A Teva Pharmaceuticals drug being developed in partnership with Sanofi to hit a promising but competitive target for inflammation now has positive data from a clinical test in the two most common types of inflammatory bowel disease (IBD), results the companies say support the antibody’s best-in-class potential.
The preliminary results announced Tuesday are from a placebo-controlled Phase 2b test that enrolled 240 patients with either ulcerative colitis or Crohn’s disease. The experimental drug, duvakitug, was administered as a subcutaneous injection every two weeks for 14 weeks.
In ulcerative colitis, 36.2% of those treated with the low dose and 47.8 of those treated with the high dose achieved clinical remission compared to 20.45% of those given a placebo. In Crohn’s disease, endoscopic response was achieved by 26.1% of those in the low-dose group and 47.8% in the high-dose group. Just 13% of those in the placebo arm met that mark. Teva said these responses to duvakitug were both statistically significant and clinically meaningful.
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On measures of safety, the companies said duvakitug was well tolerated in both the ulcerative colitis and Crohn’s cohorts. They added that rates of adverse events were similar between the study drug arms and the placebo groups. The companies plan to present more Phase 2b details at an upcoming scientific meeting in 2025. But with these encouraging preliminary results in hand, the companies are now preparing for a longer and larger IBD Phase 3 study, which will be led by Sanofi.
Duvakitug goes after a target called tumor necrosis factor (TNF)-like ligand 1A, or TL1A. Signaling of this protein is believed to drive inflammation and fibrosis associated with IBD. TL1A binds to two receptors, one that maintains homeostasis and the other which promotes pro-inflammatory signaling, Teva said in an investor presentation. By selectively binding to DR3, the pro-inflammatory receptor, duvakitug is intended to mitigate the signaling that drives IBD. The drug was initially discovered and developed by Teva, which is better known as a maker of generic and biosimilar medicines. But the company has also been devoting resources to the R&D of novel drugs that offer the potential for stronger revenue growth.
Last year, Sanofi signed on as a partner in the development of duvakitug, formerly known as TEV-48574. The pharma giant paid €469 million (about $500 million) up front, and committed to up to €940 million (about $1 billion) in milestone payments. It’s one of several deals in what has become a hot area of inflammatory drug research. Merck’s TL1A-targeting drug, tulisokibart, came via an acquisition, as did Roche’s contender, RO7790121. Both are in mid-stage clinical development. Further behind but still in the hunt is AbbVie, which struck a deal earlier this year that brought a preclinical drug candidate that targets TL1A.
In a note sent to investors, Leerink Partners analyst David Risinger characterized the duvakitug results as “surprisingly compelling.” In both ulcerative colitis and Crohn’s, the drug’s data appear stronger than its competitors. Cross-trial comparisons come with caveats due to differences in study designs, but Risinger said duvakitug is showing greater placebo-adjusted efficacy versus its competitors in the TL1A class. However, he also noted that duvakitug’s study tested dosing every two weeks while rival drug candidates were tested with dosing every four weeks.
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Teva and Sanofi are gathering data for the longer dosing interval. Participants who completed the 14-week Phase 2b test could continue receiving treatment in a long-term extension study lasting 44 weeks. Dosing in this study is every four weeks. Following the positive preliminary Phase 2b results, the next steps include discussions with regulators about Phase 3.
“These unprecedented results show that duvakitug could represent the next frontier in treating ulcerative colitis and Crohn’s disease,” Houman Ashrafian, executive vice president, head of R&D at Sanofi, said in a prepared statement. “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.”
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