Teva and Sanofi’s Best-in-Class IBD Drug a Game-Changer in the Antibody Therapeutics Arena

Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd. (NYSE: TEVA), and Sanofi (NASDAQ: SNY) announced positive Phase 2b results. The RELIEVE UCCD study met primary endpoints in patients with ulcerative colitis and Crohn’s disease. Duvakitug (TEV’574/SAR447189) is a human IgG1-λ2 monoclonal antibody targeting TL1A. The treatment focuses on moderate-to-severe inflammatory bowel disease (IBD), addressing significant clinical needs with its best in class potential. 

Best-in-Class Potential: 47.8% of Ulcerative Colitis and Crohn’s Disease Patients Achieve Clinical Remission with High-Dose Duvakitug

French drugmaker Sanofi and Israel’s Teva Pharmaceuticals announced that their study of an experimental drug for ulcerative colitis and Crohn’s disease met its primary goals. The companies believe that the biologic’s best-in-class potential could offer a new treatment option for IBD patients.

The positive results of the Phase 2b RELIEVE UCCD study, which evaluated duvakitug (TEV’574/SAR447189), a human IgG1-λ2 monoclonal antibody targeting TL1A focused on patients with moderate-to-severe IBD, including ulcerative colitis and Crohn’s disease. In the study, 47.8% of ulcerative colitis patients receiving the high dose of duvakitug achieved clinical remission at week 14, compared to 20.45% of those on placebo. Similarly, 47.8% of Crohn’s disease patients on the high dose achieved endoscopic response, while only 13% of those on placebo showed similar results.

Teva announced that this study is “the first and only randomized, placebo-controlled trial to evaluate the impact of an anti-TL1A monoclonal antibody in Crohn’s disease.” The results showed that high-dose duvakitug achieved the highest primary endpoint results for any TL1A monoclonal antibody, demonstrating its potential as a new treatment for IBD. In the ulcerative colitis cohort, 36.2% of low-dose and 47.8% of high-dose patients reached clinical remission, compared to 15.7% and 27.4% in the low- and high-dose groups, respectively, achieving endoscopic response for Crohn’s disease.

“These unprecedented results show that duvakitug could represent the next frontier in treating ulcerative colitis and Crohn’s disease,” said Dr. Houman Ashrafian, PhD, Executive Vice President, Head of R&D at Sanofi. “If the magnitude of effect persists in the Phase III programme, we believe we will have a differentiated medicine for IBD patients who are in urgent need of new options.” The companies did not disclose further details, which are set to be presented at a scientific forum in 2025.

Duvakitug Shows Promise with 27% Remission Rate, Surpassing Merck and Roche in IBD Treatment

Duvakitug targets TL1A, a protein that regulates inflammation and fibrosis. This protein has attracted attention due to its potential to treat hard-to-manage IBD cases more effectively and durably than current treatments.

Merck & Co. purchased Prometheus Biosciences for nearly $11 billion in April 2023, primarily to acquire a TL1A blocker showing promise in Phase 2 testing. Following this, Roche spent $7 billion on Televant, and AbbVie joined the pursuit earlier this year, announcing a license agreement with FutureGen.

Duvakitug is behind Merck’s and Roche’s therapies, with Merck already in Phase 3 testing. However, Teva has long argued that duvakitug could outperform them. In October 2023, Sanofi invested $500 million in a collaboration with Teva to advance development. This partnership boosts Teva’s chance at a branded blockbuster drug, while it gives Sanofi a way to strengthen investor confidence in its pipeline.

While cross-trial comparisons can be tricky, duvakitug’s Phase 2 results appear strong. Merck’s drug showed a placebo-adjusted remission rate of 25% in ulcerative colitis, while Roche’s therapy produced an 18-23% difference in a similar trial, depending on the dose. Duvakitug’s 27% difference, along with higher disease improvement in Crohn’s disease, suggests that its unique design may lead to better efficacy, according to Jefferies analyst Welford.

Duvakitug Aiming for Blockbuster Status with $1 Billion in Annual Sales

This research and development project started last year when Teva and Sanofi teamed up to develop a treatment for IBD, aiming for it to become a blockbuster drug with annual sales of at least $1 billion. Although the results come from a short Phase 2 trial, the partners’ findings indicate that duvakitug may be the most potent drug among several closely watched antibody therapies for IBD, such as similar treatments by Merck and Roche. With no cure, therapies in the IBD space have great potential.

In the market, Teva’s U.S.-traded shares climbed to their highest level in six years, rising more than 26% to $20.88. The stock has nearly doubled in price this year. Meanwhile, Sanofi’s U.S.-traded shares climbed over 7%, reaching $49.10. 

The companies plan to advance to a Phase 3 trial for duvakitug, pending regulatory discussions. This progression into Phase 3 will trigger a $600 million milestone payment from Sanofi to Teva. “If the magnitude of effect persists in the Phase 3 program, we believe we will have a differentiated medicine for IBD,” said Houman Ashrafian, Sanofi’s R&D chief.

Sanofi will lead the Phase III clinical development program for Teva’s duvakitug as a treatment for ulcerative colitis and Crohn’s disease. Teva will handle commercialization in countries such as Europe and Israel, while Sanofi will manage commercialization in North America, Asia, and other global regions.

Author

Bernice Lottering