Sanofi and Teva disclosed that their investigational monoclonal antibody duvakitug achieved durable clinical and endoscopic efficacy in the RELIEVE UCCD long‑term extension (LTE) study, a 44‑week maintenance trial for ulcerative colitis (UC) and Crohn’s disease (CD). The study enrolled 130 patients who had responded to duvakitug during the induction phase and were re‑randomized to receive either 450 mg or 900 mg subcutaneously every four weeks for up to 58 weeks of exposure.
At week 44 of the maintenance period, both dose levels were well tolerated. The most frequent adverse events—upper respiratory tract infection, nasopharyngitis, Crohn’s disease, and hypertension—occurred in 5 % or more of patients. The data demonstrate sustained remission rates, with 58 % of UC patients achieving clinical remission at 900 mg and 47 % at 450 mg, while 55 % of CD patients achieved endoscopic response at 900 mg and 41 % at 450 mg.
The results reinforce duvakitug’s potential as a leading therapy for inflammatory bowel disease (IBD). Houman Ashrafian, Executive Vice President of Research and Development at Sanofi, said, "These results reinforce duvakitug's potential as a leading TL1A therapy and an important advancement in inflammatory bowel disease treatment with durable efficacy maintained for nearly one year in patients living with ulcerative colitis or Crohn's disease." He added, "With phase 3 studies underway, we're committed to advancing duvakitug for patients who need new options, and it remains a key opportunity in our pipeline."
The collaboration between Sanofi and Teva, announced in October 2023, positions Sanofi to lead the Phase 3 development while Teva receives upfront payments and milestone incentives. The positive LTE data support the launch of Phase 3 trials, which are expected to enroll several hundred patients and evaluate long‑term safety and efficacy across a broader patient population.
The announcement comes amid a competitive TL1A landscape, with Merck’s acquisition of Prometheus Biosciences for its anti‑TL1A agent MK‑7240 and Roche’s purchase of Roivant’s RVT‑3107. The data also align with Teva’s 2026 growth strategy, which projects revenues of $16.4–$16.8 billion and positions duvakitug as a key contributor to future value. Teva’s Q4 2025 earnings—$4.71 billion in revenue and $0.96 in non‑GAAP diluted EPS—beat analyst estimates, while Sanofi’s Q4 2025 results—net sales of €11.3 billion and business EPS of €1.53—also exceeded forecasts.
The durable efficacy and favorable safety profile of duvakitug strengthen both companies’ immunology pipelines and support their broader strategic focus on innovative biologics. The data provide a compelling rationale for continued investment in the TL1A pathway and signal a potential shift in the competitive dynamics of IBD therapeutics.
The findings underscore the importance of sustained clinical benefit in chronic conditions and reinforce the companies’ commitment to delivering new treatment options for patients with ulcerative colitis and Crohn’s disease.
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