Satya Bio Report | Updated February 2, 2026
Head-to-head comparison of clinical efficacy data across development programs (sorted by placebo-adjusted response)
| Drug | Trial | Dose | Endpoint | Result | Placebo | Δ vs Placebo | Population | Source |
|---|---|---|---|---|---|---|---|---|
| Tulisokibart (PRA023) | ARTEMIS-UC | 1000mg → 500mg Q4W | Endoscopic Improvement | 49% | 13% | 36% ★ | TL1A-high biomarker positive | NEJM 2024 |
| Afimkibart (RVT-3101) | Phase 2 | 150mg Q4W | Clinical Response | 70% | 35% | 35% | All patients | ACG 2023 |
| Duvakitug (TEV-48574) | RELIEVE UCCD | 1000mg Q4W | Clinical Remission | 47.8% | 20.4% | 27.4% | All patients | DDW 2024 |
| Tulisokibart (PRA023) | ARTEMIS-UC | 1000mg → 500mg Q4W | Clinical Remission | 26% | 1% | 25% | TL1A-high biomarker positive | NEJM 2024 |
| Afimkibart (RVT-3101) | Phase 2 | 150mg Q4W | Clinical Remission | 35% | 12% | 23% | All patients | ACG 2023 |
| Duvakitug (TEV-48574) | RELIEVE UCCD | 500mg Q4W | Clinical Remission | 32.6% | 20.4% | 12.2% | All patients | DDW 2024 |
★ = Best-in-class result | Purple = biomarker-selected population
Strategic positioning and key differentiators for each development program
| Drug | Strategy | Dosing | Biomarker | Half-Life | Beyond Lead Indication |
|---|---|---|---|---|---|
| Tulisokibart (PRA023) | Precision medicine | 1000mg → 500mg Q4W SC | Yes (TL1A-high) | ~14 days | SSc-ILD, RA explored |
| Duvakitug (TEV-48574) | Best-in-class efficacy | 500-1000mg Q4W SC | No | ~21 days | IBD only |
| Afimkibart (RVT-3101) | Multi-indication expansion | 150mg Q4W SC | No | ~14 days | AD, MASH, Celiac potential |
| SAR443765 (Bispecific) | Dual-target synergy | TBD | No | TBD | IBD focus |
| Risk | Severity | Mitigation |
|---|---|---|
| Crowded competitive landscape with 3+ Phase 3 assets | High | Differentiation through precision medicine (biomarker selection) or best-in-class efficacy |
| Cross-trial comparison challenges make differentiation unclear | Medium | Phase 3 data will clarify; some head-to-head studies possible |
| Safety signals in large trials could derail class | Medium | Phase 2 data shows clean safety profiles across programs |
| Payer resistance if efficacy not clearly differentiated | Medium | Fibrosis benefit may provide unique value proposition |
| Sponsor | Trials | Type |
|---|---|---|
| Biocad | 3 | Industry |
| Merck Sharp & Dohme LLC | 3 | Industry |
| Bispebjerg Hospital | 1 | Academic |
| Vial Australia Pty Ltd | 1 | Industry |
| Nova Scotia Health Authority | 1 | Academic |
8 assets tracked • 4 deals worth $18.6B • 2 in Phase 3
BTD Breakthrough Therapy ODD Orphan Drug PRIME EU Priority FT Fast Track
| NCT ID | Title | Phase | Status | Sponsor | Enrollment | Start |
|---|---|---|---|---|---|---|
| NCT01744327 | TL1A Expression in Psoriatic Skin | Not Applicable | Unknown | Bispebjerg Hospital | 20 | 2012-12 |
| NCT07080034 | Study of the Efficacy, Safety, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of BCD-261 in Subjects With Moderate to Severe Active Ulcerative Colitis | Phase 2 | Recruiting | Biocad | 198 | 2025-08-14 |
