Teva and Sanofi's Duvakitug Shows Durable Efficacy in UC and Crohn's Disease Phase 2b Data

Teva Pharmaceuticals and Sanofi announced positive long-term results from the RELIEVE UCCD long-term extension (LTE) study of duvakitug, an investigational human monoclonal antibody targeting TL1A, showing durable clinical and endoscopic efficacy maintained over 44 weeks in patients with ulcerative colitis (UC) and Crohn's disease (CD).

The Phase 2b RELIEVE UCCD LTE study, a double-blind randomized trial (NCT05668013), enrolled 130 patients who had responded to duvakitug during the 14-week induction phase. 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. The longer duration data reinforce the efficacy from the RELIEVE UCCD Phase 2b induction study, which demonstrated that patients achieved clinically meaningful response with duvakitug compared to placebo at week 14.

In UC, 58% of patients in the 900 mg cohort and 47% in the 450 mg cohort achieved the primary endpoint of clinical remission per the modified Mayo score (mMS). In CD, 55% and 41% of patients receiving the 900 mg and 450 mg doses, respectively, 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.

Both doses of duvakitug were well tolerated. The most frequently observed adverse events (≥5% of all patients) 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 Teva's Executive Vice President of Global R&D and Chief Medical Officer. "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."

Sanofi's Executive Vice President, Head of Research and Development, added: "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."

Duvakitug is currently in Phase 3 clinical studies for the treatment of UC and CD. The STARSCAPE-1 and STARSCAPE-2 trials are underway in CD (NCT07184931 and NCT07184944), and the SUNSCAPE-1 and SUNSCAPE-2 trials are underway in UC (NCT07184996 and NCT07185009). Sanofi paid Teva $500 million for rights to codevelop and co-commercialize the anti-TL1A therapy in 2023.

TL1A is an emerging drug class which has gained significant pharmaceutical interest, noted by prominent industry acquisitions. Merck purchased Prometheus and its anti-TL1A pipeline therapy PRA023, now known as tulisokibart, for $10.8 billion in 2023. Roche acquired Televant in a $7.1 billion deal in 2023, which included rights to RVT-3101. Market forecasts project the UC market across eight major markets will be valued at $9.6 billion in 2031, while the CD market is due to be worth $13.8 billion across the eight major markets in 2032.