Teva Pharmaceuticals, in partnership with Sanofi, announced on Tuesday promising results from a Phase 2b trial for its experimental drug duvakitug, aimed at treating Crohn’s disease and colitis. The drug exceeded expectations, demonstrating significant efficacy compared to a placebo and positioning Teva to compete in the $28 billion global market for inflammatory bowel disease (IBD) treatments.
Teva shares surged more than 15% in pre-market trading on the New York Stock Exchange following the announcement.
In the 14-week trial conducted in the U.S., Europe, and Israel, duvakitug showed that 36.2% of patients on a low dose and 47.8% of patients on a high dose achieved clinical remission, compared to 20.4% in the placebo group. The companies noted that results were consistent across subgroups, and emphasized that this is the first randomized, placebo-controlled study to evaluate the impact of a TL1A antibody in Crohn’s disease.
“This is the most promising drug in Teva’s pipeline,” the company said, as it eyes entry into the competitive IBD market. Teva now faces rivals such as Roche and Merck, both of which recently reported strong Phase 2 results for their own treatments. Globally, 10 million people suffer from IBD, including ulcerative colitis and Crohn’s, with many patients remaining untreated and battling chronic inflammation.
Teva entered into a co-development agreement with Sanofi last year. Under the deal, Sanofi paid Teva $500 million upfront, with up to $1 billion in milestone payments. Teva will receive $600 million upon entering Phase 3 trials, expected to begin in 2025, and an additional $400 million when the drug reaches commercial launch, projected toward the end of the decade. Development costs will be split equally between the companies.
If the drug is approved, Teva will handle its launch in Europe and Israel, while Sanofi will manage commercialization in the U.S., Asia and other global markets. Profits will be split evenly between the two companies.
“The results from the study have exceeded our expectations,” said Eric Hughes, Teva’s head of global R&D and chief medical officer.
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Sanofi’s head of R&D, Houman Ashrafian, added: “These unprecedented results show that duvakitug could represent the next frontier in treating ulcerative colitis and Crohn’s disease. If the magnitude of effect persists in the Phase 3 program, we believe we will have a differentiated medicine for IBD patients who are in urgent need of new options.”
Teva and Sanofi reported that duvakitug was generally well tolerated, with no safety signals identified.
Detailed results from the trial are expected to be presented at a scientific forum in 2025.