Duvakitug phase 2b maintenance data highlights a clinically meaningful durable efficacy in ulcerative colitis and Crohn’s disease

Sanofi has recently announced their new positive results from the RELIEVE UCCD long-term extension study of duvakitug, an investigational human monoclonal antibody targeting TL1A, showed durable clinical and endoscopic efficacy maintained over 44 weeks in patients with ulcerative colitis and Crohn’s disease that initially responded to the induction phase. RELIEVE UCCD LTE is a double-blind randomized study evaluating the long-term efficacy, safety, and tolerability of duvakitug in UC and CD, the two most common forms of inflammatory bowel disease.

“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,” said Houman Ashrafian, Executive Vice President, Head of Research and Development, Sanofi. “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.”

Note that the study enrolled 130 patients who responded to duvakitug in the RELIEVE UCCD induction study and entered a 44-week maintenance period. Patients were re-randomized to receive either a 450 mg or 900 mg subcutaneous dose of duvakitug every four weeks for up to a total of 58 weeks of exposure. At week 44 of the maintenance period:

• UC: 58% (900 mg) and 47% (450 mg) of patients treated with duvakitug achieved the primary endpoint of clinical remission per the modified Mayo score (mMS).
• CD: 55% (900 mg) and 41% (450 mg) of patients treated with duvakitug achieved the primary endpoint of endoscopic response as defined by the Simple Endoscopic Score for CD (SES-CD).
• In both UC and CD, consistent benefits were observed across additional efficacy endpoints.

In addition, both of the doses of duvakitug were well tolerated. The most frequent observed adverse events with pooled duvakitug doses were upper respiratory tract infection, nasopharyngitis, Crohn’s disease, and hypertension and were consistent with the RELIEVE UCCD phase 2b induction study. Detailed results from the study will be presented at a forthcoming medical meeting.

“One of the persistent challenges in treating ulcerative colitis and Crohn’s disease isn’t just achieving an initial response, but sustaining it,” said Eric Hughes, MD, PhD, Executive Vice President, Global R&D and Chief Medical Officer, Teva. “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.”

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Related Topics and Keywords

Crohn's disease, duvakitug, phase 2b trial, Sanofi, Teva, ulcerative colitis