| NCT07029971 | A First-in-Human Study of BB-TL1A-VIAL-HLE in Healthy Adults and People With Ulcerative Colitis | Phase 1 | Terminated | Vial Australia Pty Ltd | 16 | 2025-06-23 |
| NCT06715540 | Safety, Pharmacodynamics, Pharmacokinetics, and Immunogenicity of Ascending Doses BCD-261 in Healthy Subjects | Phase 1 | Recruiting | Biocad | 48 | 2024-03-29 |
| NCT01229202 | Use of Bevacizumab to Modulate the Outcomes of Trabeculectomy Surgery | Phase 4 | Withdrawn | Nova Scotia Health Authority | - | 2008-07 |
| NCT07078994 | Clinical Study of the Efficacy, Safety, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of BCD-261 in Subjects With Moderate to Severe Active Crohn's Disease | Phase 2 | Recruiting | Biocad | 204 | 2025-08-14 |
| NCT06430801 | A Study to Evaluate the Efficacy and Safety of Tulisokibart (MK-7240) in Participants With Moderate to Severe Crohn's Disease (MK-7240-008) | Phase 3 | Recruiting | Merck Sharp & Dohme LLC | 1200 | 2024-06-05 |
| NCT06651281 | Extension Study of Long-term Safety and Efficacy of Tulisokibart in Participants With Crohn's Disease or Ulcerative Colitis (MK-7240-011) | Phase 3 | Recruiting | Merck Sharp & Dohme LLC | 1380 | 2024-11-25 |
| NCT06052059 | A Study to Evaluate Efficacy and Safety of Tulisokibart (MK-7240) in Participants With Moderately to Severely Active Ulcerative Colitis (MK-7240-001) | Phase 3 | Recruiting | Merck Sharp & Dohme LLC | 1020 | 2023-10-25 |
| PMID | Title | Authors | Journal | Year |
|---|---|---|---|---|
| 35911746 | Role of TL1A in Inflammatory Autoimmune Diseases: A Comprehensive Review. | Xu, Li, Huang | [object Object] | 2022 |
| 39266053 | Targeting TL1A and DR3: the new frontier of anti-cytokine therapy in IBD. | Bamias, Menghini, Pizarro et al. | [object Object] | 2025 |
| 38574740 | TL1A inhibition for inflammatory bowel disease treatment: From inflammation to fibrosis. | Solitano, Jairath, Ungaro et al. | [object Object] | 2024 |
| 40010414 | TL1A, a novel alarmin in airway, intestinal, and autoimmune disorders. | Varricchi, Poto, Criscuolo et al. | [object Object] | 2025 |
| 39907869 | TL1A Inhibition in Inflammatory Bowel Disease: A Pipeline Review. | Solitano, Estevinho, Ungaro et al. | [object Object] | 2025 |
| 30972074 | TL1A (TNFSF15) and DR3 (TNFRSF25): A Co-stimulatory System of Cytokines With Diverse Functions in Gut Mucosal Immunity. | Valatas, Kolios, Bamias | [object Object] | 2019 |
| 33475057 | TL1A: A New Potential Target in the Treatment of Inflammatory Bowel Disease. | Furfaro, Alfarone, Gilardi et al. | [object Object] | 2021 |
| 39772947 | The TL1A inhibitors in IBD: what's in the pot? | Lusetti, Bezzio, De Bernardi et al. | [object Object] | 2025 |
| 34126262 | Anti-TL1A Antibody PF-06480605 Safety and Efficacy for Ulcerative Colitis: A Phase 2a Single-Arm Study. | Danese, Klopocka, Scherl et al. | [object Object] | 2021 |
| 29436901 | An anti-TL1A antibody for the treatment of asthma and inflammatory bowel disease. | Clarke, Poulton, Shim et al. | [object Object] | 2018 |
