.2) 232 56.5 (51.7–61.4) Leading to discontinuation 31 3.2 (2.1–4.3) 11 2.6 (1.1–4.2) 3 < 1 (0.0–1.6) 36 3.7 (2.5–4.9) 13 1.3 (1.4–4.7) SAE 29 3.0 (1.9–4.1) 6 1.5 (0.3–2.7) 2 < 1 (0.1–1.7) 35 3.6 (2.4–4.8) 7 1.7 (0.5–3.0) Death 1d < 1 (0.0–0.6)d 0 0 (0.0–0.9) 0 0 (0.0–0.9) 1d < 1 (0.0–0.6)d 0 0 (0.0–0.9) Most frequent TEAE (≥ 5%)e URTI 100 10.1 (8.2–12.0) 24 6.0 (3.7–8.3) 13 3.2 (1.5–4.8) 123 12.5 (10.4–14.6) 29 7.4 (4.8–10.0) Acne 62 6.5 (5.0–8.1) 3 < 1 (0.0–1.7) 1 < 1 (0.0–1.3) 70 7.3 (5.6–8.9) 3 < 1 (0.0–1.7) Nasopharyngitis 60 6.2 (4.7–7.7) 23 5.4 (3.2–7.5) 20 4.7 (2.7–6.6) 80 8.3 (6.5–10.0) 34 7.9 (5.4–10.5) Diarrhea 30 3.1 (2.0–4.2) 33 8.2 (5.5–10.9) 8 1.8 (0.6–3.1) 36 3.7 (2.5–4.9) 33 8.2 (5.5–10.9) Headache 27 2.8 (1.8–3.9) 26 6.3 (4.0–8.7) 8 1.9 (0.6–3.2) 32 3.3 (2.2–4.5) 28 6.8 (4.4–9.3) Nausea 20 2.1 (1.2–3.0) 23 5.5 (3.3–7.8) 5 1.2 (0.1–2.2) 23 2.4 (1.4–3.4) 24 5.8 (3.5–8.1) Day 0 to Week 24Day 0 to Week 16


 
43 More than 90% of patients continuing zasocitinib at Week 40 maintained sPGA 0/1, PASI 75 and PASI 90 through Week 60 sPGA 0/1 PASI 75 Evaluable patients based on the full analysis set for randomized withdrawal with nonresponder imputation. Number of patients for sPGA 0/1: zasocitinib–zasocitinib (n = 255), zasocitinib–placebo (n = 126). Number of patients for PASI 75: zasocitinib–zasocitinib (n = 273), zasocitinib–placebo (n = 134). Number of patients for PASI 90: zasocitinib–zasocitinib (n = 238), zasocitinib–placebo (n = 122) . P values for comparison versus zasocitinib–placebo (in gray) based on a stratified Cochran–Mantel–Haenszel test: ***p < 0.001; ***† nominal p <0.001. PASI, Psoriasis Area and Severity Index; sPGA, static Physician’s Global Assessment. LATITUDE-PsO-3002 randomized withdrawal Most (59%, 69% and 52%) patients re-randomized from zasocitinib to placebo at Week 40 maintained sPGA 0/1, PASI 75, and PASI 90, respectively, for an additional ~5 months PASI 90


 
44 Conclusions Once-daily oral zasocitinib demonstrated rapid reproducible and durable skin clearance, and a consistent safety and laboratory parameter profile, across two pivotal phase 3 trials • Clear skin was achieved by ~one-third of zasocitinib-treated patients by Week 16 • More than 90% of patients continuing zasocitinib at Week 40 maintained sPGA 0/1, PASI 75 and PASI 90 through Week 60 • Zasocitinib demonstrated superior improvement in QoL versus placebo or apremilast • Zasocitinib was generally well tolerated with no new safety signals identified Zasocitinib efficacy and safety will be further evaluated in patients with moderate- to-severe plaque psoriasis in a 3-year long-term extension study (NCT06550076) and an ongoing head-to-head trial versus deucravacitinib (NCT06973291) PASI, Psoriasis Area and Severity Index; QoL, quality of life; sPGA, static Physician’s Global Assessment.


 
45 Acknowledgments We would like to acknowledge and thank all study sites and patients for their participation in this study This study was funded by Takeda Development Center Americas, Inc. Medical writing assistance was provided by Tina Borg, PhD, of Oxford PharmaGenesis, UK, under the direction of the authors, and was funded by Takeda Development Center Americas, Inc. Zasocitinib-related presentations at AAD 2026 Oral presentation slides: LATITUDE-PsO-3001 and 3002 phase 3 topline results ePoster: Phase 2b study early onset of response correlated to biomarkers