Teva Pharmaceutical Industries Limited and partner Sanofi reported that their joint Phase 2b maintenance study—named RELIEVE UCCD long‑term extension—has achieved durable clinical remission in ulcerative colitis and endoscopic response in Crohn’s disease over a 44‑week, double‑blind, randomized extension that enrolled 130 patients who had previously responded to induction therapy. Patients were re‑randomized to receive either 450 mg or 900 mg of subcutaneous duvakitug every four weeks. The 900‑mg cohort saw 58 % of ulcerative colitis patients reach clinical remission and 55 % of Crohn’s disease patients achieve endoscopic response, while the 450‑mg cohort achieved 47 % remission and 41 % endoscopic response, respectively. All patients reported the treatment as well tolerated, with the most common adverse events—upper respiratory tract infection, nasopharyngitis, and hypertension—mirroring the safety profile observed in the induction phase.
The durable efficacy observed over 44 weeks addresses a critical unmet need in inflammatory bowel disease: maintaining remission after initial response. By targeting TL1A, a protein that amplifies inflammation and fibrosis, duvakitug offers a novel mechanism distinct from existing TNF inhibitors and other biologics. The strong maintenance data reinforce the drug’s best‑in‑class potential and provide a compelling rationale for advancing to phase 3 trials, which are already underway. Successful phase 3 outcomes would support regulatory submissions and could unlock a significant new revenue stream for both companies.
"One of the persistent challenges in treating ulcerative colitis and Crohn's disease isn't just achieving an initial response, but sustaining it. These Phase 2b results further reinforce TL1A as a compelling target and clearly strengthen the case that duvakitug has the potential to be a best‑in‑class therapy. They also provide further evidence to support additional indications we anticipate announcing this year, with the goal of bringing meaningful innovation to patients," said Eric Hughes, MD, PhD, Executive Vice President, Global R&D and Chief Medical Officer at Teva. "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. 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," added Houman Ashrafian, Executive Vice President, Head of Research and Development at Sanofi.
The findings dovetail with Teva’s pivot to growth strategy, which emphasizes innovative products and a broader biosimilars portfolio. In Q4 2025, Teva received a $500 million milestone payment from Sanofi for initiating phase 3 trials, underscoring the partnership’s financial momentum. For Sanofi, duvakitug represents a critical diversification of its pipeline as the blockbuster Dupixent approaches its 2031 patent cliff. The phase 2b maintenance data strengthen the case for continued investment and position duvakitug as a potential flagship product in the IBD market, projected to reach $31–$42 billion by 2030‑2035.
While the February 17 announcement did not trigger an immediate market reaction, the December 2024 phase 2b induction results had previously spurred a nearly 20 % surge in Teva shares and a 5 % rise in Sanofi, reflecting investor enthusiasm for the drug’s early promise. The current maintenance data reinforce that enthusiasm and suggest a strong likelihood of regulatory approval and commercial success if phase 3 trials confirm these results.
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