Teva Pharmaceutical and Sanofi have announced positive results from their Phase 2b RELIEVE UCCD study of duvakitug, an investigational anti-TL1A therapy, for the treatment of ulcerative colitis (UC) and Crohn's disease (CD). The study met its primary endpoints in both UC and CD, suggesting a potential new treatment option for these inflammatory bowel diseases.
Phase 2b Trial Results
The RELIEVE UCCD study evaluated the efficacy and safety of duvakitug in patients with UC and CD. In UC patients, 36.2% of those receiving a low dose and 47.8% receiving a high dose of duvakitug achieved clinical remission at week 14, compared to 20.45% in the placebo group. This translates to placebo-adjusted remission rates of 15.7% for the low dose and 27.4% for the high dose.
For CD patients, the study assessed endoscopic response. Results showed that 26.1% of patients in the low-dose group and 47.8% in the high-dose group achieved an endoscopic response, compared to 13% in the placebo group.
Implications and Future Plans
According to Teva, this study marks the first randomized, placebo-controlled trial evaluating an anti-TL1A monoclonal antibody in Crohn's disease. Houman Ashrafian, head of research & development at Sanofi, stated that the results indicate duvakitug could represent a significant advancement in treating UC and CD.
The companies plan to initiate a Phase 3 trial for duvakitug, contingent upon regulatory discussions. Detailed results from the RELIEVE UCCD study are expected to be presented at a future medical meeting.
Market Impact
The positive results have significantly impacted the stock performance of both companies. Teva's U.S.-traded shares surged, reaching their highest level in six years, while Sanofi's shares also experienced an increase. BofA Securities has raised its price target for Teva, citing the strong Phase 2 data and forecasting potential peak sales of approximately $2 billion for duvakitug.
Partnership Details
Sanofi in-licensed the joint development and commercialization rights for duvakitug from Teva last year. Teva will lead commercialization in Europe, Israel, and other specified countries, while Sanofi will handle commercialization in North America, Japan, and other parts of Asia. Both companies will equally share development costs and net profits/losses in major markets. Sanofi made an upfront payment of $500 million to Teva and is eligible for up to $1 billion in milestone payments.
