Sanofi (NASDAQ: SNY) and Teva Pharmaceutical Industries Ltd. (NYSE: TEVA) announced new positive data from the RELIEVE UCCD Phase IIb long‑term extension (LTE) study (NCT05668013) at United European Gastroenterology (UEG) Week 2026, demonstrating that duvakitug, their investigational anti‑TL1A human monoclonal antibody, maintained clinically meaningful efficacy improvements across multiple endpoints over 44 weeks in patients with moderately‑to‑severely active ulcerative colitis (UC) or Crohn’s disease (CD).
Study Snapshot – UEG Week 2026
| Item | Detail |
|---|---|
| Companies | Sanofi (NASDAQ: SNY) and Teva Pharmaceutical Industries (NYSE: TEVA) |
| Product | Duvakitug – investigational human monoclonal antibody targeting TL1A |
| Study | RELIEVE UCCD Phase IIb long‑term extension (LTE) (NCT05668013) |
| Population | Patients with moderately‑to‑severely active ulcerative colitis (UC) or Crohn’s disease (CD) |
| Duration | 44 weeks of maintenance treatment |
| Venue | United European Gastroenterology (UEG) Week 2026 |
| Headline Result | Maintained clinically meaningful efficacy improvements across multiple endpoints |
Drug Profile & Mechanism of Action
- Molecule: Duvakitug, an investigational human monoclonal antibody targeting TL1A (TNF‑like ligand 1A).
- Dual Pathology Target: TL1A is a protein that amplifies inflammation and potentially drives fibrosis in UC and CD — positioning upstream TL1A blockade to address both inflammatory and fibrotic disease drivers.
- First‑in‑Class Potential: Anti‑TL1A is one of the most closely watched novel mechanisms in inflammatory bowel disease, differentiated from TNF, IL‑23 and integrin inhibitors by its dual inflammation‑and‑fibrosis biology.
- Administration: Maintenance treatment evaluated over 44 weeks in the LTE setting; dosing details not disclosed.
Clinical Evidence – RELIEVE UCCD LTE (Week 44)
| Endpoint | Measure | Result at Week 44 |
|---|---|---|
| Clinical Remission & Response – UC | Modified Mayo Score (mMS) | High rates of clinical remission and response – rectal bleeding, increased stool frequency and abdominal pain resolved (remission) or improved (response) |
| Endoscopic Improvement – UC | Mayo Endoscopic Score 0 or 1 | High rates – MES 0 (inactive colonic disease) or 1 (mild activity), measuring presence and extent of intestinal inflammation |
| Endoscopic Response – CD | ≥ 50 % decrease from baseline in SES‑CD | High rates achieved – SES‑CD assesses mucosal ulcers, ulcerated surface, endoscopic extent and stenosis |
| Clinical Remission & Response – CD | Crohn’s Disease Activity Index (CDAI) | High rates maintained – abdominal pain, diarrhea and fatigue resolved (remission) or improved (response) |
Across both indications, duvakitug maintenance treatment delivered high rates of clinical remission and clinical response, endoscopic improvement in UC (MES 0–1), and endoscopic response in CD (≥ 50 % SES‑CD reduction from baseline) at Week 44. Numerical endpoint rates, subgroup analyses and safety data were not disclosed in the announcement.
Market Impact & Outlook
- Durability Signal: Sustained efficacy over 44 weeks addresses a key question for IBD biologics — whether response is maintained on long‑term therapy — strengthening duvakitug’s profile for chronic maintenance treatment.
- Dual‑Indication Franchise: Efficacy across both UC and CD positions Sanofi and Teva’s partnership to pursue one of the largest combined addressable markets in immunology, spanning two major inflammatory bowel diseases.
- Mechanism Validation: As TL1A blockade advances with positive LTE data, the first‑in‑class mechanism gains credibility against entrenched anti‑TNF, anti‑IL‑23 and anti‑integrin standards of care, with fibrosis modification as a potential differentiator in CD.
- Competitive Landscape: The anti‑TL1A class is a crowded race among major pharma; consistent, multi‑endpoint 44‑week data help duvakitug defend its position within the pipeline hierarchy.
- Disclosures: Phase III program timing, regulatory filing plans, and commercial forecasts were not disclosed beyond the UEG Week 2026 presentation.
Forward‑Looking Statements
This brief contains forward‑looking statements regarding the clinical development, regulatory pathway, and commercialization expectations for duvakitug in ulcerative colitis and Crohn’s disease. Actual results may differ materially due to risks including Phase III trial outcomes, regulatory review timelines, competitive dynamics in the IBD biologics market, and market adoption. Presentation of Phase IIb extension data does not guarantee eventual approval.-Fineline Info & Tech