| 39521604 | TL1A: A model for a precision medicine approach in the treatment of Crohn's disease and ulcerative colitis. | Bilsborough, Targan | [object Object] | 2024 |
| 32958689 | TL1A Promotes Lung Tissue Fibrosis and Airway Remodeling. | Herro, Miki, Sethi et al. | [object Object] | 2020 |
| 40507829 | TL1A as a Target in Inflammatory Bowel Disease: Exploring Mechanisms and Therapeutic Potential. | Tettoni, Gabbiadini, Dal Buono et al. | [object Object] | 2025 |
| 18598698 | TL1A (TNFSF15) regulates the development of chronic colitis by modulating both T-helper 1 and T-helper 17 activation. | Takedatsu, Michelsen, Wei et al. | [object Object] | 2008 |
| 39321363 | Phase 2 Trial of Anti-TL1A Monoclonal Antibody Tulisokibart for Ulcerative Colitis. | Sands, Feagan, Peyrin-Biroulet et al. | [object Object] | 2024 |
| 38597952 | TL1A is an epithelial alarmin that cooperates with IL-33 for initiation of allergic airway inflammation. | Schmitt, Duval, Camus et al. | [object Object] | 2024 |
| 33097818 | Direct signaling of TL1A-DR3 on fibroblasts induces intestinal fibrosis in vivo. | Jacob, Kumagai, Abraham et al. | [object Object] | 2020 |
| 31081141 | Association between TL1A gene polymorphisms and systemic lupus erythematosus in a Chinese Han population. | Xu, Fu, Liu et al. | [object Object] | 2019 |
| 41389712 | TL1A blockade in inflammatory bowel diseases: Clinical trials to watch. | D'Amico, Peyrin-Biroulet, Jairath et al. | [object Object] | 2025 |
| 38842774 | TL1A Promotes Fibrogenesis in Colonic Fibroblasts via the TGF-β1/Smad3 Signaling Pathway. | Song, Sun, Li et al. | [object Object] | 2024 |
Authors ranked by publication count from PubMed search results
| Name | Institution | Publications | First Author | Last Author | Status |
|---|---|---|---|---|---|
| Silvio Danese | Salute San Raffaele University | 8 | 2 | 3 | Active |
| Stephan R Targan | Widjaja Inflammatory Bowel Disease Institute | 7 | 0 | 4 | Active |
| Jun Zhang | Indiana University | 7 | 0 | 0 | Active |
| Giorgos Bamias | University of Athens | 5 | 1 | 4 | Active |
| Xiao-Lan Zhang | The Second Hospital of Hebei Medical University | 5 | 0 | 4 | Active |
| Vipul Jairath | Western University | 4 | 0 | 1 | Active |
| Laurent Peyrin-Biroulet | University of Lorraine | 4 | 0 | 0 | Active |
| Kenneth E Hung | Pfizer Inc | 4 | 0 | 2 | Active |
| Jessica R Allegretti | s Hospital | 3 | 0 | 0 | Active |
| Michael S Vincent | Pfizer Inc | 3 | 0 | 0 | Active |
| Mina Hassan-Zahraee | Pfizer Inc | 3 | 1 | 0 | Inactive |
| Srividya Neelakantan | Pfizer Inc | 3 | 0 | 0 | Active |
| Christopher Lepsy | Pfizer Inc | 3 | 0 | 1 | Inactive |
| Deepa E Chandra | Pfizer Inc | 3 | 0 | 0 | Active |
| Kathrin S Michelsen | Sinai Medical Center | 3 | 0 | 0 | Inactive |
| Brian G Feagan | University of Calgary | 3 | 1 | 1 | Active |
| David Q Shih | Sinai Medical Center | 3 | 1 | 0 | Inactive |
| Xiao-Yan Liu | Southwest Medical University | 3 | 1 | 0 | Active |
| Jia-Min Wang | Southwest Medical University | 3 | 0 | 0 | Active |
| Jia Song | The Second Hospital of Hebei Medical University | 3 | 1 | 0 | Active |